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• This study examined the impacts of a tiered program on children's socioemotional competence, behavioral adjustment, and pre-academic skills. • The program targeted second-year kindergarten students' socioemotional skills and provided additional training to third-year students with socioemotional difficulties. • After completing the program, children showed better socioemotional competence, behavioral adjustment, and pre-academic skills. Despite the importance of socioemotional competence, few social and emotional learning programs have been developed for and evaluated with non-Western communities. The Early Prevention, Early Identification, and Early Intervention Program is a tiered, school-based program targeting the socioemotional skills of all second-year kindergarten students in Chinese communities with the Little Garden Curriculum and providing additional training to third-year kindergarten students with socioemotional difficulties with the Little Greenhouse Curriculum. Using a cluster randomized controlled trial, this study examined the impacts of the program on 999 children (mean age in the pretest = 4.25 years; 48 % were girls) from 18 kindergartens from Hong Kong, China. Using kindergartens as clusters, children were randomly assigned to undertake the Little Garden Curriculum (n = 624) or join the wait-list control group (n = 375). Furthermore, children who had completed the Little Garden Curriculum but still showed socioemotional difficulties were randomly assigned to undertake the Little Greenhouse Curriculum (n = 87) or join the wait-list control group (n = 50). In other words, the intervention kindergartens used for the evaluation of the Little Garden Curriculum were randomly assigned into a new intervention group or a new wait-list control group for the evaluation of the Little Greenhouse Curriculum. In pre- and posttests, teachers rated children's socioemotional competence and behavioral adjustment, and children completed reading and arithmetic tasks. Results indicated that—controlling for child age, gender, and prior scores—children who had completed the Little Garden Curriculum showed better socioemotional competence, behavioral adjustment, and pre-academic skills (ten out of 12 outcome variables). Moreover, children who had completed the Little Greenhouse Curriculum showed higher scores on six out of 12 outcome measures. Findings highlighted the utility of using culturally relevant programs to improve the socioemotional competence of Chinese children at both the universal and the indicated levels. [ABSTRACT FROM AUTHOR]

Early childhood interventions played a critical role in improving child development in impoverished contexts. Combined nutrition and psychosocial stimulation interventions (CNPSI) have shown more benefits than stand-alone supplemental nutrition interventions (SNI) in many developing countries. Based on a cluster randomized controlled trial in rural northwestern China, this study tested alternative theory-driven hypotheses regarding how primary caregiver's education and family income may moderate the CNPSI's effects on child growth environment and developmental delay risk. The trial cluster randomized 1,566 children aged 7–33 months from 111 villages (clusters) in Huachi County, Gansu Province, into an SNI group (N = 852) and a CNPSI group (N = 714). Multilevel regression models suggested that the CNPSI group had better home growth environment (p < 0·001) and lower risk of developmental delay (p < 0·001) than the SNI group. The CNPSI's impacts on home growth environment and development delay were weaker for parents with higher education levels. However, household income did not significantly moderate the CNPSI effect for either outcome. Future interventions need to attend to the educational disparities in the resource-poor context. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study is to assess the effect of glucocorticoid prescription feedback intervention in complex primary care institutions for regulating its inappropriate use. Design, Setting and Interventions: A six-month cluster randomized cross-over controlled trial was conducted in primary care institutions. A total of 347 physicians from 69 participating institutions were randomly allocated to either group A or group B. Both groups were given feedback interventions or serve as control. The feedback intervention comprised two components: a real-time pop-up warning of inappropriate glucocorticoid prescriptions based on the Hospital Information System and a high-proportion prescription feedback intervention warning system. Outcome Measures: The primary outcome measure was the 10-day inappropriate glucocorticoid prescription rate, while the 10-day glucocorticoid prescription rate served as secondary outcome measure. Results: At baseline, the 10-day inappropriate glucocorticoid prescription rates were 66.63% and 66.57% in group A and group B, respectively, showing no significant difference (p = 0.140). Following the intervention, group A exhibited a significant reduction in 10-day inappropriate glucocorticoid prescription rate at the crossing point by 13.69% (p < 0.001). In contrast, group B, which served as the control group, experienced an increase of 5.93% (p = 0.037) at the same crossover point. After the crossover point, there was a decrease in 10-day inappropriate glucocorticoid prescription rate for both groups. Group B as the intervention group demonstrated a reduction of 28.22% compared to the crossing point (p < 0.001), whereas group A showed a decrease of 12.20% (p = 0.339). The characteristics of physicians did not significantly influence the inappropriate glucocorticoid prescription rate. Conclusion: The real-time pop-up warning of inappropriate glucocorticoid prescriptions based on the Hospital Information System and high-proportion prescription feedback intervention warning system can effectively regulate the inappropriate glucocorticoid prescribing behavior of physicians. Trial Registration: ISRCTN11747547. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is a common arrhythmia that requires anticoagulation therapy to prevent stroke. However, there is still a significant under-/over-treatment in stroke prevention for patients with AF. The adherence and the risk of bleeding associated with oral anticoagulation therapy (OACs) are major concerns. Shared decision-making (SDM) is an approach that involves patients and healthcare providers in making decisions about treatment options. This study aims to assess the effectiveness of a novel SDM tool for anticoagulation management in AF. Methods: The study will be a prospective, cluster randomized controlled trial involving 440 patients with AF in 8 community health service centers (clusters) in Shanghai, China. The SDM group will receive anticoagulation management through the novel SDM tool, while the control group will receive standard care. The follow-up period will be at least 2 years. The primary outcome will be any bleeding event, while secondary outcomes include the accordance of stroke prophylaxis for AF according to the current guidelines, time in therapeutic range (TTR), the occurrences of major bleeding and thrombosis events, and patient knowledge, adherence, and satisfaction. Discussion: This study will provide evidence of the effectiveness of shared decision-making in improving the appropriateness of OAC use in Chinese AF patients. The findings may inform the development of guidelines and policies for the management of AF and anticoagulation therapy in China and other countries. Trial registration: ChiCTR ChiCTR2200062123. Registered on 23 July 2022. [ABSTRACT FROM AUTHOR]

Background: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA‐II) prospective randomized trial showed the efficacy of a mobile health (mHealth) implemented 'Atrial fibrillation Better Care' (ABC) pathway for the integrated care management of patients with atrial fibrillation (AF). In this ancillary analysis, we evaluated the effect of mAFA intervention according to the history of diabetes mellitus (DM). Methods: The mAFA‐II trial enrolled 3324 AF patients across 40 centres in China, between June 2018 and August 2019. In this analysis, we assessed the interaction between history of DM and the effect of mAFA intervention on the risk of the primary composite outcome of stroke, thromboembolism, all‐cause death and rehospitalizations. Results were expressed as adjusted hazard ratio (aHR) and 95% confidence intervals (95%CI). The effect of mAFA intervention on exploratory secondary outcomes was also assessed. Results: Overall, 747 (22.5%) patients had DM (mean age: 72.7 ± 12.3, 39.6% females; 381 allocated to mAFA intervention). mAFA intervention was associated with a significant risk reduction for the primary composite outcome both in patients with and without DM (aHR [95%CI]:.36 [.18–.73] and.37 [.23–.61], respectively, p for interaction =.941). A significant interaction was found only for the composite of recurrent AF, heart failure and acute coronary syndromes (pint =.025), with lower effect of mAFA intervention in patients with DM. Conclusions: A mHealth‐technology implemented ABC pathway showed a consistent effect in reducing the risk of the primary composite outcome in AF patients with and without DM. Trial Registration: WHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR‐OOC‐17014138. [ABSTRACT FROM AUTHOR]

Background: Managing the multimorbidity of diabetes and depression remains a clinical challenge for patients and healthcare professionals due to the fragmented healthcare delivery system. To effectively cope with multimorbidity, there is an urgent need for the health system to transform into people-centered integrated care (PCIC) system globally. Therefore, this paper describes the protocol of community-based integrated care for patients with diabetes and depression (CIC-PDD) project, an integrated and shared-care intervention project. Methods/design: CIC-PDD project is conducted in two phases, namely "care model development" and "implementation and evaluation." In the first phase, CIC-PDD model was designed and developed based on the four criteria of collaborative care model (CCM) and was subsequently adjusted to align with the context of China. The second phase entails a pragmatic, two-arm, cluster randomized controlled implementation trial, accompanied by parallel mixed-methods process evaluation and cost-effectiveness analysis. Discussion: We anticipate CIC-PDD project will facilitate the development and innovation of PCIC model and related theories worldwide, particularly in low- and middle-income countries (LMICs). In addition, CIC-PDD project will contribute to the exploration of primary health care (PHC) in addressing the multimorbidity of physical and mental health issues. Trial registration: ClinicalTrials.gov registration ChiCTR2200065608 (China Clinical Trials Registry https://www.chictr.org.cn). Registered on November 9, 2022. [ABSTRACT FROM AUTHOR]

Background: Myopia and obesity in children and adolescents have become serious public health problems that endanger public health, especially in China. Unhealthy lifestyle behaviors are environmental drivers of both myopia and obesity. This protocol describes a study to evaluate the effectiveness of "22510SS", that is 2 h of daytime outdoor activities ('2'); Limit screen time to no more than 2 h per day ('2'); Consume at least 5 servings of fruits and vegetables daily ('5'); Attain 1 h of physical activity daily ('1'); Consume 0 sugar-sweetened beverages ('0'); Reasonable sleep duration ('S'); Regular supervision ('S'). A school-based, multifaceted intervention strategy for myopia and obesity prevention, and to assess and explore the implementation of "22510SS" with regards to acceptability, feasibility, adoption, usage and maintenance. Methods and analysis: This study aims to develop a comprehensive intervention strategy "22510SS" based on the socio-ecological model, and A two-arm cluster randomized trial with a parallel-group of a 1:1 allocation ratio in 36 primary and secondary schools to test its evidence-based intervention programs on the effects and implementation of myopia and obesity epidemics in children and adolescents in grades 4 and 7. The primary outcomes will include differences in visual acuity, body mass index, outdoor activity indicators, screen time, fruit and vegetable intake, high-quality protein intake, sugar-sweetened beverage intake, sleep duration, and level of monitoring among children and adolescents. Secondary outcomes will assess the acceptability, feasibility, uptake, use, and maintenance of the intervention. Effects on the primary and secondary outcomes will be analyzed using linear and logistic regression analyses, as well as difference-in-difference analysis, taking into account cluster effects and possible confounding factors. Process assessments will also be conducted through quantitative and qualitative analyses, including acceptability, feasibility, gender, adoption, implementation, and sustainability. Discussion: This study will evaluate the effectiveness of "22510SS" and examine its implementation in the school-based network nesting family and clinic. Following this intervention study, the integrated intervention program focused on myopia and obesity among children and adolescents have great potential to be implemented in China to promote and support healthy lifestyle behavior change and reduce the risk of myopia and obesity in children and adolescents. Trial registration: NCT05275959. Registered 23 Mach 2022. [ABSTRACT FROM AUTHOR]

Background: The poor relationship between doctors and patients is a long-standing, global problem. However, current interventions tend to focus on the training of physicians, while patient-targeted interventions still need to be improved. Considering that patients play a significant role in outpatient consultations, we developed a protocol to assess the effectiveness of the Patient Oriented Four Habits Model (POFHM) in improving doctor-patient relationships. Methods: A cross-sectional incomplete stepped-wedge cluster randomized trial design will be conducted in 8 primary healthcare institutions (PHCs). Following phase I of "usual care" as control measures for each PHC, either a patient- or doctor-only intervention will be implemented in phase II. In phase III, both patients and doctors will be involved in the intervention. This study will be conducted simultaneously in Nanling County and West Lake District. The primary outcomes will be evaluated after patients complete their visit: (1) patient literacy, (2) sense of control and (3) quality of doctor-patient communication. Finally, a mixed-effects model and subgroup analysis will be used to evaluate the effectiveness of the interventions. Discussion: Fostering good consultation habits for the patient is a potentially effective strategy to improve the quality of doctor-patient communication. This study evaluates the implementation process and develops a rigorous quality control manual using a theoretical domain framework under the collective culture of China. The results of this trial will provide substantial evidence of the effectiveness of patient-oriented interventions. The POFHM can benefit the PHCs and provide a reference for countries and regions where medical resources are scarce and collectivist cultures dominate. Trial registration: AsPredicted #107,282 on Sep 18, 2022; https://aspredicted.org/QST_MHW [ABSTRACT FROM AUTHOR]

Background: A workplace-based primary prevention intervention be an effective approach to reducing the incidence of hypertension (HTN). However, few studies to date have addressed the effect among the Chinese working population. We assessed the effect of a workplace-based multicomponent prevention interventions program for cardiovascular disease on reducing the occurrence of HTN through encouraging employees to adopt a healthy lifestyle. Methods: In this post hoc analysis of cluster randomized controlled study, 60 workplaces across 20 urban regions in China were randomized to either the intervention group (n = 40) or control group (n = 20). All employees in each workplace were asked to complete a baseline survey after randomization for obtaining sociodemographic information, health status, lifestyle, etc. Employees in the intervention group were given a 2-year workplace-based primary prevention intervention program for improving their cardiovascular health, including (1) cardiovascular health education, (2) a reasonable diet, (3) tobacco cessation, (4) physical environment promotion, (5) physical activity, (6) stress management, and (7) health screening. The primary outcome was the incidence of HTN, and the secondary outcomes were improvements of blood pressure (BP) levels and lifestyle factors from baseline to 24 months. A mix effect model was used to assess the intervention effect at the end of the intervention in the two groups. Results: Overall, 24,396 participants (18,170 in the intervention group and 6,226 in the control group) were included (mean [standard deviation] age, 39.3 [9.1] years; 14,727 men [60.4%]). After 24 months of the intervention, the incidence of HTN was 8.0% in the intervention groups and 9.6% in the control groups [relative risk (RR) = 0.66, 95% CI, 0.58 ~ 0.76, P < 0.001]. The intervention effect was significant on systolic BP (SBP) level (β = − 0.7 mm Hg, 95% CI, − 1.06 ~ − 0.35; P < 0.001) and on diastolic BP (DBP) level (β = − 1.0 mm Hg, 95% CI, − 1.31 ~ − 0.76; P < 0.001). Moreover, greater improvements were reported in the rates of regular exercise [odd ratio (OR) = 1.39, 95% CI, 1.28 ~ 1.50; P < 0.001], excessive intake of fatty food (OR = 0.54, 95% CI, 0.50 ~ 0.59; P < 0.001), and restrictive use of salt (OR = 1.22, 95% CI, 1.09 ~ 1.36; P = 0.001) in intervention groups. People with a deteriorating lifestyle had higher rates of developing HTN than those with the same or improved lifestyle. Subgroup analysis showed that the intervention effect of BP on employees with educational attainment of high school above (SBP: β = − 1.38/ − 0.76 mm Hg, P < 0.05; DBP: β = − 2.26/ − 0.75 mm Hg, P < 0.001), manual labor workers and administrative worker (SBP: β = − 1.04/ − 1.66 mm Hg, P < 0.05; DBP: β = − 1.85/ − 0.40 mm Hg, P < 0.05), and employees from a workplace with an affiliated hospital (SBP: β = − 2.63 mm Hg, P < 0.001; DBP: β = − 1.93 mm Hg, P < 0.001) were significantly in the intervention group. Conclusions: This post hoc analysis found that workplace-based primary prevention interventions program for cardiovascular disease were effective in promoting healthy lifestyle and reducing the incidence of HTN among employees. Trial registration: Chinese Clinical Trial Registry No. ChiCTR-ECS-14004641. [ABSTRACT FROM AUTHOR]

Background Drowning is the leading cause of death for children under the age of 15 years in Guangdong Province, China. This serious public health issue also exists in low- and middle-income countries (LMICs), which have few value-integrated intervention programs. The current study presents an integrated intervention project that aims to explore an effective pattern of prevention for child drowning in rural areas and feasibility to perform in other LMICs. Methods We conducted a cluster randomized controlled trial by comparing the incidence of non-fatal drowning among children in two groups in rural areas of southern China. We recruited the participants in two phases and reached a total of 10 687 students from 23 schools at two towns in Guangdong Province, China. At the first and second phases, 8966 and 1721 students were recruited, respectively. Results The final evaluation questionnaires were collected after 18 months of integrated intervention, where we obtained 9791 data from Grades 3–9. The incidence of non-fatal drowning between the intervention and control groups after intervention did not differ significantly from the baseline according to the total number of students, male students, female students and Grades 6–9 [0.81; 95% confidence interval (CI): [0.66, 1.00]; p  =   0.05, 1.17; 95% CI: [0.90, 1.51]; p  =   0.25, 1.40; 95% CI: [0.97, 2.02]; p  =   0.07 and 0.97; 95% CI: [0.70, 1.34]; p  =   0.86], except for Grades 3–5 (1.36; 95% CI: [1.02, 1.82]; p  =   0.037). The study observed a significantly positive benefit of awareness and risk behaviours of non-fatal drowning between the intervention and control groups (0.27, 95% CI: [0.21, 0.33]; p  =   0.00, −0.16; 95% CI: [−0.24, −0.08]; p  =   0.00). Conclusions The integrated intervention exerted a significant impact on the prevention and management of child non-fatal drowning, especially in rural areas. [ABSTRACT FROM AUTHOR]

Background: International consensus shows that community-based rehabilitation (CBR) service is an effective way to improve functioning and negative symptoms and address the treatment gap for schizophrenia. Rigorous trials are needed in China to demonstrate effective and scalable CBR interventions to significantly improve outcomes for people with schizophrenia and to provide evidence of the economic benefits. The objectives of this trial are to examine the effectiveness of CBR as an adjunct to test the usual facility-cased care (FBC) in comparison to FBC alone in improving a range of outcomes in people with schizophrenia and their caregivers. Methods: This trial is a cluster randomized controlled trial design in China. The trial will be conducted at three districts of Weifang city, Shandong province. Eligible participants will be identified from the psychiatric management system where community-dwelling patients with schizophrenia have been registered. Participants will be recruited after providing informed consent. 18 sub-districts will be randomly allocated in a 1:1 ratio to facility-based care (FBC) plus CBR (intervention arm) or FBC alone (control arm). The structured CBR intervention will be delivered by trained psychiatric nurses or community health workers. We aim to recruit 264 participants. The primary outcomes include symptoms of schizophrenia, personal and social function, quality of life, family burden of caring, etc. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. Discussion: If the hypothesized clinical benefit and cost-effectiveness of CBR intervention are confirmed, this trial will provide significant implications for policy makers and practitioners to scale up rehabilitation services, as well as for people with schizophrenia and their family to promote recovery and social inclusion, and to alleviate the burden of care. Trial registration: Chinese Clinical Trial Registry (ChiCTR2200066945). Registered December 22, 2022. [ABSTRACT FROM AUTHOR]

Background: While community-based eldercare has proven to be effective in qualitative studies, there is limited evidence on the effectiveness of this geriatric care model in rural communities where caring for older people is traditionally the responsibility of family members, but a formal long-term care was recently introduced in China. CIE is a rural community-embedded intervention using multidisciplinary team, to provide evidenced-based integrated care services for frail older people including social care services and allied primary healthcare and community-based rehabilitation services. Methods: CIE is a prospective stepped-wedge cluster randomized trial conducted at 5 community eldercare centers in rural China. The multifaceted CIE intervention, guided by chronic care model and integrated care model, consists of five components: comprehensive geriatric assessment, individualized care planning, community-based rehabilitation, interdisciplinary case management, and care coordination. The intervention is rolled out in a staggered manner in these clusters of centers at an interval of 1 month. The primary outcomes include functional status, quality of life, and social support. Process evaluation will also be conducted. Generalized linear mixed model is employed for binary outcomes. Discussion: This study is expected to provide important new evidence on clinical effectiveness and implementation process of an integrated care model for frail older people. The CIE model is also unique as the first registered trial implementing a community-based eldercare model using multidisciplinary team to promote individualized social care services integrated with primary healthcare and community-based rehabilitation services for frail older people in rural China, where formal long-term care was recently introduced. Trial registration {2a}: China Clinical Trials Register (http://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR2200060326). May 28th, 2022. [ABSTRACT FROM AUTHOR]

Background: Interactive and experiential learning programs have proven effective to teach children safety and prevent child unintentional injury. However, previously-published programs were designed primarily to address safety concerns of children living in urban, well-resourced areas, and therefore might be less effective or economically infeasible to distribute to children in resource-limited areas, such as those living in rural areas or underdeveloped regions. This proposed study will evaluate the effectiveness of teaching children safety lessons to rural preschoolers in China through the preschool-based Safety Experience Room intervention that was developed based on relevant theories, the lessons of previous intervention research, the characteristics of child injuries in underdeveloped rural areas, and the needs and circumstances of rural families and preschools in China. The study will also evaluate the cost-effectiveness of delivering the program. Methods and analysis: A single-blinded, 12-month follow-up, parallel-group cluster randomized controlled trial with a 1:1 allocation ratio will be implemented in two selected counties. In total, at least 2378 rural preschoolers aged 3–6 years old will be recruited from 12 preschools, 6 in Yang County and 6 in Shicheng County. Clusters will be randomized at the preschool level and allocated to the control group (routine school-based education) or the intervention group (routine school-based education plus the Safety Experience Room education). External support strategies will be implemented by local partners to minimize attrition. Data collection will be conducted at baseline and then every 3 months during a 12-month follow-up time period. Intention-to-treat (ITT) data analysis will be used. Generalized estimation equations (GEE) will evaluate the effectiveness of the program and generalized cost-effectiveness analysis (GCEA) will evaluate the cost-effectiveness of it. A per-protocol (PP) sensitivity analysis will assess the robustness of ITT results. Subgroup analyses will be performed to evaluate the impact of socio-demographic factors on the intervention effect, following the same strategies as the primary analyses. Discussion: The newly-designed Safety Experience Room program is expected to be feasible, effective, and financially beneficial. If these hypotheses prove true, we will take steps to disseminate the program to rural preschools across China. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn), CHiCTR2000038025, registered on 8 September 2020. [ABSTRACT FROM AUTHOR]

Background: Many lifestyle interventions have demonstrated efficacy up to one-year follow-up, yet maintaining improvements at longer-term follow-up is a well-recognized worldwide challenge, especially in underserved areas. The purpose of this study is to compare the 18-month efficacy of an Intensive LifeStyle Modification Program to usual care in reducing the risk for type 2 diabetes (T2D) among women with a history of gestational diabetes mellitus (GDM). Methods: We conducted a two-arm, cluster randomized controlled trial among women with a history of GDM in China. A total of 16 towns (clusters) in two distinct rural areas in south-central China were randomly selected (8 towns per area) and assigned (1:1) to the intervention (Intensive LifeStyle Modification Program) or control (usual care) group with stratification in the two rural areas. The strategies for maintaining intervention effects were used (including setting recursive goals and providing a supportive environment, etc.) under the guidance of social cognitive theory. The primary outcome was a change in T2D risk; secondary outcomes included glycemic, weight-related, behavioral, and psychological variables. All outcomes were collected at baseline, 6, and 18 months. All participants entered the intention-to-treat analysis. Data were analyzed via generalized estimation equation models (accounting for clusters) at the individual level, with subgroup analysis included in the model. Results: The sample included 320 women from 16 clusters (20 women per cluster). At 18 months, the intervention group demonstrated a significant improvement in T2D risk score, fasting blood glucose, body mass index (BMI), waist circumference, intention to eat low glycemic index food, perceived stress, quality of life in psychological and environmental domains, and social support over time (p < 0.05) based on the intention-to-treat analysis set. Subgroup analysis showed a significant interaction effect on T2D risk score in subgroups of different BMI, waist circumference, and blood glucose (p < 0.05). Conclusions: Over 18 months, the Intensive LifeStyle Modification Program reduced T2D risk among rural women with a history of GDM in China. Women who were overweight, had high abdominal adiposity, or had blood glucose intolerance benefited more from this intervention. This program serves as a potential diabetes prevention model for women with a history of GDM in low-resource settings worldwide. Trial registration: Registered on Chinese Clinical Trial Registry (ChiCTR1800015023) on 1st March 2018, http://www.chictr.org.cn/showproj.aspx?proj=25569 [ABSTRACT FROM AUTHOR]

Background: Effectiveness of integrated care management for common, comorbid physical and mental disorders has been insufficiently examined in low- and middle-income countries (LMICs). We tested hypotheses that older adults treated in rural Chinese primary care clinics with integrated care management of comorbid depression and hypertension (HTN) would show greater improvements in depression symptom severity and HTN control than those who received usual care.Methods and Findings: The study, registered with ClinicalTrials.gov as Identifier NCT01938963, was a cluster randomized controlled trial with 12-month follow-up conducted from January 1, 2014 through September 30, 2018, with analyses conducted in 2020 to 2021. Participants were residents of 218 rural villages located in 10 randomly selected townships of Zhejiang Province, China. Each village hosts 1 primary care clinic that serves all residents. Ten townships, each containing approximately 20 villages, were randomly selected to deliver either the Chinese Older Adult Collaborations in Health (COACH) intervention or enhanced care-as-usual (eCAU) to eligible village clinic patients. The COACH intervention consisted of algorithm-driven treatment of depression and HTN by village primary care doctors supported by village lay workers with telephone consultation from centrally located psychiatrists. Participants included clinic patients aged ≥60 years with a diagnosis of HTN and clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10). Of 2,899 eligible village residents, 2,365 (82%) agreed to participate. They had a mean age of 74.5 years, 67% were women, 55% had no schooling, 59% were married, and 20% lived alone. Observers, older adult participants, and their primary care providers (PCPs) were blinded to study hypotheses but not to group assignment. Primary outcomes were change in depression symptom severity as measured by the Hamilton Depression Rating Scale (HDRS) total score and the proportion with controlled HTN, defined as systolic blood pressure (BP) <130 mm Hg or diastolic BP <80 for participants with diabetes mellitus, coronary heart disease, or renal disease, and systolic BP <140 or diastolic BP <90 for all others. Analyses were conducted using generalized linear mixed effect models with intention to treat. Sixty-seven of 1,133 participants assigned to eCAU and 85 of 1,232 COACH participants were lost to follow-up over 12 months. Thirty-six participants died of natural causes, 22 in the COACH arm and 14 receiving eCAU. Forty COACH participants discontinued antidepressant medication due to side effects. Compared with participants who received eCAU, COACH participants showed greater reduction in depressive symptoms (Cohen's d [±SD] = -1.43 [-1.71, -1.15]; p < 0.001) and greater likelihood of achieving HTN control (odds ratio [OR] [95% CI] = 18.24 [8.40, 39.63]; p < 0.001). Limitations of the study include the inability to mask research assessors and participants to which condition a village was assigned, and lack of information about participants' adherence to recommendations for lifestyle and medication management of HTN and depression. Generalizability of the model to other regions of China or other LMICs may be limited.Conclusions: The COACH model of integrated care management resulted in greater improvement in both depression symptom severity and HTN control among older adult residents of rural Chinese villages who had both conditions than did eCAU.Trial Registration: ClinicalTrials.gov Identifier NCT01938963 https://clinicaltrials.gov/ct2/show/NCT01938963. [ABSTRACT FROM AUTHOR]

Background: Among rural Chinese patients with non-communicable diseases (NCDs), low socioeconomic status increases the risk of developing NCDs and associated financial burdens in paying for medicines and treatments. Despite the chronic disease medicine reimbursement policy of the local government in Nantong City, China, various barriers prevent patients from registering for and benefitting from the policy. This study aims to develop a behavior science-based intervention program for promoting the adoption of the policy and to evaluate the effectiveness of the program compared with usual practices.Methods: Barriers and opportunities affecting stakeholders in adopting the policy were identified through contextual research and summarized through behavior mapping. The intervention is designed to target these barriers and opportunities through behavior science theories and will be evaluated through a 6-month cluster randomized controlled trial in Tongzhou District, Nantong, China. A total of 30 villages from two townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual practices). Village doctors in the intervention arm (1) receive systematic training on policy details, registration procedures, and intervention protocol, (2) promote the policy and encourage registration, (3) follow up with patients in the first, third, and sixth months after the intervention, and (4) receive financial incentives based on performance. The primary outcome is policy registration rate and the secondary outcomes include the number of patients registering for the policy, medical costs saved, frequency of village doctor visits, and health measures such as blood pressure and glucose levels.Discussion: This study is one of very few that aims to promote adoption of NCDs outpatient medication reimbursement policies, and the first study to evaluate the impact of these policies on patients' financial and physical wellbeing in China. The simple, feasible, and scalable intervention is designed based on the theories of behavior science and is applicable to similar low-income regions nationwide where outpatient medical costs remain a financial burden for patients.Trial Registration: ClinicalTrials.gov NCT04731194 , registered on 29 January 2021; Chinese Clinical Trial Registry ChiCTR2100042152 , registered on 14 January 14 2021. [ABSTRACT FROM AUTHOR]

Background and objective: This study was performed to investigate the effect of expressive art therapy (EAT) on the health status of patients with chronic obstructive pulmonary disease (COPD). Methods: This community-based cluster randomized controlled trial involved patients with COPD from 16 communities in China. Participants received either EAT plus usual care (UC) or UC only. General practitioners were trained in EAT before the intervention. The primary outcomes were depression and anxiety symptoms, measured with the Hospital Anxiety and Depression Scale (HADS) and expressed as the HADS score for depression or anxiety (HADS-D or HADS-A, respectively). The secondary outcomes were the quality of life and dyspnoea, measured with the COPD assessment test (CAT). Dyspnoea was assessed using the modified Medical Research Council (mMRC) dyspnoea scale. Lung function was expressed as the forced expiratory volume in 1 s as a percentage of the predicted value [FEV1 (% pred)]. Outcome data were collected from all participants at baseline, 2 and 6 months. Results: In total, 360 participants with COPD and comorbid depression were included in the analysis with the control group of 181 receiving UC only and the intervention group of 179 receiving EAT plus UC. The EAT group showed significantly greater improvement in the HADS-D and HADS-A scores than the UC group at 2 months (p < 0.0001 and p < 0.001, respectively) and 6 months (p < 0.001 for both). The CAT and mMRC scores were significantly lower in the EAT group than in the UC group at 2 and 6 months (p < 0.001 for all). The FEV1 (% pred) was significantly higher in the EAT group than in the UC group at 6 months (p < 0.01). Conclusion: General practitioners can deliver EAT interventions. EAT can effectively reduce anxiety and depression symptoms and dyspnoea, improve quality of life and improve the pulmonary function of patients with COPD. [ABSTRACT FROM AUTHOR]

Background: Rapid intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is crucial for improving outcomes. However, few randomized trials of interventions aimed at reducing in-hospital delay have been carried out in China. We aimed to evaluate the effect of a multicomponent intervention on thrombolytic door-to-needle time (DNT) of AIS patients via video teleconference based on the Behavior Change Wheel (BCW) method.Methods and Findings: This cluster-randomized trial, conducted between January 1, 2019 and December 31, 2019, randomly allocated 22 hospitals equally to PEITEM (Persuasion Environment reconstruction Incentivization Training Education Modeling) intervention or routine care plus stroke registry and subsequently enrolled 1,634 AIS patients receiving IVT within 4.5 hours upon stroke onset from participant hospitals. The PEITEM group received a 1-year PEITEM 6-component intervention based on the behavioral theory monthly via video teleconference. The primary outcome was the proportion of patients with a DNT of 60 minutes or less. A total of 987 patients participated in the PEITEM group (mean age, 69 years; female, 411 [41.6%]) and 647 patients in the control group (mean age, 70 years; female, 238 [36.8%]). Of all participants, the proportion of DNT ≤60 minutes in the PEITEM group was higher than in the control group (82.0% versus 73.3%; adjusted odds ratio, 1.77; 95% confidence interval (CI), 1.17 to 2.70; ICC, 0.04; P = 0.007). Among secondary outcomes, the average DNT was 43 minutes in the PEITEM group and 50 minutes in the control group (adjusted mean difference: -8.83; 95% CI, -14.03 to -3.64; ICC, 0.12; P = 0.001). Favorable functional outcome (score of 0 to 1 on the modified Rankin scale (mRS)) was achieved in 55.6% patients of the PEITEM group and 50.4% of the control group (adjusted odds ratio, 1.38; 95% CI, 1.00 to 1.90; ICC, 0.01; P = 0.049). Main study limitations include non-blinding of clinicians, and that specific interventions component responsible for the observed changes could not be determined.Conclusions: The teleconference-delivered PEITEM intervention resulted in a moderate but clinically relevant shorter DNT and better functional outcome in AIS patients receiving IVT.Trial Registration: Clinicaltrials.gov NCT03317639. [ABSTRACT FROM AUTHOR]

Objective: To investigate if a Family-Clinician Shared Decision-Making (FCSDM) intervention benefits patients, families and intensive care units (ICUs) clinicians.Methods: Six ICUs in China were allocated to intervention or usual care. 548 patients with critical illness, 548 family members and 387 ICU clinicians were included into the study. Structured FCSDM family meetings were held in the intervention group. Scales of SSDM, HADS, QoL2 and CSACD were used to assess families' satisfaction and distress, patients' quality of life, and clinicians' collaboration respectively.Results: Comparing the intervention group with the control group at post-intervention, there were significant differences in the families' satisfaction (P = 0.0001), depression level (P = 0.005), and patients' quality of life (P = 0.0007). The clinicians' mean CSCAD score was more positive in the intervention group than controls (P < 0.05). There was no significant between-group differences on ICU daily medical cost, but the intervention group demonstrated shorter number of days' stay in ICU (P = 0.0004).Conclusion: The FCSDM intervention improved families' satisfaction and depression, shortened patients' duration of ICU stay, and enhanced ICU clinicians' collaboration.Practice Implications: Further improvement and promotion of the FCSDM model are needed to provide more evidence to this field in China. [ABSTRACT FROM AUTHOR]

Background: SSaSS (Salt Substitute and Stroke Study), a 5-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium, added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events, and premature death among individuals with previous stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention.Methods: A within-trial economic evaluation of SSaSS was conducted from the perspective of the health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models.Results: Mean follow-up of the 20 995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio, 0.86 [95% CI, 0.77-0.96]; P=0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving and a >99.9% probability of being cost-effective.Conclusions: Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life among SSaSS participants. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is one of the most common cardiac arrhythmia diseases. Thromboembolic prophylaxis plays an essential role in AF therapy, but at present, general practitioners (GPs) are presumed to lack the knowledge and enthusiasm for AF management. Clinical decision support systems (CDSS), assisted by artificial intelligence, help primary care providers (PCPs) make quick, individualized, and correct clinical decisions. This primary aim of the study is to identify whether the promotion of the CDSS would improve the primary care provided to patients with AF. The secondary objectives are mainly to assess the health-economic and clinical benefits from using the CDSS, and the improvement of GPs' AF management capability.Methods: This study will be a prospective cluster randomized controlled trial, conducted among 14 community health centers in Shanghai which were randomized as the intervention group and control group in a ratio of 1:1. The intervention group will use the CDSS in the consultation of patients with AF and the control group will maintain their usual care. The trial will include 498 patients with AF and the follow-up period will be 12 months. The primary outcome is set as the proportion of antithrombotic treatment prescriptions in agreement with recommendations in the latest China's AF-related guidelines. The secondary outcomes are the frequency of consultation, the compliance rate of international normalized ratio (INR) in patients with warfarin, stroke morbidity, treatment compliance, medication satisfaction, and the cost-benefit analysis. Per-protocol (PP) analysis and the intention-to-treat (ITT) analysis will be conducted.Discussion: This study aims to identify whether the application of CDSS to manage patients with AF in China's community health centers would bring benefits for patients, physicians, and health economics.Trial Registration: Registry name: AI (Development and promotion of an AI-assisted tool for NVAF management in primary care); registry number: ChiCTR2100052307; registration date: Nov. 22nd, 2021; http://www.chictr.org.cn/showproj.aspx?proj=133849 . [ABSTRACT FROM AUTHOR]

Objectives: This study is to evaluate the efficacy of participatory ergonomic (PE) intervention on musculoskeletal disorders (MSDs) and work ability among young dental professionals in China. Methods: A cluster randomized controlled trail was conducted during 2015–2016. Twenty‐nine departments from five hospitals in the South of China were randomized into intervention (14 departments) and control (15 departments), with individuals of 125 and 138 dental professionals, respectively. Main participatory ergonomic interventions involved work posture, repetitive motions, tool usage, work break relaxation and work time re‐arrangement with total 235 ergonomic changes in the trail. Individual ergonomic risk exposure was assessed by investigator's observation using quick exposure check (QEC). Work ability index (WAI) and MSDs were collected by questionnaires at baseline, and every 3 months during the 1‐year follow‐up. Results: Follow‐up rate was 91% and 96% for the intervention and control group, respectively. Significant reductions in ergonomic risk exposure and MSD prevalence on six anatomic sites were found in the PE group during the different follow‐up stages. WAI scores improved by 1.1 (95% CI 0.43, 1.89) after the 9‐month intervention. Compared to the control, the PE participants significantly reduced MSDs on neck (OR = 2.93, 95% CI: 1.25, 4.03) and wrists/hands (OR = 2.33, 95% CI: 1.08, 4.21), marginally increased WAI scores by 0.53 (95% CI: −0.02, 1.56) due to the interventions. Conclusion: PE intervention is effective in reducing ergonomic risk exposure and MSDs on neck and wrists/hands among young dental professionals. PE ought to be offered in the early dental career for preventing MSDs. [ABSTRACT FROM AUTHOR]

Background: There are about 9.5 million people with dementia in China. Up to 99% of them are cared for by their family caregivers. Family caregivers are confronted with considerable difficulties and challenges while providing care. They often experience high levels of emotional, physical, financial, and social burdens. Caregivers in rural areas experience an even higher level of burden compared to their counterparts in urban areas due to fewer health resources for dementia care. However, so far, no intervention study has been conducted to support family caregivers in rural areas of China. The aim of this proposed study is to adapt and evaluate an evidence-based and culturally-tailored individualized telephone-based care support (ITBCS) program for family caregivers of people with dementia in rural China.Methods: A cluster randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the ITBCS compared with usual care for Chinese rural family caregivers of people with dementia. A total sample of 168 rural family caregivers will be recruited. The intervention components consist of a 3-month intensive telephone-based care support intervention followed by telephone-based follow-up consultations for 6 months. The control group will receive usual care services available for them. Outcome measures include carers' subjective burden, depressive symptoms, health-related quality of life, social support, caregiving self-efficacy, and care recipients' difficult behaviours and competence in activities of daily living at 3, 9 and 15 months after baseline. The potential cost-effectiveness of the ITBCS compared with usual care will be assessed as well.Discussion: If effective, the ITBCS program can be adapted and used in rural areas of China as a blueprint to improve the quality of home-based care for people with dementia. Findings from the present study are significant for developing evidence-based dementia care policy in rural China.Trial Registration: Chinese Clinical Trial Registry, ChiCTR2000038821 , Registered 4 April 2020, http://www.chictr.org.cn/showprojen.aspx?proj=62268 . [ABSTRACT FROM AUTHOR]

Background: Glycemic control remains suboptimal in developing countries due to critical system deficiencies. An innovative mobile health (mHealth)-enabled hierarchical diabetes management intervention was introduced and evaluated in China with the purpose of achieving better control of type 2 diabetes in primary care.Methods and Findings: A community-based cluster randomized controlled trial was conducted among registered patients with type 2 diabetes in primary care from June 2017 to July 2019. A total of 19,601 participants were recruited from 864 communities (clusters) across 25 provinces in China, and 19,546 completed baseline assessment. Moreover, 576 communities (13,037 participants) were centrally randomized to the intervention and 288 communities (6,509 participants) to usual care. The intervention was centered on a tiered care team-delivered mHealth-mediated service package, initiated by monthly blood glucose monitoring at each structured clinic visit. Capacity building and quarterly performance review strategies upheld the quality of delivered primary care. The primary outcome was control of glycated hemoglobin (HbA1c; <7.0%), assessed at baseline and 12 months. The secondary outcomes include the individual/combined control rates of blood glucose, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C); changes in levels of HbA1c, BP, LDL-C, fasting blood glucose (FBG), and body weight; and episodes of hypoglycemia. Data were analyzed using intention-to-treat (ITT) generalized estimating equation (GEE) models, accounting for clustering and baseline values of the analyzed outcomes. After 1-year follow-up, 17,554 participants (89.8%) completed the end-of-study (EOS) assessment, with 45.1% of them from economically developed areas, 49.9% from urban areas, 60.5 (standard deviation [SD] 8.4) years of age, 41.2% male, 6.0 years of median diabetes duration, HbA1c level of 7.87% (SD 1.92%), and 37.3% with HbA1c <7.0% at baseline. Compared with usual care, the intervention led to an absolute improvement in the HbA1c control rate of 7.0% (95% confidence interval [CI] 4.0% to 10.0%) and a relative improvement of 18.6% (relative risk [RR] 1.186, 95% CI 1.105 to 1.267) and an absolute improvement in the composite ABC control (HbA1c <7.0%, BP <140/80 mm Hg, and LDL-C <2.6 mmol/L) rate of 1.9% (95% CI 0.5 to 3.5) and a relative improvement of 21.8% (RR 1.218, 95% CI 1.062 to 1.395). No difference was found on hypoglycemia episode and weight gain between groups. Study limitations include noncentralized laboratory tests except for HbA1c, and caution should be exercised when extrapolating the findings to patients not registered in primary care system.Conclusions: The mHealth-enabled hierarchical diabetes management intervention effectively improved diabetes control in primary care and has the potential to be transferred to other chronic conditions management in similar contexts.Trial Registration: Chinese Clinical Trial Registry (ChiCTR) IOC-17011325. [ABSTRACT FROM AUTHOR]

BACKGROUND In China, hypertension prevalence is high and increasing while the control rate is low, especially in rural areas. Traditionally, village doctors play an important role in infectious disease control and delivering essential health services to rural residents. We aim to test the effectiveness of a village doctor-led multifaceted intervention compared with usual care on blood pressure (BP) control and cardiovascular disease (CVD) among rural residents with hypertension in China. METHODS In the China Rural Hypertension Control Project (CRHCP), a cluster randomized trial, 163 villages were randomly assigned to the village doctor-led intervention and 163 villages to control. A total of 33,995 individuals aged ≥40 years with an untreated BP ≥140/90 mm Hg or treated BP ≥130/80 mm Hg or with an untreated BP ≥130/80 mm Hg and a history of clinical CVD were recruited into the study. The village doctor-led multifaceted intervention is designed to overcome barriers at the healthcare system, provider, patient, and community levels. Village doctors receive training on standard BP measurement, protocol-based hypertension treatment, and health coaching. They also receive technical support and supervision from hypertension specialists/primary care physicians and performance-based financial incentives. Study participants receive health coaching on home BP monitoring, lifestyle changes, and adherence to medications. The primary outcome is BP control (<130/80 mm Hg) at 18 months in phase 1 and CVD events over 36 months in phase 2. CONCLUSIONS The CRHCP will provide critically important data on the effectiveness, implementation, and sustainability of a hypertension control strategy in rural China for reducing the BP-related CVD burden. CLINICAL TRIALS REGISTRATION Trial Number NCT03527719. [ABSTRACT FROM AUTHOR]

Background: Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China.Methods: We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm.Discussion: The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network.Trial Registration: Chinese Clinical Trial Registry, ChiCTR2000036988 . Registered 26 August 2020 - Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Managing noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China.Methods and Findings: Based on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in "timed up and go" test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: -2.8 mm Hg (95% CI -4.8, -0.9; p = 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p < 0.001), health-related quality of life (p = 0.008), physical activity level (p < 0.001), adherence in statin (p = 0.003) and antihypertensive medicines (p = 0.039), and performance in "timed up and go" test (p = 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting.Conclusions: In this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China.Trial Registration: ClinicalTrials.gov NCT03185858. [ABSTRACT FROM AUTHOR]

Background: The National Chest Pain Center Accreditation Program (CHANGE) is the first hospital-based, multifaceted, nationwide quality improvement (QI) initiative, to monitor and improve the quality of the ST segment elevation myocardial infarction (STEMI) care in China. The QI initiatives, as implementation strategies, include a bundle of evidence-based interventions adapted for implementation in China. During the pandemic of coronavirus disease 2019 (COVID-19), fear of infection with severe acute respiratory syndrome coronavirus 2, national lockdowns, and altered health care priorities have highlighted the program's importance in improving STEMI care quality. This study aims to minimize the adverse impact of the COVID-19 pandemic on the quality of STEMI care, by developing interventions that optimize the QI initiatives, implementing and evaluating the optimized QI initiatives, and developing scale-up activities of the optimized QI initiatives in response to COVID-19 and other public health emergencies.Methods: A stepped wedge cluster randomized control trial will be conducted in three selected cities of China: Wuhan, Suzhou, and Shenzhen. Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals. This study will conduct a rollout in these hospitals every 3 months. The 24 hospitals will be randomly assigned to four clusters, and each cluster will commence the intervention (optimized QI initiatives) at one of the four steps. We will conduct hospital-based assessments, questionnaire surveys among health care providers, community-based household surveys, and key informant interviews during the trial. All outcome measures will be organized using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, including implementation outcomes, service outcomes (e.g., treatment time), and patient outcomes (e.g., in-hospital mortality and 1-year complication). The Consolidated Framework for Implementation Research framework will be used to identify factors that influence implementation of the optimized QI interventions.Discussion: The study findings could be translated into a systematic solution to implementing QI initiatives in response to COVID-19 and future potential major public health emergencies. Such actionable knowledge is critical for implementors of scale-up activities in low- and middle-income settings.Trial Registration: ChiCTR 2100043319 . Registered on 10 February 2021. [ABSTRACT FROM AUTHOR]

Background: Despite tremendous investment worldwide, hypertension treatment and control rates remain low. The complexity and long-term dynamics of influencing factors make personalized management inevitable and challenging. This protocol describes Personalized Hypertension Management in Anhui, China (PHMA), a project that uses a package of innovative approaches in tailoring interventions to individual patient's dynamic complications and contexts.Methods/design: PHMA strives to reduce hypertension harms by eight "objective behaviors" (e.g., self-monitoring and reporting, healthy diet, physical exercise/activities). These objective behaviors are promoted through five intervention measures: support for self- monitoring, supervised machine communications, daily education or reminder messages, weekly blood pressure notification, and quarterly signed feedback. PHMA uses ten categories and over 300 variables in selecting and refining intervention procedures and content for individual patients. Efficacy of the intervention package is evaluated using a cluster randomized controlled trial design involving a total of 60 site communities and 3352 hypertension patients. Primary measure for the evaluation is systolic and diastolic blood pressure; while secondary evaluation measures include quality of life (EQ5D-5L), occurrence of hypertension-related complications (such as cerebral hemorrhage, coronary heart disease, myocardial or cerebral infarction), healthcare utilization and scores of objective behaviors.Discussion: PHMA uses novel, low cost and sustainable approaches to tailor interventions to the dynamic conditions and contexts of individual patients. Unlike contemporary approaches to hypertension management which are mainly population based, each participant patient in PHMA applies a unique intervention package and all messages, feedbacks and other materials sent out to individual patients are different from each other. PHMA is the first project that adopts comprehensive tailoring and if proved effective, it should have important implications for future research, practice and policy-making. Trial registration ISRCTN10999269. July 17, 2020; https://doi.org/10.1186/ISRCTN10999269 . [ABSTRACT FROM AUTHOR]

Background: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines, and lack of consideration of patients' preferences, thus highlighting the need for a more holistic and integrated approach to AF management.Objective: The objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care.Methods: This is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk.Results: There were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of 'ischemic stroke/systemic thromboembolism, death, and rehospitalization' were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05).Conclusions: An integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138). [ABSTRACT FROM AUTHOR]

Background: China's limited health care resources cannot meet the needs of chronic disease treatment and management of its rapid growing ageing population. The improvement and maintenance of patient's self-management is essential to disease management. Given disease management mainly occurs in the context of family, this study proposes to validate a Couple-based Collaborative Management Model of chronic diseases that integrates health professionals and family supporters; such as to empower the couples with disease management knowledge and skills, and to improve the couples' health and quality of life.Methods: The proposed study will validate a couple-based collaborative management model of Type 2 Diabetes Mellitus (T2DM) in a community-based multicenter, two-arm, randomized controlled trial of block design in Guangzhou, China. Specifically, 194 T2DM patients aged ≥55 and their partners recruited from community health care centers will be randomized at the patient level for each center at a 1:1 ratio into the couple-based intervention arm and the individual-based control arm. For the intervention arm, both the patients and their spouses will receive four-weekly structured group education & training sessions and 2 months of weekly tailored behavior change boosters; while these interventions will be only provided to the patients in the control group. Behavior change incentives will be targeted at the couples or only at the patient respectively. Treatment effects on patients' hemoglobin, spouses' quality of life, alongside couples' behavior outcomes will be compared between arms. Study implementation will be evaluated considering its Reach, Effectiveness, Adoption, Implementation and Maintenance following the RE-AIM framework.Discussion: This study will generate a model of effective collaboration between community health professionals and patients' family, which will shield light on chronic disease management strategy for the increasing ageing population.Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900027137, Registered 1st Nov. 2019. [ABSTRACT FROM AUTHOR]

Background: The system-integrated technology-enabled model of care (SINEMA) trial aimed to evaluate the effectiveness of a community-based multi-component intervention for secondary prevention of stroke in rural China. Objective: To present the detailed statistical analysis plan for the trial prior to database locking and data analysis. Methods: The detailed analysis plan outlines primary and secondary outcome measures, describes the over-arching data analysis principles to be adopted as well as more detailed descriptions of specific analytical approaches for effectiveness analyses, as well strategies to handle missing outcome data. Discussion: Publication of the statistical analysis plan increases the transparency of the data analysis procedure and reduces potential bias in trial reporting. Trial registration: The trial was registered with clinicaltrials.gov (NCT03185858). [ABSTRACT FROM AUTHOR]

Background Previous mass screening studies have shown that IgA antibodies against Epstein–Barr Virus (EBV) can facilitate early detection of nasopharyngeal carcinoma (NPC), but the impact of EBV-antibody screening for NPC-specific mortality remains unknown. Patients and methods A prospective, cluster randomized, controlled trial for NPC screening (PRO-NPC-001) was conducted in 3 selected towns of Zhongshan City and 13 selected towns of Sihui City in southern China beginning in 2008. Serum samples of the screening group were tested for two previously selected anti-EBV antibodies. Subjects with serological medium risk were subsequently retested annually for 3 years, and those with serological high risk were referred to otorhinolaryngologists for diagnostic check-up. An interim analysis was carried out to evaluate the primary end points of the NPC-specific mortality and the early diagnostic rate, and the secondary end point of the NPC incidence, through linkage with the database of Zhongshan City. Results Among 70 296 total subjects, 29 413 screened participants (41.8% of the total subjects) in the screening group and 50 636 in the control group, 153 (43.3 per 100 000 person-year), 62 (55.3 per 100 000 person-year) and 99 (33.1 per 100 000 person-year) NPC cases were identified. The early diagnostic rates of NPC were significantly higher in the participants (79.0%, P  < 0.0001) and the screening group (45.9%, P  < 0.0001) compared with the control group (20.6%). Although no differences were found between NPC-specific mortality of the screening group and the control group [relative risk (RR)= 0.82, 95% confidence interval (CI) 0.37–1.79], lower NPC-specific mortality was noticed among participants from the screening group versus the control group (RR = 0.22, 95% CI 0.09–0.49). Conclusion IgA antibodies against EBV can identify high-risk population and was effective in screening for early asymptomatic NPC. Although the mortality reduction was not significant in the primary end point, we noted encouraging evidence of a mortality reduction in screening participants in this interim analysis. Clinical trial number NCT00941538. [ABSTRACT FROM AUTHOR]

Purpose: The prevalence of hypertension continues to increase worldwide, raising an urgent need for novel and efficient methods for controlling hypertension. As the Internet and smartphones become more popular, their multiple functions and large user base make mobile health (mHealth) technology a potential tool for hypertension management. We aim to evaluate the use of mHealth technology to improve blood pressure and self-management behavior in people with hypertension and prehypertension. Intervention: The mHealth intervention measures include health education, behavior promotion, group chatting and long-term blood pressure monitoring hierarchically delivered via WeChat application among 242 participants. The frequency, intensity and content of the hierarchical intervention are determined based on the cardiovascular risk stratification of the intervention subjects. Study design: This cluster randomized controlled trial was carried out in two subdistricts in Guangzhou, China, among 492 smartphone users with hypertension or prehypertension, from August 2018 to September 2019. The intervention group received hierarchical intervention through WeChat for six months, while the control group received usual care in the community healthcare center during this period. Indicators are measured at three time points for each group, and a telephone follow-up is planned for two years after the intervention. The primary outcome is systolic blood pressure; secondary outcomes include BMI, CPAT score, improvements in behavior and diet, score of self-efficacy and self-management. Feasibility is evaluated by intervention participation. The cost-effectiveness is evaluated by ICER. Conclusion: This study aims to evaluate the effect of the WeChat-based hierarchical management mode on improving blood pressure and self-management behavior in population with hypertension and prehypertension, based on health-related knowledge, self-efficacy and medication adherence. If successful, the management mode will serve as a feasible, economical and efficient hypertension management mode suitable for the community. Clinical trial identifier: ChiCTR1900023002 [ABSTRACT FROM AUTHOR]

Purpose: Hypertension prevalence is mounting at a great pace in the People's Republic of China and poses a serious threat to health care systems. Medication nonadherence is one of the key factors in controlling high blood pressure. Our study uses two-arm cluster randomized controlled trial to investigate whether personal consultation by postgraduate pharmacy students and short message services (SMS) is effective in improving medication adherence and blood pressure control. Patients and methods: The trial will involve 384 treated patients in 8 community health care centers (CHCs). The 8 CHCs will be randomly assigned to intervention and control group in a ratio of 1:1. Patients in the intervention group will receive a personal consultation which identifies the barriers to medication adherence and SMS reminders which will be sent at 3-day intervals while patients in the control group will receive standard pharmaceutical care. Personal consultation by pharmacy students will be delivered at months 0 and 3. SMS messages will include educational information about normal blood pressure, complications of hypertension, salt intake, healthy diet, smoking cessation, regular exercise, weight control, antihypertensive medication schedule and treatment. Both groups will be followed for 6 months in order to compare their medication adherence and blood pressure at months 0, 3 and 6. The primary clinical outcome is the change in mean blood pressure and medication adherence measured at baseline, months 3 and 6. Secondary outcome is the proportion of patients reaching controlled blood pressure at months 3 and 6. Discussion: Pharmacy students led consultation will be conducted in the process of physical examination and SMS reminders which is at low cost, may be a feasible way to address the high prevalence of hypertension in the People's Republic of China. [ABSTRACT FROM AUTHOR]

Importance Myopia is a major public health concern worldwide, while outdoor time is indicated to be protective against the onset of myopia. Background: To describe the methodology and baseline data of the Shanghai Time Outside to Reduce Myopia (STORM) trial. Design A 2‐year, school‐based, prospective, cluster randomized trial. Participants: Children from grade I and II classes of 24 schools from eight districts in Shanghai, China, were randomized to either a control group, a test group I (40‐min outdoor time/day) or test group II (80‐min outdoor time/day). Methods: At baseline and annual intervals, cycloplegic autorefraction and axial length measurement will be performed. Time outdoors and light exposure will be monitored via parent/carer questionnaires and a wearable device. Main Outcome Measures: Spherical equivalent, prevalence of myopia and time outdoors in each group. Results: A total of 6295 eligible children (age 7.2 ± 0.7 y [6‐9 y]) were randomized to control (n = 2037), test group I (n = 2329) and test group II (n = 1929). At baseline, spherical equivalent was +0.98 ± 1.02D, +1.02 ± 1.02D and +1.00 ± 0.99D (P = 0.708), myopia prevalence was 8.9, 7.7 and 7.8% (P = 0.270) and time outdoors was 58.5 ± 35.8, 59.8 ± 34.7 and 58.5 ± 35.3 min/d (P = 0.886) for control, test groups I and II, respectively. Conclusions and Relevance: Myopia prevalence was high at nearly 8 to 9% in school children aged 7 years in Shanghai, China. The current trial will help evaluate if increased time outdoors has a role to play in reducing the incidence of myopia and/or slow the progression of myopia. [ABSTRACT FROM AUTHOR]

Objectives: The prevalence of and risk factors for IAD among different ethnicity groups was unknown. Our aim was to investigate the prevalence of and risk factors for IAD among Han, Uygur and Kazakh ethnicities in Xinjiang. China. Methods: In total, 14,618 adult participants (7,799 males and 6,819 females) were recruited from the Cardiovascular Risk Survey. A 4-stage stratified cluster random sampling method was used. The participants’ personal information and medical history were assessed by questionnaire. IAD was diagnosed by a noninvasive arteriosclerosis analyzer. Results: The prevalence of abnormal IAD among the general population was 14.3%, with 12.5% in the Han, 14.9% in the Uygur, and 16.4% in the Kazakh populations. The prevalence of abnormal IAD among the hypertensive population was 19.4%, with 17.0% in the Han, 18.1% in the Uygur, and 22.7% in the Kazakh populations. The prevalence of abnormal IAD increased with age (all P < 0.01) but was not significantly different between the genders (all P> 0.05). Multivariate logistic regression analysis showed that age more than 45 years, obesity and hypertriglyceridemia were significantly associated with a higher prevalence of IAD. There were different risk factors for abnormal IAD in different ethnicities. Middle or old age, obesity, ABI and diabetes mellitus were risk factors for the Han population, smoking was a risk factor in the Uygur population, and obesity and PAD were risk factors in the Kazakh population. Conclusion: The prevalence of abnormal IAD in the Kazakh participants was higher than that in the Han and Uygur populations among both the general population and the hypertensive population in Xinjiang, China. The main risk factors of IAD were age, obesity, and triglyceride levels. Different ethnicities had different kinds of risk factors for IAD. [ABSTRACT FROM AUTHOR]

Background Variations in care and outcomes by sex in patients with acute coronary syndrome (ACS) have been reported worldwide. The aims of this study are to describe ACS management according to sex in China and the effects of a quality improvement program in Chinese male and female ACS patients. Methods and results Clinical Pathways for Acute Coronary Syndromes - Phase 2 (CPACS-2) was a cluster randomized trial to test whether a clinical pathways-based intervention would improve ACS management in China. The study enrolled 15,141 hospitalized patients [4631 (30.6%) were women] from 75 hospitals throughout China between October 2007 and August 2010. The intervention included clinical pathway implementation and performance measurement using standardized indicators with 6 monthly audit-feedback cycles. Eight key performance indicators reflecting in hospital management of ACS were measured. After adjustment for differences in patient characteristics and comorbidities at presentation, women were significantly less likely to undergo coronary angiography when indicated (RR 0.88 [0.85 to 0.92], P < 0.001), less likely to receive guideline recommended medical therapies at discharge (RR 0.94 [0.91 to 0.98], P = 0.003) and more likely to be hospitalized for shorter (mean difference − 0.42 [− 0.73 to − 0.12] days, P = 0.007). However, in-hospital clinical outcomes did not differ by sex. There was no evidence of heterogeneity in the relative effects of the quality improvement initiative by sex. Conclusions Sex disparities were apparent in some key quality of care indicators for patients with suspected with ACS presenting to hospitals in China. The beneficial effect of the quality improvement program was consistent in women and men. Clinical trial registration http://www.anzctr.org.au/default.aspx . Unique identifier: ACTRN12609000491268. [ABSTRACT FROM AUTHOR]

Objectives To investigate whether the implementation of the Observational Pain Management Protocol (Protocol) can improve pain management for nursing home residents with dementia. Design A two-group, single-blinded, cluster-randomized controlled trial. Setting Seventeen nursing homes. Participants Hundred and twenty eight recruited residents with advanced dementia and pain-related diagnoses were allocated to either the control or the experimental conditions based on the randomized group allocated to their home. Interventions The Protocol, which includes assessing, interpreting, and verifying the participants' observed pain scores, initiating pain-relieving interventions according to the observed pain scores, and reassessment, was implemented in the experimental homes for 12 weeks to guide the pain management of the participants. Meanwhile, the control homes continued to employ their usual pain management strategies. Measurements These included the use of pain medications (measured by the Medication Quantification Scale) and non-pharmacological pain treatments in terms of types and frequency, as well as the participants' observational pain scores (assessed by Chinese-Pain Assessment IN Advanced Dementia). Results A significant increase in the frequency (95% CI: −0.13 to −0.09, P < .01) and type (95% CI: −0.05 to −0.02, P < .01) of non-pharmacological interventions used was seen in the experimental homes in comparison with the control homes. However, no statistically significant difference in the use of pain medications was observed. A significant reduction in the observational pain score (95% CI: −0.26 to −0.17, P < .001) was obtained only in the experimental home. Conclusion This study supports the view that the Protocol is of clinical utility in enhancing the use of non-pharmacological pain-relieving interventions among residents with advanced dementia, leading to a reduction in their observational pain-related behaviors. However, the Protocol did not have any effect on the use of pain medications. [ABSTRACT FROM AUTHOR]

Introduction: More than 80% of schistosomiasis patients in China live in the lake and marshland regions. The purpose of our study is to assess the effect of a comprehensive strategy to control transmission of Schistosoma japonicum in marshland regions. Methodology/Principal Findings: In a cluster randomized controlled trial, we implemented an integrated control strategy in twelve villages from 2009 through 2011 in Gong'an County, Hubei Province. The routine interventions included praziquantel chemotherapy and controlling snails, and were implemented in all villages. New interventions, mainly consisting of building fences to limit the grazing area for bovines, building safe pastures for grazing, improving the residents' health conditions and facilities, were only implemented in six intervention villages. Results showed that the rate of S. japonicum infection in humans, bovines, snails, cow dung and mice in the intervention group decreased from 3.41% in 2008 to 0.81% in 2011, 3.3% to none, 11 of 6,219 to none, 3.9% to none and 31.7% to 1.7%, respectively (P<0.001 for all comparisons). In contrast, there were no statistically significant reductions of S. japonicum infection in humans, bovines and snails from 2008 to 2011 in the control group (P>0.05 for all comparisons). Moreover, a generalized linear model showed that there was a higher infection risk in humans in the control group than in the intervention group (OR = 1.250, P = 0.001) and an overall significant downward trend in infection risk during the study period. Conclusions/Significance: The integrated control strategy, designed to reduce the role of bovines and humans as sources of S. japonicum infection, was highly effective in controlling the transmission of S. japonicum in marshland regions in China. Trial Registration: Chinese Clinical Trial Registry ChiCTR-PRC-12002405. Author Summary: More than 80% of schistosomiasis patients in China live in the lake and marshland regions. Hence, how to control transmission of Schistosoma japonicum in these regions is especially important. From 2009 through 2011, we implemented an integrated control strategy, designed to reduce the role of bovines and humans as sources of S. japonicum infection, in twelve villages Gong'an County of Hubei Province, which is located in typical marshland. After three years, the rate of S. japonicum infection in humans, bovines and snails significantly declined in the six intervention villages. In contrast, there was no significant decline in these indexes in the six control villages. Moreover, there was a higher infection risk in humans in the control group than the intervention group. Our study showed that the integrated control strategy was highly effective in controlling the transmission of S. japonicum in marshland regions of China. [ABSTRACT FROM AUTHOR]

Background There have been few reports of differential responses to nutrition interventions in women and children from poor households. Women from poor households have greater nutritional risks and are potentially a target group for programmes. We assessed the modifying effects of household wealth on responses to micronutrient supplements in pregnancy on newborn anthropometry and perinatal mortality.Methods A cluster randomized double-blind controlled trial conducted in two rural counties in northwestern China. All pregnant women in villages were randomly allocated from enrolment until delivery to daily supplementation with folic acid (control), iron/folic acid or multiple micronutrients (MMNs) with a recommended allowance of 15 vitamins and minerals. Wealth was based on a score from an inventory of household assets.Results In the pregnant women from the poorest one-third of the households, MMN supplements significantly increased birth weight by 68 g [95% confidence interval (CI) 4–131 g], reduced low birth weight by 60% [relative risks (RRs) 0.40, 95% CI 0.21–0.78] and tended to reduce early neonatal mortality by 52% (RR 0.48, 95% CI 0.17–1.36) compared with folic acid. Iron/folic acid significantly increased the duration of gestation by 0.41 weeks (95% CI 0.18–0.65), reduced pre-term birth by 45% (RR 0.55, 95% CI 0.32–0.93) and significantly reduced early neonatal mortality by 90% (RR 0.10, 95% CI 0.01–0.79) compared with folic acid. Iron/folic acid and MMN supplements had no significant effects in women from wealthier households.Conclusions In rural China, women from the poorest households had the largest perinatal outcome responses to micronutrient supplementation. In these women, standard iron/folic acid provided more protection for neonatal survival than MMN supplements. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has led to worldwide school closures, with millions of children confined to online learning at home. As a result, children may be susceptible to anxiety and digital eye strain, highlighting a need for population interventions. Objective: The objective of our study was to investigate whether a digital behavior change intervention aimed at promoting physical activity could reduce children's anxiety and digital eye strain while undergoing prolonged homeschooling during the COVID-19 pandemic. Methods: In this cluster randomized controlled trial, homeschooled grade 7 students at 12 middle schools in southern China were recruited through local schools and randomly assigned by the school to receive (1:1 allocation): (1) health education information promoting exercise and ocular relaxation, and access to a digital behavior change intervention, with live streaming and peer sharing of promoted activities (intervention), or (2) health education information only (control). The primary outcome was change in self-reported anxiety score. Secondary outcomes included change in self-reported eye strain and sleep quality. Results: On March 16, 2020, 1009 children were evaluated, and 954 (94.5%) eligible children of consenting families were included in the intention-to-treat analysis. Children in the intervention (n=485, 6 schools) and control (n=469, 6 schools) groups were aged 13.5 (SD 0.5) years, and 52.3% (n=499) were male. The assigned interventions were completed by 896 children (intervention: n=467, 96.3%; control: n=429, 91.5%). The 2-week change in square-root–transformed self-reported anxiety scores was greater in the intervention (–0.23, 95% CI –0.27 to –0.20) vs control group (0.12, 95% CI 0.09-0.16; unadjusted difference –0.36, 95% CI –0.63 to –0.08; P =.02). There was a significant reduction in square-root–transformed eye strain in the intervention group (–0.08, 95% CI –0.10 to 0.06) compared to controls (0.07, 95% CI 0.05-0.09; difference –0.15, 95% CI –0.26 to –0.03; P =.02). Change in sleep quality was similar between the two groups. Conclusions: This digital behavior change intervention reduced children's anxiety and eye strain during COVID-19–associated online schooling. Trial Registration: ClinicalTrials.gov NCT04309097; http://clinicaltrials.gov/ct2/show/NCT04309097 J Med Internet Res 2021;23(4):e24316 doi:10.2196/24316 [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease (CKD) is a significant public health concern. In patients with CKD, interventions that support disease self-management have shown to improve health status and quality of life. At the moment, the use of electronic health (eHealth) technology in self-management interventions is becoming more and more popular. Evidence suggests that eHealth-based self-management interventions can improve health-related outcomes of patients with CKD. However, knowledge of the implementation and effectiveness of such interventions in general, and in China in specific, is still limited. This study protocol aims to develop and tailor the evidence-based Dutch 'Medical Dashboard' eHealth self-management intervention for patients suffering from CKD in China and evaluate its implementation process and effectiveness.Methods: To develop and tailor a Medical Dashboard intervention for the Chinese context, we will use an Intervention Mapping (IM) approach. A literature review and mixed-method study will first be conducted to examine the needs, beliefs, perceptions of patients with CKD and care providers towards disease (self-management) and eHealth (self-management) interventions (IM step 1). Based on the results of step 1, we will specify outcomes, performance objectives, and determinants, select theory-based methods and practical strategies. Knowledge obtained from prior results and insights from stakeholders will be combined to tailor the core interventions components of the 'Medical Dashboard' self-management intervention to the Chinese context (IM step 2-5). Then, an intervention and implementation plan will be developed. Finally, a 9-month hybrid type 2 trial design will be employed to investigate the effectiveness of the intervention using a cluster randomized controlled trial with two parallel arms, and the implementation integrity (fidelity) and determinants of implementation (IM step 6).Discussion: Our study will result in the delivery of a culturally tailored, standardized eHealth self-management intervention for patients with CKD in China, which has the potential to optimize patients' self-management skills and improve health status and quality of life. Moreover, it will inform future research on the tailoring and translation of evidence-based eHealth self-management interventions in various contexts.Trial Registration: Clinicaltrials.gov NCT04212923 ; Registered December 30, 2019. [ABSTRACT FROM AUTHOR]

Background: Men who have sex with men (MSM) are an important HIV key population in China. However, HIV testing rates among MSM remain suboptimal. Digital crowdsourced media interventions may be a useful tool to reach this marginalized population. We define digital crowdsourced media as using social media, mobile phone applications, Internet, or other digital approaches to disseminate messages developed from crowdsourcing contests. The proposed cluster randomized controlled trial (RCT) study aims to assess the effectiveness of a digital crowdsourced intervention to increase HIV testing uptake and decrease risky sexual behaviors among Chinese MSM.Methods: A two-arm, cluster-randomized controlled trial will be implemented in eleven cities (ten clusters) in Shandong Province, China. Targeted study participants will be 250 MSM per arm and 50 participants per cluster. MSM who are 18 years old or above, live in the study city, have not been tested for HIV in the past 3 months, are not living with HIV or have never been tested for HIV, and are willing to provide informed consent will be enrolled. Participants will be recruited through banner advertisements on Blued, the largest gay dating app in China, and in-person at community-based organizations (CBOs). The intervention includes a series of crowdsourced intervention materials (24 images and four short videos about HIV testing and safe sexual behaviors) and HIV self-test services provided by the study team. The intervention was developed through a series of participatory crowdsourcing contests before this study. The self-test kits will be sent to the participants in the intervention group at the 2nd and 3rd follow-ups. Participants will be followed up quarterly during the 12-month period. The primary outcome will be self-reported HIV testing uptake at 12 months. Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma.Discussion: Innovative approaches to HIV testing among marginalized population are urgently needed. Through this cluster randomized controlled trial, we will evaluate the effectiveness of a digital crowdsourced intervention, improving HIV testing uptake among MSM and providing a resource in related public health fields.Trial Registration: ChiCTR1900024350 . Registered on 6 July 2019. [ABSTRACT FROM AUTHOR]

Background: The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population.Methods: The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m2), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m2 (routine dialysis group) and 5 ml/min/1.73 m2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods.Discussion: This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m2. With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial.Trial Registration: The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015. [ABSTRACT FROM AUTHOR]

Background: Treatment for drug-sensitive tuberculosis (TB) is taken for at least 6 months and problems with adherence are common. Therefore, there is substantial interest in the possible use of eHealth interventions to support patients to take their treatment. Electronic medication monitors have been shown to improve adherence to TB medication, but the impact on clinical outcomes is unknown. We aim to evaluate the impact of a medication monitor-based treatment strategy for drug-sensitive TB patients on a composite poor outcome measured over 18 months from start of TB treatment.Methods/design: We will conduct an open, pragmatic, cluster randomised superiority trial, with 24 counties/districts in three provinces in China, randomised 1:1 to implement the intervention or standard of care. Adults (aged ≥ 18 years) with a new episode of GeneXpert-positive and rifampicin-sensitive pulmonary TB, who plan to be in the study area for the next 18 months, and will receive daily fixed-dose combination tablets for 6 months of treatment are eligible. The intervention is centred around a medication monitor that holds a 1-month supply of medication and has three key functions: as an audio and visual reminder for patients to take their daily medication; reminds patients of upcoming monthly visit; and records date and time whenever the box is opened. At the monthly follow-up visit, the doctor downloads these data to generate a graphical display of the last month's adherence record for discussion with the patient and potentially to switch the patient to more intensive management. The primary outcome is a composite poor outcome measured over 18 months from start of TB treatment, defined as either of poor outcome at the end of treatment (death, treatment failure, or loss to follow-up) or subsequent recurrence (culture positive for TB at 12 or 18 months or re-starting TB treatment in the follow-up period). An economic evaluation will also be conducted as part of this study.Discussion: This trial will assess whether a medication monitor-based treatment strategy can improve clinical outcomes for TB patients. Several trials of other eHealth interventions for TB treatment are ongoing and are summarised in this paper. This trial will provide an important part of the emerging evidence base for the potential of eHealth to improve TB treatment outcomes.Trial Registration: This trial was registered with Current Controlled Trials (identifier: ISRCTN35812455 ). Registered on May 19, 2016. [ABSTRACT FROM AUTHOR]