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BackgroundMobile health (mHealth) technologies hold great promise in improving the delivery of high-quality health care services. Yet, there has been little research so far applying mHealth technologies in the context of delivering stroke care in resource-limited rural regions. ObjectiveThis study aimed to introduce the design and development of an mHealth system targeting primary health care providers and to ascertain its feasibility in supporting the delivery of a System-Integrated techNology-Enabled Model of cAre (SINEMA) service for strengthening secondary prevention of stroke in rural China. MethodsThe SINEMA mHealth system was designed by a multidisciplinary team comprising public health researchers, neurologists, and information and communication technology experts. The iterative co-design and development of the mHealth system involved the following 5 steps: (1) assessing the needs of relevant end users through in-depth interviews of stakeholders, (2) designing the functional modules and evidence-based care content, (3) designing and building the system and user interface, (4) improving and enhancing the system through a 3-month pilot test in 4 villages, and (5) finalizing the system and deploying it in field trial, and finally, evaluating its feasibility through a survey of the dominant user group. ResultsFrom the in-depth interviews of 49 relevant stakeholders, we found that village doctors had limited capacity in caring for village-dwelling stroke patients in rural areas. Primary health care workers demonstrated real needs in receiving appropriate training and support from the mHealth system as well as great interests in using the mHealth technologies and tools. Using these findings, we designed a multifaceted mHealth system with 7 functional modules by following the iterative user-centered design and software development approach. The mHealth system, aimed at 3 different types of users (village doctors, town physicians, and county managers), was developed and utilized in a cluster-randomized controlled trial by 25 village doctors in a resource-limited county in rural China to manage 637 stroke patients between July 2017 and July 2018. In the end, a survey on the usability and functions of the mHealth system among village doctors (the dominant group of users, response rate=96%, 24/25) revealed that most of them were satisfied with the essential functions provided (71%) and were keen to continue using it (92%) after the study. ConclusionsThe mHealth system was feasible for assisting primary health care providers in rural China in delivering the SINEMA service on the secondary prevention of stroke. Further research and initiatives in scaling up the SINEMA approach and this mHealth system to other resource-limited regions in China and beyond will likely enhance the quality and accessibility of essential secondary prevention among stroke patients. ClinicalTrialClinicalTrials.gov NCT03185858; https://clinicaltrials.gov/ct2/show/NCT03185858 International Registered Report Identifier (IRRID)RR2-10.1016/j.ahj.2018.08.015

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 The SINEMA trial is registered at ClinicalTrials.gov NCT03185858., Author(s): Lijing L. Yan 1,2,3,4,5,*, Enying Gong 1,6, Wanbing Gu 1,7, Elizabeth L. Turner 2,8, John A. Gallis 2,8, Yun Zhou 9, Zixiao Li 9, Kara E. McCormack 8, Li-Qun [...]