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Abstract Background Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication. Methods The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4–5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done. Discussion The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment. Trial registration The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.

BackgroundIndia has a massive noncommunicable disease (NCD) burden, at an enormous cost to the individual, family, society, and health system at large, despite which prevention and surveillance are relatively neglected. If diagnosed early and treated adequately, risk factors for atherosclerotic cardiovascular disease would help decrease the mortality and morbidity burden. Surveillance for NCDs, creating awareness, positive lifestyle changes, and treatment are the proven measures known to prevent the progression of the disease. India is in a stage of rapid epidemiological transition, with the state of Kerala being at the forefront, pointing us towards likely disease burden and outcomes for the rest of the country in the future. A previous study done by the same investigators in a population of >100,000 revealed poor awareness, treatment of NCDs, and poor adherence to medicines in individuals with CVD. ObjectiveThis study aimed at assessing a sustainable, community-based surveillance model for NCDs with corporate support fully embedded in the public health system. MethodsFrontline health workers will check all individuals in the target group (≥age 30 years) with further follow-up and treatment planned in a “spoke and hub” model using the public health system of primary health centers as spokes to the hubs of taluk or district hospitals. All data entry done by frontline health workers will be on a tablet PC, ensuring rapid acquisition and transfer of participant health details to primary health centers for further follow-up and treatment. ResultsThe model will be evaluated based on the utilization rate of various services offered at all tier levels. The proportions of the target population screened, eligible individuals who reached the spoke or hub centers for risk stratification and care, and community-level control for hypertension and diabetes in annual surveys will be used as indicator variables. The model ensures diagnosis and follow-up treatment at no cost to the individual entirely through the tiered public health system of the state and country. ConclusionsSurveillance for NCDs is an essential facet of health care presently lacking in India. Atherosclerotic cardiovascular disease has a long gestation period in progression to the symptomatic phase of the disease, during which timely preventive and lifestyle measures would help prevent disease progression if implemented. Unfortunately, several asymptomatic individuals have never tested their plasma glucose, serum lipid levels, or blood pressure and are unaware of their disease status. Our model, implemented through the public health system using frontline health workers, would ensure individuals aged≥30 years at risk of disease are identified, and necessary lifestyle modifications and treatments are given. In addition, the surveillance at the community level would help create a general awareness of NCDs and lead to healthier lifestyle habits. Trial RegistrationClinical Trial Registry India CTRI/2018/07/014856; https://tinyurl.com/4saydnxf International Registered Report Identifier (IRRID)DERR1-10.2196/27299

Introduction: Hypertension is the leading risk factor for global disease burden. Inequalities in health among urban poor and non-poor is a matter of concern. The current study was done to estimate the prevalence of hypertension and to describe the health seeking and risk factor profile of people with hypertension in the urban slums of Kochi, Kerala, India. Methods: Blood pressure of 5980 adults from 20 randomly selected slums were measured by door to door survey by trained nurses as a part of baseline assessment for a cluster randomised controlled trial. Results: Prevalence of hypertension was found to be 34.8% (95% CI 33.5–34.9). Among those with hypertension, 66.9% were aware of their hypertensive status, of which 75.8% were initiated on treatment for hypertension. Proportion of hypertensive in the population who had their blood pressure under control was 24.5%. Among hypertensive, 53% were obese, 25.1% had diabetes mellitus, 14% had history of hospitalisation for high blood pressure. Of them, 60.3% had a per capita salt consumption above 8 g/day and 47.5% of them reported sitting for more than 8 h on a usual day. Mean monthly out of pocket expenditure for treatment of hypertension was $9(Median $8, IQR $16). Conclusion: One in three adults in urban slums of Kochi had hypertension. High rates of obesity, salt intake, physical inactivity prevails among the people with hypertension. Awareness, treatment initiation and control rate of hypertension are lower in urban slums as compared to non-slum urban areas. Slums require additional attention to ensure equitable and universal access to hypertension control.

Background With less than 20% of people with hypertension achieving their target blood pressure (BP) goals, uncontrolled hypertension remains a major public health problem in India. We conducted a study to assess the effectiveness of a community-based education and peer support programme led by women’s self-help group (SHG) members in reducing the mean systolic BP among people with hypertension in urban slums of Kochi city, Kerala, India.Methods A cluster randomised controlled pragmatic trial was conducted where 20 slums were randomised to either the intervention or the control arms. In each slum, participants who had elevated BP (>140/90) or were on antihypertensive medications were recruited. The intervention was delivered through women’s SHG members (1 per 20–30 households) who provided (1) assistance in daily hypertension management, (2) social and emotional support to encourage healthy behaviours and (3) referral to the primary healthcare system. Those in the control arm received standard of care. The primary outcome was change in mean systolic BP (SBP) after 6 months.Results A total of 1952 participants were recruited—968 in the intervention arm and 984 in the control arm. Mean SBP was reduced by 6.26 mm Hg (SE 0.69) in the intervention arm compared with 2.16 mm Hg (SE 0.70) in the control arm; the net difference being 4.09 (95% CI 2.15 to 4.09), p

The coexistence of raised blood pressure (BP) in people with type 2 diabetes mellitus (T2DM) is a major contributor to the development and progression of both macrovascular and microvascular complications. The aim of our study was to determine the prevalence of uncontrolled BP and its associated factors in persons with T2DM in a district in Kerala.MethodsThe study was conducted in Ernakulam district in Kerala, and a total of 3,092 individuals with T2DM were enrolled after obtaining consent. Those with a BP “above or equal to 140 mmHg” and/or “above or equal to 90 mmHg” were thus considered to have uncontrolled BP. If the BP was equal or >140 and/or 90 mmHg, a repeat reading was taken after 30 min and the average of the two was considered. Basic demographic details were enquired along with electronic measurement of BP, HbA1c estimation and screening for diabetic retinopathy, peripheral arterial disease (PAD), and peripheral neuropathy. Quantitative and qualitative variables were expressed as mean (SD) and proportions, respectively. The model for determinants of uncontrolled BP was developed adjusting for age, gender, education, duration of diabetes, occupation, body mass index (BMI) and clustering effect.ResultsThe mean age of the study population was 59.51 ± 9.84 years. The mean duration of T2DM was found to be 11.3 ± 6.64 years. The proportion of uncontrolled HTN adjusted for clustering was 60% (95% CI 58 and 62%). Among them, only one in two persons (53.3%) had a history of hypertension. Age >60 years [adjusted odds ratio (aOR) 1.48, 95% CI 1.24, 1.76; p < 0.001], unemployment (aOR 1.33, 95% CI 1.01, 1.75; p < 0.01), duration of diabetes > 11 years (aOR 1.42, 95% CI 1.19, 1.68; p < 0.001), and BMI ≥23 (aOR 1.33, 95% CI 1.10, 1.59; p < 0.002) were found to be independent determinants of high BP levels when adjusted for the aforementioned variables, gender, education, and cluster effect. The association between complications, such as peripheral neuropathy, PAD, and retinopathy showed a higher risk among those with uncontrolled BP. Retinopathy was 1.35 times more (95% CI 1.02, 1.7, p < 0.03), PAD was 1.6 times more (95% CI 1.2, 2.07, p < 0.001), and peripheral neuropathy was 1.5 (95% CI 1.14, 1.9, p < 0.003) times more compared to their counterparts.ConclusionTarget BP levels were far from being achieved in a good majority of the persons with T2DM. To reduce further macrovascular and microvascular events among people with T2DM, effective awareness and more stringent screening measures need to be employed in this population.