Effectiveness of Home-Based Self-monitoring of Blood Pressure in a Primary Care set-up of India (EASE-BP): Protocol for an Open-Label Randomized Controlled Trial.

Background and objectives: Rising hypertension from inadequate detection, noncompliance with treatment, and poor control presents a major public health challenge. Previously, adopting the strategy of self-monitoring of blood pressure (SMBP) showed better hypertension detection, control, and medication adherence. However, evidence from India is scarce. Here, we present the trial protocol for the effectiveness of SMBP intervention in hypertension detection, blood pressure (BP) control, and medication adherence in a primary care set-up.

Methods: EASE-BP is an open-label randomized trial in two distinct adult populations - part-A self-reported non-hypertensive population (total sample size: 400) and part-B known hypertensive population (total sample size: 332). The two populations will be sampled from two separate villages under the Ballabgarh Health and Demographic Surveillance System. In both the populations, participants randomized in the intervention arm will receive a validated electronic BP device and will be advised to self-monitor BP for at least twice a month (or more). Those in the control arm will be advised to monitor BP for at least twice a month (or more) at the nearby health center. Participants in both arms will receive education on hypertension and atherosclerotic disease. In addition, adult family members in the households of randomized participants will be encouraged to monitor their BP. All participants and family members will be instructed to maintain a log of BP recordings in a diary that will be provided to them. Data will be collected at baseline and then every month for three-months. The primary outcome in part-A will be the incidence of new cases of hypertension during 3 months follow-up and in part-B will be the difference in SBP and rate of medication adherence at 3 months follow-up. Secondary outcomes will include (1) uptake of the intervention, (2) any stroke, myocardial infarction, or death, (3) additional yield of new cases of hypertension among the family members, and (4) integrating the intervention into the national programs for long-term noncommunicable disease goals.

Conclusion: EASE-BP will help understand if SMBP improves hypertension detection, BP control, and medication adherence. Consequently, this will appraise policymakers on whether provision of BP instruments may be added to the national program for hypertension prevention and control.

Trial registry number: This trial was registered under Clinical Trial Registry - India with reference number CTRI/2023/02/049949.