Skip to content

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

Effectiveness of Home Based Self-Monitoring of Blood Pressure in a Primary Care set-up of India: An Open Label Randomized Controlled Trial - EASE-BP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049949
Enrollment
732
Registered
2023-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Home-based blood pressure device along with educational material on hypertension: In the intervention arm, each subject will be given a validated electronic BP device that has been asse

Sponsors

World Health Organization
Lead Sponsor

Eligibility

Inclusion criteria

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. Willingness to self-monitor BP at home or get BP examined in the nearby health center 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactating or planning pregnancy during the trial 2. Denial of consent, unwilling to self-monitor 3. Inability to undertake self-monitoring

Design outcomes

Primary

MeasureTime frame
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. Part B- 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. 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

MeasureTime frame
1. Uptake of the intervention as assessed by frequency of BP monitoring in the recruited subjects. Timepoint: 3 months;2. Any vascular event. Stroke, MI or death Timepoint: 3 months;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. As a secondary outcome, 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.Timepoint: 3 months;To help integrate this intervention into the NCD and IHCI programs for long-term NCD goals. Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Rohit Bhatia

AIIMS. New Delhi

rohitbhatia71@yahoo.com011-26546625

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026