Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).

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.

A Sustainable Community-Based Model of Noncommunicable Disease Risk Factor Surveillance (Shraddha-Jagrithi Project): Protocol for a Cohort Study.

BACKGROUND: India 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. OBJECTIVE: This study aimed at assessing a sustainable, community-based surveillance model for NCDs with corporate support fully embedded in the public health system. METHODS: Frontline 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. RESULTS: The 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. CONCLUSIONS: Surveillance 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 REGISTRATION: Clinical Trial Registry India CTRI/2018/07/014856; https://tinyurl.com/4saydnxf. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27299.