Effectiveness of home-based self-monitoring of blood pressure for hypertension detection in India (EASE-BP): an open-label, randomised controlled trial

Background Substantial gaps remain in the diagnosis and management of hypertension, the most common preventable risk factor for vascular disease. In India, undetected and uncontrolled hypertension remains a major challenge, and home-based self-monitoring of blood pressure (SMBP) might offer a promising approach for earlier detection. Here, in the first part (part A) of a two-part study, we aimed to assess the effectiveness of SMBP plus education in identifying new hypertension cases versus health centre visits plus education. Methods We conducted a randomised controlled trial in a single village in India (Dayalpur), among adults aged 30 years and older who self-reported no diagnosis of hypertension, were not receiving any medications for treatment of hypertension, and had no cardiac comorbidities. Eligible participants were randomly assigned (1:1) to either the intervention (digital blood pressure device for home-based SMBP plus health education and information booklet) or the control (advised to visit nearest health centre for blood pressure measurement plus health education and information booklet). All participants were provided with a logbook to record blood pressure measurements. Randomisation was performed using computer-generated non-stratified block sequence (block size of four); allocation concealment was done using serially numbered opaque envelopes; and participants and field staff were not masked to group assignment. The primary outcome was the detection of new hypertension cases defined based on 2020 International Society of Hypertension global hypertension practice guidelines during the 3-month follow-up. All randomly assigned participants were analysed via an intention-to-treat approach; participants without logbook blood pressure measurements were classified as not having newly detected hypertension. The trial is registered with the Clinical Trial Registry–India with reference number CTRI/2023/02/049949 and is completed. Findings Between April 15, 2023, and Aug 30, 2023, 662 households were screened for study inclusion and 238 were excluded, resulting in 424 households being enrolled in the study. One member per household was randomly assigned to the intervention group (n=212) or the control group (n=212). The mean age of participants was 45 years (SD 10); 230 (54%) were female and 194 (46%) were male. The data cutoff date for analysis was April 30, 2024. At 3 months, cumulative incidence of detected hypertension was 43% (92 of 212 participants) in the intervention group compared with 12% (25 of 212 participants) in the control group (p<0·0001). The study intervention showed greater likelihood of hypertension detection than the control (adjusted relative risk 4·0 [95% CI 2·7–5·9]; p<0·0001). Participants with high blood pressure were advised to seek care at the local health centre. One myocardial infarction event leading to death occurred in the intervention group and one death was reported in the control group due to an acute diarrhoeal illness. Interpretation Home-based SMBP in a rural community was feasible and well accepted. Integrating provision of validated blood pressure devices into the national non-communicable disease programmes is recommended and could help close the clinical gap in undiagnosed hypertension and reduce cardiovascular burden risk through earlier diagnosis and intervention. Future studies are needed to assess long-term outcomes, cost-effectiveness, and scalable implementation strategies. Funding World Health Organization Southeast Asia Regional Office.