Self-Monitoring of Blood Pressure in a Primary Care set-up of India: A Randomized Controlled Trial
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2023/02/049949
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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. Willingness to self-monitor BP at home or get BP examined in the nearby health center
4. Written informed consent
1. 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 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. <br/ ><br> <br/ ><br>Part B- <br/ ><br>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. <br/ ><br> <br/ ><br>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.Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 1. Uptake of the intervention as assessed by frequency of BP monitoring in the recruited subjects. <br/ ><br>Timepoint: 3 months;2. Any vascular event. Stroke, MI or death <br/ ><br>Timepoint: 3 months;3. Among the households of individuals who receive the intervention, there is a <br/ ><br>possibility that apart from the individual recruited in our study, other family members <br/ ><br>also use the device to measure their blood pressure. As a secondary outcome, we <br/ ><br>propose to measure this additional yield of new cases among all the households of the <br/ ><br>intervention arm, where the denominator will be the total number of household <br/ ><br>members.Timepoint: 3 months;To help integrate this intervention into the NCD and IHCI programs for long-term <br/ ><br>NCD goals. <br/ ><br>Timepoint: 6 months