Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh through Digital Technology Supported Decentralized Primary Care: Study Methods and Baseline Results for an Hybrid Effectiveness-Implementation Trial (Preprint)

BACKGROUND Hypertension and diabetes are common interrelated chronic conditions. Awareness, diagnosis, treatment, and control rates of these conditions remain low, and access to quality care – particularly in rural areas – is a persistent challenge in many low- and middle-income countries (LMICs). Strengthening primary healthcare, including the use of digital tools, is essential to improve management of these chronic conditions. OBJECTIVE This study aims to assess the implementation and effectiveness of a multicomponent, decentralized primary care model in comparison with a digital health-only intervention and usual care in rural Bangladesh. METHODS The study employs a type 2 effectiveness-implementation hybrid design, using a three-arm quasi-experimental approach, comprising two intervention arms and one usual care comparison arm. The study is being conducted across three subdistricts from Dinajpur district, Rangpur division, northern Bangladesh. Primary outcomes include blood pressure and blood glucose control rates, assessed by population-based repeated cross-sectional surveys with independent samples, supplemented by facility-based prospective cohort data. Additionally, mixed methods process evaluation is being conducted to capture the quantity, fidelity, adaptations, reach, and context of the interventions. RESULTS The baseline community survey was conducted between January and March 2024, enrolling 6849 participants distributed across three arms: 2262 in usual care, 2287 in the digital only arm, and 2300 in the multicomponent intervention arm. Participants had a mean (SD) age of 56 (11) years with equal sex distribution (50% female). Educational attainment was low with 40% of participants having no formal schooling and only 12 % attaining secondary or higher education. The majority (92%) reported being either self-employed or homemakers. The baseline blood pressure control rate among all participants with hypertension was 10% overall, while the glycemic control rates among those with diabetes was 15%. Awareness and treatment rates for hypertension were 35% and 23%, respectively, compared to 61% and 34% for diabetes. CONCLUSIONS The study has been generating rich data on implementation strategy and effectiveness of a multi-component decentralized primary care intervention in rural Bangladesh. The findings will have important implications for improving noncommunicable disease management in similar low-resource settings across LMICs. CLINICALTRIAL ClinicalTrials.gov, NCT06258473. Registered on 06 February 2024.