Investigator(s)
| WHO Technical Officer |
Ravivarman LAKSHMANASAMY World Health Organization, Country Office, India Ravivarman LAKSHMANASAMY 
|
| Principal Investigator |
Rohit Bhatia All India Institute of Medical Sciences, New Delhi Rohit Bhatia
|
| Co-Investigator(s) |
SRIVASTAVA M V PADMA All India Institute of Medical Sciences, New Delhi SRIVASTAVA M V PADMA
|
Title(s) and abstract
| Scientific title | Effectiveness of Home Based Self-Monitoring of Blood Pressure in a Primary Care set-up of India. An Open Label Randomized Controlled Trial |
| Public title | Assessing usefulness of Blood pressure monitoring at home level |
| Background | Undetected hypertension, untreated hypertension and compliance to treatment are the major factors for morbidity and mortality due to Noncommunicable diseases. In a recent Cochrane review on screening methods for hypertension, the authors could not find any well conducted studies for inclusion into the review. In the author's words the conclusions were “There is an implicit assumption that early detection of hypertension through screening can reduce the burden of morbidity and mortality, but this assumption has not been tested in rigorous research studies. High-quality evidence from RCTs or programmatic evidence from NRCTs on the effectiveness and costs or harms of different screening strategies for hypertension (mass, targeted, or opportunistic) to reduce hypertension-related morbidity and mortality is lacking.” Home base blood pressure management (HBPM) is an effective way to detect and monitor hypertension, recommended by major guidelines. HBPM has many advantages over office blood pressure monitoring. Still, it is not much explored. Therefore, this study is to bring a novel intervention to ascertain the change of attitude and detection of hypertension by providing a BP appara |
| Objectives | Primary Objectives Part A: 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: 1. 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. 2. To assess the effectiveness of self-monitoring of blood pressure in adherence to the antihypertensive treatment in a community set-up of North India Secondary objectives (common to both parts) 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. Uptake of the intervention as assessed by frequency of BP monitoring in the eligible family members of recruited subjects and additional yield of new cases among all the households of the intervention arm, where the denominator will be the total number of household members. 4. To help integrate this intervention into the NCD and IHCI programs for long-term NCD goals. |
| Study Methods | Study design: Open-label, two-arm, randomized controlled trial. The study will be conducted in the villages served by the Ballabgarh Health and Demographic Surveillance System (HDSS) Two villages (one for Part A and other for B objective) will be selected from the 28 villages in the area by convenience sampling. Sample size was calculated for each objective separately and house to house screening will be conducted as per the inclusion and exclusion criteria to find eligible individuals. Selected individuals, as per the sample size calculated will be recruited and written informed consent will be taken before participation in the study. In part A healthy self reported non-hypertensive individuals will be recruited, who will then be randomized into intervention and control groups. In part B, patients with known HT will be recruited who will then be randomized into intervention and control groups. The intervention group involves home based monitoring and education, and the control group involves only education and counselling for monitoring the blood pressure. Blood pressure checking will be done by a standardized apparatus, with recommendations to do so at least twice a month. The recordings will be noted in a logbook assigned for the purpose. Educational videos, materials for cardiovascular diseases education will be provided to study participants. Society of Hypertension Practice guidelines for diagnosis of hypertension and Pill counts method and Medication adherence reporting scale will be used for adherence monitoring. The uptake of the intervention shall be assessed by the frequency of blood pressure measured during the three months period and recorded in the mobile app in both groups. |
| Expected outcomes and use of results | Primary outcome(s) Part A The incidence of new cases of hypertension that are identified during the 3 month follow-up between the intervention and control group. The measure of effect will be the relative risk of identification of new cases of hypertension. Part B 1. The primary outcome #1 of this trial will be the difference in SBP at 3 month follow-up between the intervention and control group. 2. The co-primary outcome #2 of this trial will be the rate of medication adherence at 3 month follow-up between the intervention and control group. Secondary outcomes: 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 also use the device to measure their blood pressure. Therefore, we propose to measure this additional yield of new cases among all the households of the intervention arm, where the denominator will be the total number of household members. 4. To help integrate this intervention into the NCD programs for long-term NCD goals. |
| Keywords | effectiveness, blood pressure monitoring, home based, randomized control trial |
Research Details
| Student research | No |
| Start Date | 01-Nov-2022 |
| End Date | 30-Nov-2023 |
| Key Implementing Institution | All India Institute of Medical Sciences, New Delhi |
| Multi-country research | No |
| Nationwide research | No |
| India | |
| Research Domain(s) | Non-communicable diseases & Healthy Lifestyles |
| Research field(s) | Non-communicable Disease |
| Involves human subjects | Yes |
| Intervention Evaluation Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Under Review |