Self-Monitoring of Blood Pressure in a Primary Care set-up of India: A Randomized Controlled Trial

Not yet recruiting

Conditions: Essential (primary) hypertension,
Self reported non hypertensives

Registration Number: CTRI/2023/02/049949

Lead Sponsor: World Health Organization

Brief Summary: Hypertension is a major culprit for cardiovascular morbidity and mortality. The prevalence of hypertension in India is around 25% and studies have shown 12% incidence of hypertension in the younger population (18-25 years) of the country. There is still a significant gap in detection and treatment of hypertension. In low-income countries like India, screening for early detection of hypertension and monitoring is the most effective way to prevent mortality and morbidity. One of the targets of 25 by 25 set by the NCD program of India is to reduce the prevalence of high BP by 25% by 2025. Despite the availability of information on hypertension and regular monitoring of blood pressure, people tend not to do that. Hence, we hypothesize that availability of a blood pressure measuring device at the home will lead to increased detection of hypertension, better control of BP, adherence to treatment and frequency of monitoring of BP among those individuals compared to those who do not have the same at home, while education is provided to both the groups. Based on this hypothesis, the primary objectives include two parts:

Part A: Objective #1 - To assess the effectiveness of self-monitoring of blood pressure in identifying new hypertensive cases among those with no hypertension in a community set-up of North India.

Part B: Objective #2 - To assess the effectiveness of self-monitoring of blood pressure in controlling blood pressure among patients with hypertension in a community set-up of North India. Objective #3 - To assess the effectiveness of self-monitoring of blood pressure in adherence to the antihypertensive treatment in a community set-up of North India.

The study design is an open-label, two-arm, randomized controlled trial and will be conducted in two populations â€“ self-reported non-hypertensive healthy individuals and known hypertensive individuals. This study will be implemented in a community setting in rural area of North India, specifically in the villages served by the Ballabgarh Health Demographic Surveillance System (HDSS). This HDSS has two PHCs viz Dayalpur and Chhainsa that provide services to 28 villages. Through a convenience sampling, two villages will be selected, one village for Part A and the other for Part B. Potentially eligible individuals will be identified through a house-to-house survey at select villages, following inclusion and exclusion criteria. All the eligible individuals will be listed household-wise to recruit only one individual per household. Randomization will be done using this list. Sample size was calculated for each primary objectives: In Part A, objective #1 will have 400 individuals with no hypertension (200 in each arm); In part B, objective #2 will have 332 individuals (166 in each arm) and in objective #3 will have 325 (162 in each arm). In both Part A and B, recruited individuals will be randomized to either intervention arm (i.e., home-based self-BP monitoring and education) or the control arm (only education and advice for BP monitoring at health centre) using a computer-based system. The intervention arm will be given a validated electronic BP device and will be trained to monitor BP at home. The participants will also be given educational booklet regarding hypertension prevention and atherosclerotic cardiovascular disease outcome. In the control arm, the same educational booklet will be provided, and they will be requested to get their BP checked at least twice a month at the nearby sub-centre or primary health centre. Each time they go and measure their BP, it will be recorded in the logbook. The trial period is for 3 months after which outcome assessments will be done. By the end of the study, the primary outcome in Part A would be identification of new cases of hypertensive individuals, in Part B objective #2 would be the difference in SBP at 3 months follow-up between the intervention group and control group, and in Part B objective #3 would be the rate of medication adherence at 3 months follow-up between the intervention group and control group. The outcome of the secondary objectives would be intervention uptake, any vascular events (Stroke, MI or death), additional yield of new hypertensive cases among all the households of the intervention arm, and integrating this intervention into the NCD and IHCI programs for long-term NCD goals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 732

Inclusion Criteria

PART A Non-hypertensive population 1.
Age 30 years and above 2.
Self-reported NO history of hypertension 3.
Not on any medications for treatment of hypertension currently or previously 4.
No cardiovascular comorbidity 5.
Willingness to self-monitor BP at home or get BP examined in the nearby health center 6.
Written informed consent PART B Hypertensive population 1.
Age 18 years and above 2.
Diagnosed as having hypertension previously by a physician or currently on anti-hypertensive medication 3.
Written informed consent.

Exclusion Criteria

Pregnancy, lactating or planning pregnancy during the trial 2.
Denial of consent, unwilling to self-monitor 3.
Inability to undertake self-monitoring.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. The co-primary outcome #2 of this trial will be the rate of medication adherence at 3 month follow-up between the intervention group and control group.	3 months
Part A- The primary outcome of this trial will be the incidence of new cases of hypertension that are identified during the 3 month follow-up between the intervention group and control group. The measure of effect will be the relative risk of identification of new cases of hypertension.	3 months
Part B-	3 months
1. The primary outcome #1 of this trial will be the difference in SBP at 3 month follow-up between the intervention group and control group.	3 months

Secondary Outcome Measures

Name	Time	Method
1. Uptake of the intervention as assessed by frequency of BP monitoring in the recruited subjects.
2. Any vascular event. Stroke, MI or death
3. Among the households of individuals who receive the intervention, there is a	possibility that apart from the individual recruited in our study, other family members
To help integrate this intervention into the NCD and IHCI programs for long-term	NCD goals.

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
West, DELHI, India
All India Institute of Medical Sciences
🇮🇳West, DELHI, India
Dr Rohit Bhatia
Principal investigator
9891267417
rohitbhatia71@yahoo.com