Background
Self-monitoring of blood pressure has been shown to optimize the management of blood pressure in high-income settings, but there is less evidence from low-to-middle income countries. We designed a proof-of-concept pilot trial to assess the feasibility and acceptability of an intervention built around self-monitoring of blood pressure and health education, and to measure its association with reduced blood pressure among hypertensives. The study was conducted in Lebanon, a country where the management of hypertension presents challenges similar to those faced in countries of the Arab region and other middle-income countries.
Methods
We conducted a parallel two-arm pilot trial with a mixed-method approach to investigate the effect of the intervention on patient experience. Hypertensive patients (n = 80) were recruited at two primary and one tertiary health centers in Beirut, and were randomly allocated (1:1) to either an intervention group where patients received blood pressure devices, diaries and educational sessions, or a control group where patients received standard of care as practiced in their health centers. The main outcomes were feasibility (recruitment, retention and adherence), acceptability, and changes in systolic blood pressure. Quantitative and qualitative data were obtained at baseline and 6 weeks later.
Results
The recruitment rates for the study was 52% and retention was 95%. Most participants in the self-monitoring group (33/38) reported that the device was convenient and easy to use. Complete case analysis showed that blood pressure monitoring was associated with a greater reduction in systolic (-6.3 mmHg, 95%CI [-12.4; − 0.17]) and diastolic (-1.9 mmHg, 95%CI [-6.34; 2.58]) blood pressure in the self-monitoring group (n = 36) as compared to the standard of care group (n = 36). Improved knowledge of hypertension was also observed in the self-monitoring group. There were no adverse events related to study participation.
Conclusions
Self-monitoring is acceptable and feasible and has the potential to improve hypertension management. Our results should be further tested in trials with adequate statistical power and longer follow-up periods to examine the effectiveness of the intervention on blood pressure levels.
Trial Registration and funding:
Retrospectively Registered on April 3, 2020. ISRCTN 16450193. Funded by the Harvard Medical School Center for Global Health Delivery.