More People, More Active, More Often for Heart Health - Taking Action on Physical Activity.

Physical inactivity is a leading contributor to increased cardiovascular morbidity and mortality. Almost 500 million new cases of preventable noncommunicable diseases (NCDs) will occur globally between 2020 and 2030 due to physical inactivity, costing just over US$300 billion, or around US$ 27 billion annually (WHO 2022). Active adults can achieve a reduction of up to 35% in risk of death from cardiovascular disease. Physical activity also helps in moderating cardiovascular disease risk factors such as high blood pressure, unhealthy weight and type 2 diabetes. For people with cardiovascular disease, hypertension, type 2 diabetes and many cancers, physical activity is an established and evidence-based part of treatment and management. For children and young people, physical activity affords important health benefits. Physical activity can also achieve important cross-sector goals. Increased walking and cycling can reduce journeys by vehicles, air pollution, and traffic congestion and contribute to increased safety and liveability in cities.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Air pollution, physical activity and health: A mapping review of the evidence.

BACKGROUND: Exposure to air pollution and physical inactivity are both significant risk factors for non-communicable diseases (NCDs). These risk factors are also linked so that the change in exposure in one will impact risks and benefits of the other. These links are well captured in the active transport (walking, cycling) health impact models, in which the increases in active transport leading to increased inhaled dose of air pollution. However, these links are more complex and go beyond the active transport research field. Hence, in this study, we aimed to summarize the empirical evidence on the links between air pollution and physical activity, and their combined effect on individual and population health. OBJECTIVES AND METHODS: We conducted a non-systematic mapping review of empirical and modelling evidence of the possible links between exposure to air pollution and physical activity published until Autumn 2019. We reviewed empirical evidence for the (i) impact of exposure to air pollution on physical activity behaviour, (ii) exposure to air pollution while engaged in physical activity and (iii) the short-term and (iv) long-term health effects of air pollution exposure on people engaged in physical activity. In addition, we reviewed (v) public health modelling studies that have quantified the combined effect of air pollution and physical activity. These broad research areas were identified through expert discussions, including two public events performed in health-related conferences. RESULTS AND DISCUSSION: The current literature suggests that air pollution may decrease physical activity levels during high air pollution episodes or may prevent people from engaging in physical activity overall in highly polluted environments. Several studies have estimated fine particulate matter (PM2.5) exposure in active transport environment in Europe and North-America, but the concentration in other regions, places for physical activity and for other air pollutants are poorly understood. Observational epidemiological studies provide some evidence for a possible interaction between air pollution and physical activity for acute health outcomes, while results for long-term effects are mixed with several studies suggesting small diminishing health gains from physical activity due to exposure to air pollution for long-term outcomes. Public health modelling studies have estimated that in most situations benefits of physical activity outweigh the risks of air pollution, at least in the active transport environment. However, overall evidence on all examined links is weak for low- and middle-income countries, for sensitive subpopulations (children, elderly, pregnant women, people with pre-existing conditions), and for indoor air pollution. CONCLUSIONS: Physical activity and air pollution are linked through multiple mechanisms, and these relations could have important implications for public health, especially in locations with high air pollution concentrations. Overall, this review calls for international collaboration between air pollution and physical activity research fields to strengthen the evidence base on the links between both and on how policy options could potentially reduce risks and maximise health benefits.

Built environment for physical activity-An urban barometer, surveillance, and monitoring.

The Lancet Commission on Obesity (LCO), also known as the "syndemic commission," states that radical changes are required to harness the common drivers of "obesity, undernutrition, and climate change." Urban design, land use, and the built environment are few such drivers. Holding individuals responsible for obesity detracts from the obesogenic built environments. Pedestrian priority and dignity, wide pavements with tree canopies, water fountains with potable water, benches for the elderly at regular intervals, access to open-green spaces within 0.5-km radius and playgrounds in schools are required. Facilities for physical activity at worksite, prioritization of staircases and ramps in building construction, redistribution of land use, and access to quality, adequate capacity, comfortable, and well-networked public transport, which are elderly and differently abled sensitive with universal design are some of the interventions that require urgent implementation and monitoring. An urban barometer consisting of valid relevant indicators aligned to the sustainable development goals (SDGs), UN-Habitat-3 and healthy cities, should be considered a basic human right and ought to be mounted for purposes of surveillance and monitoring. A "Framework Convention on Built Environment and Physical Activity" needs to be taken up by WHO and the UN for uptake and implementation by member countries.

Effect of workplace physical activity interventions on the cardio-metabolic health of working adults: systematic review and meta-analysis.

BACKGROUND: Adults in urban areas spend almost 77% of their waking time being inactive at workplaces, which leaves little time for physical activity. The aim of this systematic review and meta-analysis was to synthesize evidence for the effect of workplace physical activity interventions on the cardio-metabolic health markers (body weight, waist circumference, body mass index (BMI), blood pressure, lipids and blood glucose) among working adults. METHODS: All experimental studies up to March 2018, reporting cardio-metabolic worksite intervention outcomes among adult employees were identified from PUBMED, EMBASE, COCHRANE CENTRAL, CINAHL and PsycINFO. The Cochrane Risk of Bias tool was used to assess bias in studies. All studies were assessed qualitatively and meta-analysis was done where possible. Forest plots were generated for pooled estimates of each study outcome. RESULTS: A total of 33 studies met the eligibility criteria and 24 were included in the meta-analysis. Multi-component workplace interventions significantly reduced body weight (16 studies; mean diff: - 2.61 kg, 95% CI: - 3.89 to - 1.33) BMI (19 studies, mean diff: - 0.42 kg/m2, 95% CI: - 0.69 to - 0.15) and waist circumference (13 studies; mean diff: - 1.92 cm, 95% CI: - 3.25 to - 0.60). Reduction in blood pressure, lipids and blood glucose was not statistically significant. CONCLUSIONS: Workplace interventions significantly reduced body weight, BMI and waist circumference. Non-significant results for biochemical markers could be due to them being secondary outcomes in most studies. Intervention acceptability and adherence, follow-up duration and exploring non-RCT designs are factors that need attention in future research. Prospero registration number: CRD42018094436.

Patient and healthcare provider knowledge, attitudes and barriers to handover and healthcare communication during chronic disease inpatient care in India: a qualitative exploratory study.

OBJECTIVES: 1) To investigate patient and healthcare provider (HCP) knowledge, attitudes and barriers to handover and healthcare communication during inpatient care. 2) To explore potential interventions for improving the storage and transfer of healthcare information. DESIGN: Qualitative study comprising 41 semi-structured, individual interviews and a thematic analysis using the Framework Method with analyst triangulation. SETTING: Three public hospitals in Himachal Pradesh and Kerala, India. PARTICIPANTS: Participants included 20 male (n=10) and female (n=10) patients with chronic non-communicable disease (NCD) and 21 male (n=15) and female (n=6) HCPs. Purposive sampling was used to identify patients with chronic NCDs (cardiovascular disease, chronic respiratory disease, diabetes or hypertension) and HCPs. RESULTS: Patient themes were (1) public healthcare service characteristics, (2) HCP to patient communication and (3) attitudes regarding medical information. HCP themes were (1) system factors, (2) information exchange practices and (3) quality improvement strategies. Both patients and HCPs recognised public healthcare constraints that increased pressure on hospitals and subsequently limited consultation times. Systemic issues reported by HCPs were a lack of formal handover systems, training and accessible hospital-based records. Healthcare management communication during admission was inconsistent and lacked patient-centredness, evidenced by varying reports of patient information received and some dissatisfaction with lifestyle advice. HCPs reported that the duty of writing discharge notes was passed from senior doctors to interns or nurses during busy periods. A nurse reported providing predominantly verbal discharge instructions to patients. Patient-held medical documents facilitated information exchange between HCPs, but doctors reported that they were not always transported. HCPs and patients expressed positive views towards the idea of introducing patient-held booklets to improve the organisation and transfer of medical documents. CONCLUSIONS: Handover and healthcare communication during chronic NCD inpatient care is currently suboptimal. Structured information exchange systems and HCP training are required to improve continuity and safety of care during critical transitions such as referral and discharge. Our findings suggest that patient-held booklets may also assist in enhancing handover and patient-centred practices.

Facilitators and barriers of heart failure care in Kerala, India: A qualitative analysis of health-care providers and administrators.

OBJECTIVE: Heart failure is a leading cause of death worldwide and in India, yet the qualitative data regarding heart failure care are limited. To fill this gap, we studied the facilitators and barriers of heart failure care in Kerala, India. METHODS AND RESULTS: During January 2018, we conducted a qualitative study using in-depth, semi-structured interviews with 21 health-care providers and quality administrators from 8 hospitals in Kerala to understand the context, facilitators, and barriers of heart failure care. We developed a theoretical framework using iteratively developed codes from these data to identify 6 key themes of heart failure care in Kerala: (1) need for comprehensive patient and family education on heart failure; (2) gaps between guideline-directed clinical care for heart failure and clinical practice; (3) national hospital accreditation contributing to a culture of systematically improving quality and safety of in-hospital care; (4) limited system-level attention toward improving heart failure care compared with other cardiovascular conditions; (5) application of existing personnel and technology to improve heart failure care; and (6) longitudinal and recurrent costs as barriers for optimal heart failure care. CONCLUSIONS: Key themes emerged regarding heart failure care in Kerala in the context of a health system that is increasingly emphasizing health-care quality and safety. Targeted in-hospital quality improvement interventions for heart failure should account for these themes to improve cardiovascular outcomes in the region.

The Public Health Leadership and Implementation Academy for Noncommunicable Diseases.

PURPOSE AND OBJECTIVES: Low- and middle-income countries (LMICs) have a large burden of noncommunicable diseases and confront leadership capacity challenges and gaps in implementation of proven interventions. To address these issues, we designed the Public Health Leadership and Implementation Academy (PH-LEADER) for noncommunicable diseases. The objective of this program evaluation was to assess the quality and effectiveness of PH-LEADER. INTERVENTION APPROACH: PH-LEADER was directed at midcareer public health professionals, researchers, and government public health workers from LMICs who were involved in prevention and control of noncommunicable diseases. The 1-year program focused on building implementation research and leadership capacity to address noncommunicable diseases and included 3 complementary components: a 2-month online preparation period, a 2-week summer course in the United States, and a 9-month, in-country, mentored project. EVALUATION METHODS: Four trainee groups participated from 2013 through 2016. We collected demographic information on all trainees and monitored project and program outputs. Among the 2015 and 2016 trainees, we assessed program satisfaction and pre-post program changes in leadership practices and the perceived competence of trainees for performing implementation research. RESULTS: Ninety professionals (mean age 38.8 years; 57% male) from 12 countries were trained over 4 years. Of these trainees, 50% were from India and 29% from Mexico. Trainees developed 53 projects and 9 publications. Among 2015 and 2016 trainees who completed evaluation surveys (n = 46 of 55), we saw pre-post training improvements in the frequency with which they acted as role models (Cohen's d = 0.62, P <.001), inspired a shared vision (d = 0.43, P =.005), challenged current processes (d = 0.60, P <.001), enabled others to act (d = 0.51, P =.001), and encouraged others by recognizing or celebrating their contributions and accomplishments (d = 0.49, P =.002). Through short on-site evaluation forms (scale of 1-10), trainees rated summer course sessions as useful (mean, 7.5; SD = 0.2), with very good content (mean, 8.5; SD = 0.6) and delivered by very good professors (mean, 8.6; SD = 0.6), though they highlighted areas for improvement. IMPLICATIONS FOR PUBLIC HEALTH: The PH-LEADER program is a promising strategy to build implementation research and leadership capacity to address noncommunicable diseases in LMICs.

Implementation and acceptability of a heart attack quality improvement intervention in India: a mixed methods analysis of the ACS QUIK trial.

BACKGROUND: The ACS QUIK trial showed that a multicomponent quality improvement toolkit intervention resulted in improvements in processes of care for patients with acute myocardial infarction in Kerala but did not improve clinical outcomes in the context of background improvements in care. We describe the development of the ACS QUIK intervention and evaluate its implementation, acceptability, and sustainability. METHODS: We performed a mixed methods process evaluation alongside a cluster randomized, stepped-wedge trial in Kerala, India. The ACS QUIK intervention aimed to reduce the rate of major adverse cardiovascular events at 30 days compared with usual care across 63 hospitals (n = 21,374 patients). The ACS QUIK toolkit intervention, consisting of audit and feedback report, admission and discharge checklists, patient education materials, and guidelines for the development of code and rapid response teams, was developed based on formative qualitative research in Kerala and from systematic reviews. After four or more months of the center's participation in the toolkit intervention phase of the trial, an online survey and physician interviews were administered. Physician interviews focused on evaluating the implementation and acceptability of the toolkit intervention. A framework analysis of transcripts incorporated context and intervening mechanisms. RESULTS: Among 63 participating hospitals, 22 physicians (35%) completed online surveys. Of these, 17 (77%) respondents reported that their hospital had a cardiovascular quality improvement team, 18 (82%) respondents reported having read an audit report, admission checklist, or discharge checklist, and 19 (86%) respondents reported using patient education materials. Among the 28 interviewees (44%), facilitators of toolkit intervention implementation were physicians' support and leadership, hospital administrators' support, ease-of-use of checklists and patient education materials, and availability of training opportunities for staff. Barriers that influenced the implementation or acceptability of the toolkit intervention for physicians included time and staff constraints, Internet access, patient volume, and inadequate understanding of the quality improvement toolkit intervention. CONCLUSIONS: Implementation and acceptability of the ACS QUIK toolkit intervention were enhanced by hospital-level management support, physician and team support, and usefulness of checklists and patient education materials. Wider and longer-term use of the toolkit intervention and its expansion to potentially other cardiovascular conditions or other locations where the quality of care is not as high as in the ACS QUIK trial may be useful for improving acute cardiovascular care in Kerala and beyond. TRIAL REGISTRATION: NCT02256657.

Physical activity, sitting, and risk factors of cardiovascular disease: a cross-sectional analysis of the CARRS study.

We aimed to estimate the associations between substituting 30-min/day of walking or moderate-to-vigorous physical activity (MVPA) for 30 min/day of sitting and cardiovascular risk factors in a South Asian population free of cardiovascular disease. We collected information regarding sitting and physical activity from a representative sample of 6991 participants aged 20 years and above from New Delhi, India and Karachi, Pakistan enrolled in 2010-2011 in the Center for cArdio-metabolic Risk Reduction in South Asia study using the International Physical Activity Questionnaire (short form). We conducted isotemporal substitution analyses using multivariable linear regression models to examine the cross-sectional associations between substituting MVPA and walking for sitting with cardiovascular risk factors. Substituting 30 min/day of MVPA for 30 min/day of sitting was associated with 0.08 mmHg lower diastolic blood pressure (ß = -0.08 [- 0.15, - 0.0003]) and 0.13 mg/dl higher high-density lipoprotein cholesterol (ß = 0.13 [0.04, 0.22]). Substituting 30 min/day of walking for 30 min/day of sitting was associated with 0.08 kg/m2 lower body mass index (ß = -0.08 [- 0.15, - 0.02]), and 0.25 cm lower waist circumference (ß = -0.25 [- 0.39, - 0.11]). In conclusion, substituting time engaged in more-active pursuits for time engaged in less-active pursuits was associated with modest but favorable cardiovascular risk factor improvements among South Asians.

Tobacco Cessation Among Acute Coronary Syndrome Patients in Kerala, India: Patient and Provider Perspectives.

Tobacco cessation is an important intervention to reduce mortality from ischemic heart disease, the leading cause of death in India. In this study, we explored facilitators, barriers, and cultural context to tobacco cessation among acute coronary syndrome (ACS, or heart attack) patients and providers in a tertiary care institution in the south Indian state of Kerala, with a focus on patient trajectories. Patients who quit tobacco after ACS expressed greater understanding about the link between tobacco and ACS, exerted more willpower at the time of discharge, and held less fatalistic beliefs about their health compared to those who continued tobacco use. The former were motivated by the fear of recurrent ACS, strong advice to quit from providers, and determination to survive and financially provide for their families. Systemic barriers included inadequate training, infrequent prescription of cessation pharmacotherapy, lack of ancillary staff to deliver counseling, and stigma against mental health services.

Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial.

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.

Investigating clinical handover and healthcare communication for outpatients with chronic disease in India: A mixed-methods study.

OBJECTIVES: Research concentrating on continuity of care for chronic, non-communicable disease (NCD) patients in resource-constrained settings is currently limited and focusses on inpatients. Outpatient care requires attention as this is where NCD patients often seek treatment and optimal handover of information is essential. We investigated handover, healthcare communication and barriers to continuity of care for chronic NCD outpatients in India. We also explored potential interventions for improving storage and exchange of healthcare information. METHODS: A mixed-methods design was used across five healthcare facilities in Kerala and Himachal Pradesh states. Questionnaires from 513 outpatients with cardiovascular disease, chronic respiratory disease, or diabetes covered the form and comprehensiveness of information exchange between healthcare professionals (HCPs) and between HCPs and patients. Semi-structured interviews with outpatients and HCPs explored handover, healthcare communication and intervention ideas. Barriers to continuity of care were identified through triangulation of all data sources. RESULTS: Almost half (46%) of patients self-referred to hospital outpatient clinics (OPCs). Patient-held healthcare information was often poorly recorded on unstructured sheets of paper; 24% of OPC documents contained the following: diagnosis, medication, long-term care and follow-up information. Just 55% of patients recalled receiving verbal follow-up and medication instructions during OPC appointments. Qualitative themes included patient preference for hospital visits, system factors, inconsistent doctor-patient communication and attitudes towards medical documents. Barriers were hospital time constraints, inconsistent referral practices and absences of OPC medical record-keeping, structured patient-held medical documents and clinical handover training. Patients and HCPs were in favour of the introduction of patient-held booklets for storing and transporting medical documents. CONCLUSIONS: Deficiencies in communicative practices are compromising the continuity of chronic NCD outpatient care. Targeted systems-based interventions are urgently required to improve information provision and exchange. Our findings indicate that well-designed patient-held booklets are likely to be an acceptable, affordable and effective part of the solution.

Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings.

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).

Incidence & prevalence of stroke in India: A systematic review.

BACKGROUND & OBJECTIVES: There has been more than 100 per cent increase in incidence of stroke in low- and middle-income countries including India from 1970-1979 to 2000-2008. Lack of reliable reporting mechanisms, heterogeneity in methodology, study population, and small sample size in existing epidemiological studies, make an accurate estimation of stroke burden in India challenging. We conducted a systematic review of epidemiologic studies on stroke conducted in India to document the magnitude of stroke. METHODS: All population-based, cross-sectional studies and cohort studies from India which reported the stroke incidence rate or cumulative stroke incidence and/or the prevalence of stroke in participants from any age group were included. Electronic databases (Ovid, PubMed, Medline, Embase and IndMED) were searched and studies published during 1960 to 2015 were included. A total of 3079 independent titles were identified for screening, of which 10 population-based cross-sectional studies were considered eligible for inclusion. Given the heterogeneity of the studies, meta-analysis was not carried out. RESULTS: The cumulative incidence of stroke ranged from 105 to 152/100,000 persons per year, and the crude prevalence of stroke ranged from 44.29 to 559/100,000 persons in different parts of the country during the past decade. These values were higher than those of high-income countries. INTERPRETATION & CONCLUSIONS: A paucity of good-quality epidemiological studies on stroke in India emphasizes the need for a coordinated effort at both the State and national level to study the burden of stroke in India. Future investment in the population-based epidemiological studies on stroke would lead to better preventive measures against stroke and better rehabilitation measures for stroke-related disabilities in the country.

Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India.

INTRODUCTION: Rising 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 ANALYSIS: mWellcare 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 DISSEMINATION: The 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 REGISTRATION: mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; 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).