CTRI Number |
CTRI/2023/02/049949 [Registered on: 22/02/2023] Trial Registered Prospectively |
Last Modified On: |
04/08/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening Behavioral |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Self-Monitoring of Blood Pressure in a Primary Care set-up of India: A Randomized Controlled Trial |
Scientific Title of Study
|
Effectiveness of Home Based Self-Monitoring of Blood Pressure in a Primary Care set-up of India: An Open Label Randomized Controlled Trial |
Trial Acronym |
EASE-BP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rohit Bhatia |
Designation |
Professor |
Affiliation |
AIIMS. New Delhi |
Address |
Room No 3. VI Floor,
Neurosciences Center,
Department of Neurology,
All India Institute of Medical Sciences, New Delhi
South West DELHI 110029 India |
Phone |
011-26546625 |
Fax |
|
Email |
rohitbhatia71@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rohit Bhatia |
Designation |
Professor |
Affiliation |
AIIMS. New Delhi |
Address |
Room No 3. VI Floor,
Neurosciences Center,
Department of Neurology,
All India Institute of Medical Sciences, New Delhi
South West DELHI 110029 India |
Phone |
011-26546625 |
Fax |
|
Email |
rohitbhatia71@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rohit Bhatia |
Designation |
Professor |
Affiliation |
AIIMS. New Delhi |
Address |
Room No 3. VI Floor,
Neurosciences Center,
Department of Neurology,
All India Institute of Medical Sciences, New Delhi
South West DELHI 110029 India |
Phone |
011-26546625 |
Fax |
|
Email |
rohitbhatia71@yahoo.com |
|
Source of Monetary or Material Support
|
World Health Organization |
|
Primary Sponsor
|
Name |
World Health Organization |
Address |
Regional Office for South-East Asia Capital.
Parsvnath Towers, Floor 6, New Delhi, India-110001 |
Type of Sponsor |
Other [United Nations Agency dedicated to global health and safety] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rohit Bhatia |
All India Institute of Medical Sciences |
Room No 3. VI Floor,
Department of Neurology,
Neurosciences Center South West DELHI |
9891267417
rohitbhatia71@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
All India Institute of Medical Sciences (AIIMS). New Delhi. Institution Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Self reported non hypertensives |
Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
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 assessed for accuracy and recommended by the International Society of Hypertension. The individual shall be trained to monitor blood pressure at home as per 2020 International Society of Hypertension Practice guidelines. Subjects will be advised to measure blood pressure at least twice a month. Each time they are measuring, BP from the site will be recorded in the logbook. They will be advised to maintain a logbook for BP recordings in a diary provided to them. The subjects will also be educated regarding primordial and primary prevention of hypertension and atherosclerotic cardiovascular diseases. |
Comparator Agent |
Only educational material on hypertension |
Subjects in the control arm will be educated regarding primordial and primary prevention of hypertension atherosclerotic cardiovascular diseases. They will be requested to get their blood pressure checked at least twice a month at the nearby sub-center or primary health center of the village. Each time they are measuring, BP from the site will be recorded in the logbook. As part of the study, calibrated BP apparatus shall be provided at those sub-centers at both villages. The individuals will be advised to maintain a logbook for BP recordings in a diary provided to them. |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
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 |
|
ExclusionCriteria |
Details |
1. Pregnancy, lactating or planning pregnancy during the trial
2. Denial of consent, unwilling to self-monitor
3. Inability to undertake self-monitoring |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
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. |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Uptake of the intervention as assessed by frequency of BP monitoring in the recruited subjects.
|
3 months |
2. Any vascular event. Stroke, MI or death
|
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. |
3 months |
To help integrate this intervention into the NCD and IHCI programs for long-term
NCD goals.
|
6 months |
|
Target Sample Size
|
Total Sample Size="732" Sample Size from India="732"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/03/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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 – 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. |