Effectiveness of a mHealth application on remote monitoring and self-management of persons with hypertension in a coastal taluk of Udupi district: A study protocol for a community-based Cluster Randomized trial.

Background: Hypertension is a significant risk factor for cardiovascular disease, contributing to global mortality and disability. Approximately 30% of Indian adults are diagnosed with hypertension. Evidence supports that self-monitoring and blood pressure self-management can lower systolic BP by an average of 3.2 mmHg. mHealth applications facilitate remote monitoring and self-management, yet existing applications in India lack customisation for user needs, limiting their usability. This study aims to develop and evaluate a novel, user-friendly mHealth application tailored to hypertensive individuals. Methods: This study follows an Agile development design, an iterative software development approach that allows continuous feedback and refinement. The research will be conducted in three phases over an anticipated duration of 48 months. Phase 1 (12 months) will involve in-depth interviews and focus group discussions to identify essential features for a customised Android-based mHealth application. Phase 2 (12 months) will involve developing the application using Android Studio following Agile principles. Phase 3 (18 months) will be a community-based cluster randomised trial conducted in 12 villages to evaluate the application's effectiveness. Villages will be randomised into intervention and control groups. Each group will include 118 participants. The intervention group will use the mHealth application, while the control group will follow the standard hypertension management regimen. Villages and participants will be selected based on specific criteria, including population size, availability of healthcare facilities, and smartphone accessibility among hypertensive patients. Results: In the proposed study, if the intervention is helpful, hypertension patients in the community can be encouraged to use the mHealth application. If found effective, this application is anticipated to improve hypertensive patients' health status, knowledge, and self-care approach.Registration: Clinical Trials Registry - India ( CTRI/2022/03/041544).