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Background India contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers – Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers). Methods This will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities—one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist. Discussion To our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries. Trial Registration. ClinicalTrials.gov, NCT03700034, registered 9 Oct 2018, https://www.clinicaltrials.gov/ct2/show/NCT03700034 CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27

Background There is substantial interest in leveraging digital health technology to support hypertension management in low- and middle-income countries such as India. The potential for healthcare infrastructure and broader context to support such initiatives in India has not been examined. We evaluated existing healthcare infrastructure to support digital health interventions and examined epidemiologic, socioeconomic, and geographical contextual correlates of healthcare infrastructure in 544 districts covering 29 states and union territories across India. Methods The study was a cross-sectional analysis of India’s Fourth District Level Household and Facility Survey (DLHS-4; 2012–2014), the most up-to-date nationally representative district-level healthcare infrastructure data. Facilities were the unit of analysis, and analyses accounted for clustering within states. The main outcome was healthcare system infrastructural context to implement hypertension management programs. Domains included diagnostics (functional BP instrument), medications (anti-hypertensive medication in stock), essential clinical staff (e.g., staff nurse, medical officer, pharmacist), and IT specific infrastructure (regular power supply, internet connection, computer availability). Descriptive analysis was conducted for infrastructure indicators based on the Indian Public Health Standards, and logistic regression was conducted to estimate the association between epidemiologic and geographical context (exposures) and the composite measure of healthcare system. Results Data from 32,215 government facilities were analyzed. Among lowest-tier subcenters, 30% had some IT infrastructure, while at the highest-tier district hospitals, 92% possessed IT infrastructure. At mid-tier primary health centres and community health centres, IT infrastructure availability was 28 and 51%, respectively. For all but sub-centres, the availability of essential staff was lower than the availability of IT infrastructure. For all but district hospitals, higher levels of blood pressure, body mass index, and urban residents were correlated with more favorable infrastructure. By region, districts in Western India tended towards having the best prepared health facilities. Conclusions IT infrastructure to support digital health interventions is more frequently lacking at lower and mid-tier healthcare facilities compared with apex facilities in India. Gaps were generally larger for staffing than physical infrastructure, suggesting that beyond IT infrastructure, shortages in essential staff impose significant constraints to the adoption of digital health interventions. These data provide early benchmarks for state- and district-level planning.

Background The growing burden of hypertension and diabetes is one of the major public health challenges being faced by the health system in India. Clinical Decision Support Systems (CDSS) that assist with tailoring evidence-based management approaches combined with task-shifting from more specialized to less specialized providers may together enhance the impact of a program. We sought to integrate a technology “CDSS” and a strategy “Task-shifting” within the Government of India’s (GoI) Non-Communicable Diseases (NCD) System under the Comprehensive Primary Health Care (CPHC) initiative to enhance the program’s impact to address the growing burden of hypertension and diabetes in India. Methods We developed a model of care “I-TREC” entirely calibrated for implementation within the current health system across all facility types (Primary Health Centre, Community Health Centre, and District Hospital) in a block in Shaheed Bhagat Singh (SBS) Nagar district of Punjab, India. We undertook an academic-community partnership to incorporate the combination of a CDSS with task-shifting into the GoI CPHC-NCD system, a platform that assists healthcare providers to record patient information for routine NCD care. Academic partners developed clinical algorithms, a revised clinic workflow, and provider training modules with iterative collaboration and consultation with government and technology partners to incorporate CDSS within the existing system. Discussion The CDSS-enabled GoI CPHC-NCD system provides evidence-based recommendations for hypertension and diabetes; threshold-based prompts to assure referral mechanism across health facilities; integrated patient database, and care coordination through workflow management and dashboard alerts. To enable efficient implementation, modifications were made in the patient workflow and the fulcrum of the use of technology shifted from physician to nurse. Conclusion Designed to be applicable nationwide, the I-TREC model of care is being piloted in a block in the state of Punjab, India. Learnings from I-TREC will provide a roadmap to other public health experts to integrate and adapt their interventions at the national level. Trial registration CTRI/2020/01/022723.

Background: The burden of noncommunicable diseases and their risk factors has rapidly increased worldwide, including in India. Innovative management strategies with electronic decision support and task sharing have been assessed for hypertension, diabetes mellitus, and depression individually, but an integrated package for multiple chronic condition management in primary care has not been evaluated. Methods: In a prospective, multicenter, open-label, cluster-randomized controlled trial involving 40 community health centers, using hypertension and diabetes mellitus as entry points, we evaluated the effectiveness of mWellcare, an mHealth system consisting of electronic health record storage and an electronic decision support for the integrated management of 5 chronic conditions (hypertension, diabetes mellitus, current tobacco and alcohol use, and depression) versus enhanced usual care among patients with hypertension and diabetes mellitus in India. At trial end (12-month follow-up), using intention-to-treat analysis, we examined the mean difference between arms in change in systolic blood pressure and glycated hemoglobin as primary outcomes and fasting blood glucose, total cholesterol, predicted 10-year risk of cardiovascular disease, depression score, and proportions reporting tobacco and alcohol use as secondary outcomes. Mixed-effects regression models were used to account for clustering and other confounding variables. Results: Among 3698 enrolled participants across 40 clusters (mean age, 55.1 years; SD, 11 years; 55.2% men), 3324 completed the trial. There was no evidence of difference between the 2 arms for systolic blood pressure (Δ=−0.98; 95% CI, −4.64 to 2.67) and glycated hemoglobin (Δ=0.11; 95% CI, −0.24 to 0.45) even after adjustment of several key variables (adjusted differences for systolic blood pressure: – 0.31 [95% CI, −3.91 to 3.29]; for glycated hemoglobin: 0.08 [95% CI, −0.27 to 0.44]). The mean within-group changes in systolic blood pressure in mWellcare and enhanced usual care were −13.65 mm Hg versus −12.66 mm Hg, respectively, and for glycated hemoglobin were −0.48% and −0.58%, respectively. Similarly, there were no differences in the changes between the 2 groups for tobacco and alcohol use or other secondary outcomes. Conclusions: We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02480062.

ImportanceThere is substantial interest in leveraging digital health technology to support hypertension management in low- and middle-income countries such as India. The potential for healthcare infrastructure and broader context to support such initiatives in the public healthcare system in India has not been examined.ObjectiveWe evaluated existing healthcare infrastructure to support digital health interventions and examined epidemiologic, socioeconomic, and geographical contextual correlates of healthcare infrastructure in 544 districts covering 29 states and union territories across India.DesignCross-sectional analysis of India’s Fourth District Level Household and Facility Survey (DLHS-4; 2012-2014), the most up-to-date district-level healthcare infrastructure data. Facilities were the unit of analysis and analyses accounted for clustering within states.SettingNationally representative data of health facilities across India.ParticipantsThe target sample was all health facilities within the government healthcare system.ExposuresEpidemiologic, socioeconomic, and geographical context.Main Outcome(s) and Measure(s)Healthcare system infrastructural context to implement hypertension management programs. Domains included diagnostics (functional BP instrument) medications (anti-hypertensive medication in stock), essential clinical staff (e.g., staff nurse, medical officer, pharmacist), and IT specific infrastructure (regular power supply, internet connection, computer availability). Infrastructure indicators were based on the Indian Public Health Standards.ResultsData from 32,215 government facilities were analyzed. Among lowest-tier subcenters, 30% had some IT infrastructure, while at the highest-tier district hospitals, 92% possessed IT infrastructure. At mid-tier primary health centres and community health centres, IT infrastructure availability was 29% and 51%, respectively. For all but sub-centres, the availability of essential staff was lower than the availability of IT infrastructure. For all but district hospitals, higher levels of blood pressure, body mass index, and urban residents were correlated with more favorable infrastructure. By region, districts in Western India tended towards having the best prepared health facilities.Conclusions and RelevanceIT infrastructure to support digital health interventions is more frequently lacking at lower and mid-tier healthcare facilities compared with apex facilities in India. Gaps were generally larger for staffing than physical infrastructure, suggesting that beyond IT infrastructure, shortages in essential staff pose as significant constraints to the adoption of digital health interventions. These data provide early benchmarks for state- and district level planning.

Background Hypertension and diabetes are among the most common and deadly chronic conditions globally. In India, most adults with these conditions remain undiagnosed, untreated, or poorly treated and uncontrolled. Innovative and scalable approaches to deliver proven-effective strategies for medical and lifestyle management of these conditions are needed. Methods The overall goal of this implementation science study is to evaluate the Integrated Tracking, Referral, Electronic decision support, and Care coordination (I-TREC) program. I-TREC leverages information technology (IT) to manage hypertension and diabetes in adults aged ≥30 years across the hierarchy of Indian public healthcare facilities. The I-TREC program combines multiple evidence-based interventions: an electronic case record form (eCRF) to consolidate and track patient information and referrals across the publicly-funded healthcare system; an electronic clinical decision support system (CDSS) to assist clinicians to provide tailored guideline-based care to patients; a revised workflow to ensure coordinated care within and across facilities; and enhanced training for physicians and nurses regarding non-communicable disease (NCD) medical content and lifestyle management. The program will be implemented and evaluated in a predominantly rural district of Punjab, India. The evaluation will employ a quasi-experimental design with mixed methods data collection. Evaluation indicators assess changes in the continuum of care for hypertension and diabetes and are grounded in the Reach, Effectiveness, Adoption Implementation, and Maintenance (RE-AIM) framework. Data will be triangulated from multiple sources, including community surveys, health facility assessments, stakeholder interviews, and patient-level data from the I-TREC program’s electronic database. Discussion I-TREC consolidates previously proven strategies for improved management of hypertension and diabetes at single-levels of the healthcare system into a scalable model for coordinated care delivery across all levels of the healthcare system hierarchy. Findings have the potential to inform best practices to ultimately deliver quality public-sector hypertension and diabetes care across India. Trial registration The study is registered with Clinical Trials Registry of India (registration number CTRI/2020/01/022723). The study was registered prior to the launch of the intervention on 13 January 2020. The current version of protocol is version 2 dated 6 June 2018.

Background The proportion of patients with controlled hypertension ( 80%); difference in proportion of patients compliant to anti-hypertensive medication/s; cost-effectiveness of intervention versus enhanced care. All the outcomes will be assessed at 12 months. Discussion The study is expected to provide evidence on the effectiveness of NCC-led, EDSS-based hypertension management in India and can likely offer an exemplar for improving cardiovascular disease (CVD) management in India within the resource-constrained public healthcare system. Trial registration ClinicalTrials.gov, ID: NCT03164317). Registered retrospectively on 23 May 2017 (first patient enrolled on 6 April 2017) because the authors did not receive a response to their original registration submission (5 January 2017) to the Clinical Trial Registry – India (CTRI). Electronic supplementary material The online version of this article (10.1186/s13063-018-2813-2) contains supplementary material, which is available to authorized users.

IntroductionIndia has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled ‘m-Power Heart Project’ is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial’s process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research.Methods and analysisThe process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick’s model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelliet al’s framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc.Ethics and disseminationEthical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations.Trial registration numberNCT03164317; Pre-results.

This paper describes development of mhealth application "mWellcare" for the integrated management of hypertension and diabetes in public primary health care settings. mWellcare application was developed in four phases: identifying gaps in usual care; identifying components of intervention; developing intervention; evaluating acceptability and feasibility through pilot testing. Final version of mWellcare application is capable of computing personalized evidence-based management plan for hypertension, diabetes and co-morbid conditions (depression and alcohol use disorder).

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*. (DOCX 49 kb)

IntroductionRising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysismWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and disseminationThe study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.Trial registrationmWellcare trial is registered with Clinicaltrial.gov (Registration numberNCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

Introduction: Data are limited evaluating the association of socioeconomic position and cardiovascular disease risk factors in rural India, an area facing rapid economic changes. Hypothesis: We hypothesized that socioeconomic position is associated with the prevalence of abnormal cardiovascular disease risk factors in rural India. Methods: From 2013-2014, we performed multi-stage, representative, community-based sampling of the rural Solan district of Himachal Pradesh in India as part of a prospective, longitudinal cohort study enrolling 40,017 participants. We collected data on demographics, medical history, anthropometry, blood pressure, and laboratory studies. Using factor analysis for mixed data, we constructed a socioeconomic position index incorporating education, occupation, income, and household assets for each individual. We used multivariable logistic regression models adjusted for age and sex to evaluate the association between quintiles of the socioeconomic position index and cardiovascular disease risk factors. Results: Participants’ mean (SD) age was 42.7 (15.9) years, and 57% were women. Fifteen percent of participants were illiterate (n = 6081) and 24% were employed (n = 9502). The mean (SD) BMI was 22.3 (4.1) kg/m 2 . The mean (SD) systolic and diastolic blood pressures were 139.6 (21.8) mmHg and 84.3 (11.4) mmHg, respectively. After adjustment, individuals in the highest quintile of socioeconomic position index had 2.19 (95% CI 2.01, 2.38) higher odds of being overweight, 3.43 (95% CI 2.91, 4.04) higher odds of being obese, 2.45 (95% CI 2.16, 2.78) higher odds of having hypertension, and 1.62 (95% CI 1.44, 1.82) higher odds of having diabetes mellitus (Figure). Conclusion: We observed a direct, stepwise association between socioeconomic position and prevalence of abnormal cardiovascular risk factors in rural India. Primordial prevention strategies are needed for rural Indians, including those who experience increases in socioeconomic position, to improve cardiovascular health.

Background The high burden of undetected and undertreated hypertension and diabetes mellitus is a major health challenge worldwide. The mP ower Heart Project aimed to develop and test a feasible and scalable intervention for hypertension and diabetes mellitus by task‐sharing with the use of a mobile phone–based clinical decision support system at Community Health Centers in Himachal Pradesh, India. Methods and Results The development of the intervention and mobile phone–based clinical decision support system was carried out using mixed methods in five Community Health Centers. The intervention was subsequently evaluated using pre–post evaluation design. During intervention, a nurse care coordinator screened, examined, and entered patient parameters into mobile phone–based clinical decision support system to generate a prescription, which was vetted by a physician. The change in systolic blood pressure, diastolic blood pressure, and fasting plasma glucose ( FPG ) over 18 months of intervention was quantified using generalized estimating equations models. During intervention, 6797 participants were enrolled. Six thousand sixteen participants had hypertension (mean systolic blood pressure: 146.1 mm Hg, 95% CI : 145.7, 146.5; diastolic blood pressure: 89.52 mm Hg, 95% CI : 89.33, 89.72), of which 3152 (52%) subjects were newly detected. Similarly, 1516 participants had diabetes mellitus (mean FPG : 177.9 mg/dL, 95% CI : 175.8, 180.0), of which 450 (30%) subjects were newly detected. The changes in systolic blood pressure, diastolic blood pressure, and FPG observed at 18 months of follow‐up were −14.6 mm Hg (95% CI : −15.3, −13.8), −7.6 mm Hg ( CI : −8.0, −7.2), and −50.0 mg/dL (95% CI : −54.6, −45.5), respectively, and were statistically significant even after adjusting for age, sex, and Community Health Center. Conclusions A nurse‐facilitated, mobile phone–based clinical decision support system‐enabled intervention in primary care was associated with improvements in blood pressure and blood glucose control and has the potential to scale‐up in resource poor settings. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifiers: NCT 01794052. Clinical Trial Registry—India: CTRI /2013/02/003412.

BackgroundAlthough most Indians live in rural settings, data on cardiovascular disease risk factors in these groups are limited. We describe the association between socioeconomic position and cardiovascular disease risk factors in a large rural population in north India.MethodsWe performed representative, community-based sampling from 2013 to 2014 of Solan district in Himachal Pradesh. We used education, occupation, household income, and household assets as indicators of socioeconomic position. We used tobacco use, alcohol use, low physical activity, obesity, hypertension, and diabetes as risk factors for cardiovascular disease. We performed hierarchical multivariable logistic regression, adjusting for age, sex and clustering of the health sub-centers, to evaluate the cross-sectional association of socioeconomic position indicators and cardiovascular disease risk factors.ResultsAmong 38,457 participants, mean (SD) age was 42.7 (15.9) years, and 57% were women. The odds of tobacco use was lowest in participants with graduate school and above education (adjusted OR 0.11, 95% CI 0.09, 0.13), household income >15,000 INR (adjusted OR 0.35, 95% CI 0.29, 0.43), and highest quartile of assets (adjusted OR 0.28, 95% CI 0.24, 0.34) compared with other groups but not occupation (skilled worker adjusted OR 0.93, 95% CI 0.74, 1.16). Alcohol use was lower among individuals in the higher quartile of income (adjusted OR 0.75, 95% CI 0.64, 0.88) and assets (adjusted OR 0.70, 95% CI 0.59, 0.82). The odds of obesity was highest in participants with graduate school and above education (adjusted OR 2.33, 95% CI 1.85, 2.94), household income > 15,000 Indian rupees (adjusted OR 1.89, 95% CI 1.63, 2.19), and highest quartile of household assets (adjusted OR 2.87, 95% CI 2.39, 3.45). The odds of prevalent hypertension and diabetes were also generally higher among individuals with higher socioeconomic position.ConclusionsIndividuals with lower socioeconomic position in Himachal Pradesh were more likely to have abnormal behavioral risk factors, and individuals with higher socioeconomic position were more likely to have abnormal clinical risk factors.

Background: Appropriate strategies and key stakeholder engagement are the keys to successful implementation of new health care interventions. Objectives: The study sought to articulate the key strategies used for scaling up a research-based intervention, mPower Heart electronic Clinical Decision Support System (e-CDSS), for state-wide implementation at health facilities in Tripura. Methods: Multiple strategies were used for statewide implementation of mPower Heart e-CDSS at noncommunicable diseases clinics across the government health facilities in Tripura: formation of a technical coordination-cum-support unit, change management, enabling environment, adapting the intervention with user focus, and strengthening the Health Information System. Results: The effective delivery of a new health system intervention requires engagement at multiple levels including political leadership, health administrators, and health professionals, which can be achieved by forming a technical coordination-cum-support unit. It is important to specify the role and responsibilities of existing manpower and provide a structured training program. Enabling environment at health facilities (providing essential equipment, space and time, etc.) is also crucial. Successful implementation also requires that patients, health care providers, the health system, and leadership recognize the immediate and long-term benefits of the new intervention and have a buy-in in the intervention. With constant encouragement and nudge from administrative authorities and by using multiple strategies, 40 government health facilities adopted the mPower Heart e-CDSS. From its launch in May 2017 until November 20, 2018, a total of 100,810 eligible individuals were screened and enrolled, with 35,884 treated for hypertension, 9,698 for diabetes, and 5,527 for both hypertension and diabetes. Conclusions: Multiple strategies, based on implementation principles, are required for successful scaling up of research-based interventions. Highlights The strong support of the political and administrative leadership is a key to roll out the new intervention at the population level. The mPower Heart e-CDSS is a unique research-based intervention for integrated management of non-communicable diseases, having features and functionality to meet the requirements of the public health system of India. The mPower Heart e-CDSS has enabled uniform evidence-based treatment at government health facilities in Tripura and has introduced task-shifting with greater involvement of nurses in care delivery of non-communicable diseases. Publication of this research will be helpful for the implementation of the research-based intervention in low resource settings and will contribute to translation research in Low and Middle-Income Countries (LMICs).

Background: Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India. Innovative approaches such as clinical decision support (CDS) software could play a major role in improving the quality of hypertension/diabetes care in primary care settings. Objective: To describe the steps and processes in the development of mWellcare, a complex intervention based on mobile health (mHealth) technology. Methods: The Medical Research Council framework was used to develop mWellcare in four steps: (1) identify gaps in usual care through literature review and health facility assessments; (2) identify the components of the intervention through discussions and consultations with experts; (3) develop intervention (clinical algorithms and mHealth system); and (4) evaluate acceptability and feasibility through pilot testing in five community health centers. Results: Lack of evidence-based, integrated, and systematic management of chronic conditions were major gaps identified. Experts in information technology, clinical fields, and public health professionals identified intervention components to address these gaps. Thereafter, clinical algorithm contextualized to primary care settings were prepared and the mWellcare intervention was developed. During the 2-month pilot, 631 patients diagnosed with hypertension and/or diabetes were registered, with a follow-up rate of 36.2%. The major barrier was resistance to follow mWellcare recommended patient workflow, and to overcome it, we emphasized onsite training and orientation program to cover all health care team member in each CHC. Conclusion: A pilot-tested mWellcare intervention is an mHealth system with important components, i.e. integrated management of chronic conditions, evidence-based CDS, longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit, which will be used by nurses at primary health care settings in India. The effectiveness and cost-effectiveness of the intervention will be tested through a cluster randomized trial (trial registration number NCT02480062).

Background— In rural areas in China and India, the cardiovascular disease burden is high but economic and healthcare resources are limited. This study (the Simplified Cardiovascular Management Study [SimCard]) aims to develop and evaluate a simplified cardiovascular management program delivered by community health workers with the aid of a smartphone-based electronic decision support system. Methods and Results— The SimCard study was a yearlong cluster-randomized, controlled trial conducted in 47 villages (27 in China and 20 in India). Recruited for the study were 2086 individuals with high cardiovascular risk (aged ≥40 years with self-reported history of coronary heart disease, stroke, diabetes mellitus, and/or measured systolic blood pressure ≥160 mm Hg). Participants in the intervention villages were managed by community health workers through an Android-powered app on a monthly basis focusing on 2 medication use and 2 lifestyle modifications. In comparison with the control group, the intervention group had a 25.5% ( P P P =0.04). However, no significant changes were observed in the lifestyle factors. The intervention was culturally tailored, and country-specific results revealed important differences between the regions. Conclusions— The results indicate that the simplified cardiovascular management program improved quality of primary care and clinical outcomes in resource-poor settings in China and India. Larger trials in more places are needed to ascertain the potential impacts on mortality and morbidity outcomes. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01503814.