| CTRI Number |
CTRI/2024/12/077947 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Behavioral interventions for improving hypertension control among adults in Andhra Pradesh |
|
Scientific Title of Study
|
Behavioural Science Strategies to Increase Hypertension Diagnosis and Treatment BETTER HEART study |
| Trial Acronym |
Better Heart |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil Tandon |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Endocrinology and Metabolism Room No 312 3rd Floor Biotechnology Block AIIMS Ansari Nagar New Delhi
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
01126593433 |
| Fax |
|
| Email |
nikhil_tandon@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil Tandon |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Endocrinology and Metabolism Room No 312 3rd Floor Biotechnology Block AIIMS Ansari Nagar New Delhi
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
01126593433 |
| Fax |
|
| Email |
nikhil_tandon@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Tandon |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Endocrinology and Metabolism Room No 312 3rd Floor Biotechnology Block AIIMS Ansari Nagar New Delhi
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
01126593433 |
| Fax |
|
| Email |
nikhil_tandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| National Heart Lung and Blood Institute of the National Institutes of Health, USA |
|
|
Primary Sponsor
|
| Name |
National Heart Lung and Blood Institute National Institutes of Health USA |
| Address |
10 Center Dr, Bethesda, MD 20814, United States |
| Type of Sponsor |
Other [International Governmental funding agency ] |
|
|
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 Nikhil Tandon |
villages in Anantapuramu district |
Andhra Pradesh
Anantapur
ANDHRA PRADESH |
011-26593433
nikhil_tandon@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi. |
Approved |
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi. |
Approved |
| NOC office of the Director of Health and Family Welfare and Mission Director, NHM, AP, Mangalagiri, Guntur district |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals aged ≥30 years
with elevated BP (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) measured at home by trained research assistants,
and no history of hypertension
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active comparator : Control arm |
Participants will receive basic counseling on the importance of seeking treatment for uncontrolled hypertension. |
| Intervention |
Better Heart |
To support the long-term health promotion goals of the study, we will provide basic hypertension counseling to participants in all study groups. Participants will be randomly assigned to a control group or one of three intervention groups.Using a factorial trial design, participants will be randomized to receive (1) standard hypertension counseling or enhanced hypertension counseling; and (2) no financial
incentives or a financial incentive for clinic-based confirmatory screening for hypertension. The total duration of the study will be roughly two years based on the anticipated time required to enroll participants and the 6-month follow-up duration for each participants.
Each participant will be enrolled in the study for about 6 months. At baseline, we will visit participants at their home and administer a baseline questionnaire and conduct a blood pressure measurement. Those with elevated blood pressure will be referred to the nearest PHC for confirmatory testing within 3 months. We will administer a questionnaire at the PHC to particpants who seek confirmatory testing. Finally, at 6 months, we will contact participants at their home and administer a brief questionnaire and conduct blood pressure measurement again.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
For the randomized trial, we will enroll individuals who meet the following inclusion criteria: Age ≥30 years, elevated BP (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) measured at home by trained research assistants, and no prior physician diagnosis of hypertension (self-reported). We have chosen to focus on those aged ≥30 years as this is the official age cutoff used for home-based and opportunistic hypertension screening in India. |
|
| ExclusionCriteria |
| Details |
We will exclude individuals who meet the following criteria: Self-reported prior history of stroke or myocardial infarction, alcohol abuse, drug abuse, self-reported hyperthyroidism, and self-reported kidney disease.
There will be no exclusions based on sex or gender. Since hypertension may affect any person regardless of their sex/gender, it is important that study participants are recruited irrespective of their sex or gender.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be assessed at 3 months. The primary outcome will be the receipt of confirmatory blood pressure measurement from a physician at a PHC. This is a binary variable that will be assessed by study staff members based at each PHC. As noted above, the staff will be tasked with recording whether study participants attended the PHC in the three months after enrollment. |
baseline;12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be assessed at 6 months. About 6 months from enrolment, the study team will schedule an appointment with participants to ask them some additional questions & measure their blood pressure again. The secondary outcome is an indicator of whether the participant received treatment & had controlled BP (140/90 mmHg) at 6 months. This will be assessed during the 6-month follow-up visit. |
baseline, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="1700"
Sample Size from India="1700"
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)
|
01/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Elevated
blood pressure is a leading risk factor for mortality worldwide, yet much of
this mortality is preventable through early diagnosis and sustained use of
available treatments. Low and middle-income countries face a disproportionate
burden of hypertension, as they account for over 80% of people living with
hypertension. Increasing the diagnosis, treatment, and control of hypertension
is therefore essential for improving health outcomes. In the world’s largest
country, India, hypertension prevalence among adults remains high and a vast
majority of those with hypertension are undiagnosed or not receiving care. This
project will utilize insights from behavioral science to address important
barriers to clinic-based confirmatory blood pressure measurement and linkage to
hypertension care. The project will test behavioral strategies that help
individuals form correct beliefs about the need for treatment and that offset
the costs associated with care-seeking. Building on our expertise in behavioral
science research and our extensive prior work in India, the Behavioral Science
Strategies to Increase Hypertension Diagnosis and Treatment (BETTER HEART)
study will use a randomized controlled trial with a factorial design to
determine the effectiveness of two promising and scalable behavioral science
strategies to increase uptake of clinic-based hypertension care in Andhra
Pradesh, India.
Specific
aims of the project are as follows. Aim 1: Adapt and refine promising
user-centered strategies for promoting clinic-based confirmatory blood pressure
measurement for the Indian context using participatory prototyping and survey
experiments. Aim 2: Determine the effectiveness of enhanced hypertension
counseling and financial incentives for increasing clinic-based confirmatory
blood pressure measurement. Aim 3: Conduct a qualitative evaluation to
contextualize the effectiveness data and inform future implementation of
strategies on a larger scale. Findings from this
study will strengthen our understanding of how to adapt behavioral science
strategies to local settings and advance the scientific evidence on behavioral
strategies to address the growing burden of
hypertension in India and other LMICs. |