| CTRI Number |
CTRI/2025/12/099926 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Family-Based Counselling for Reducing Non-Communicable Disease Risk Behaviours and Outcomes among Hypertension patients: A Randomized Controlled Trial in Urban Chandigarh. |
|
Scientific Title of Study
|
Effectiveness of Family-Based Counselling for Reducing Non-Communicable Disease Risk Behaviours and Outcomes among Hypertension patients: A Randomized Controlled Trial in Urban Chandigarh for a period of 6 months |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smriti Jain |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
PGIMER, Chandigarh
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9399817477 |
| Fax |
|
| Email |
jainsmriti1500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. JS Thakur |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
PGIMER, Chandigarh
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463602173 |
| Fax |
|
| Email |
jsthakur64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smriti Jain |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
PGIMER, Chandigarh
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9399817477 |
| Fax |
|
| Email |
jainsmriti1500@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER, Chandigarh |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JS Thakur |
UAAM Indira Colony |
UAAM Idira Colony, Chandigarh
Chandigarh
CHANDIGARH |
9463602173
jsthakur64@gmail.com |
| Dr Vineeth Rajgopal |
UAAM Sector 50 |
UAAM Sector 50, Chandigarh
Chandigarh
CHANDIGARH |
9447164767
drvineethrajagopal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh. Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
counselling |
Age and role appropriate counselling shall be provided to family members above the age of 18 years of age regarding NCD risk behaviors. |
| Comparator Agent |
Routine care at UAAM |
Routine care shall be provided at UAAM Indira Colony and Sector 50 Chandigarh |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Primary Hypertension |
|
| ExclusionCriteria |
| Details |
Terminally ill patients.
Patients with Secondary Hypertension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in physical activity, diet, mental health, tobacco, alchohol use andmedicine aherence among participants |
0 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in disease control status among participants
Change in behaviour determinants among family members |
0 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a two-arm randomized controlled trial conducted in peri-urban areas of Chandigarh to assess the effectiveness and feasibility of family-based counselling for hypertension management. Adults aged 30–69 years with diagnosed hypertension will be randomized to receive either structured family-based counselling or routine standard care, with a total sample of 120 participants followed for six months. The intervention focuses on key modifiable NCD risk factors including diet, physical activity, tobacco and alcohol use, stress management, and medication adherence, and involves adult family members through four counselling contacts. Baseline and endline assessments will measure changes in behavioural risk factors, medication adherence, and blood pressure control among participants, as well as risk behaviours among family members. Effectiveness will be evaluated through pre–post comparisons between intervention and control groups, while feasibility, acceptability, and relevance of implementing the intervention at the primary healthcare level will be assessed using validated questionnaires and qualitative methods. |