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CTRI Number  CTRI/2026/03/106770 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 14/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral
Other (Specify) [Digital Technology (Stroke Riskometer)]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Promote India study using Stroke Riskometer app to improve health and reduce stroke risk in adults in five Indian states 
Scientific Title of Study   Cluster Randomised Community Study of Stroke Riskometer Based Lifestyle Intervention in 50,000 Adults (40-75 Years) Across Five Indian States for Stroke Risk Reduction at 12 Months 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PROMOTE INDIA  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Rajinder K Dhamija 
Designation  Director 
Affiliation  Institute of Human Behaviour and Allied Sciences 
Address  Institute of Human Behaviour and Allied Sciences, Tahirpur Road, Swami Dayanand Hospital Rd, Dilshad Garden, New Delhi

New Delhi
DELHI
110095
India 
Phone  919990886679  
Fax    
Email  dhamijark@gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Rajinder K Dhamija 
Designation  Director 
Affiliation  Institute of Human Behaviour and Allied Sciences 
Address  Institute of Human Behaviour and Allied Sciences, Tahirpur Road, Swami Dayanand Hospital Rd, Dilshad Garden, New Delhi

New Delhi
DELHI
110095
India 
Phone  919990886679  
Fax    
Email  dhamijark@gov.in  
 
Details of Contact Person
Public Query
 
Name  Prof Rajinder K Dhamija 
Designation  Director 
Affiliation  Institute of Human Behaviour and Allied Sciences 
Address  Institute of Human Behaviour and Allied Sciences, Tahirpur Road, Swami Dayanand Hospital Rd, Dilshad Garden, New Delhi

New Delhi
DELHI
110095
India 
Phone  919990886679  
Fax    
Email  dhamijark@gov.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research headquarters V Ramalingaswami Bhawan PO Box 4911 Ansari Nagar New Delhi 110029 India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raman Chauhan  Dr Rajendra Prasad Government Medical College  Tanda Hospital Rd, Pushp Vihar Colony, Kangra, Sadarpur, Himachal Pradesh 176002, India
Kangra
HIMACHAL PRADESH 
9418136936

drramanchauhan@rediffmail.com 
Prof Rajinder K Dhamija  Institute of Human Behaviour and Allied Sciences  Tahirpur Road, Swami Dayanand Hospital Rd, Dilshad Garden, New Delhi, Delhi 110095, India
New Delhi
DELHI 
9990886679

dhamijark@gov.in 
Prof Surekha Dabla  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences  Medical Road, Rohtak, Haryana 124001, India
Rohtak
HARYANA 
9416291276

surekhadabla@yahoo.co.in 
Prof Sylaja PN  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011, India
Thiruvananthapuram
KERALA 
9446566287

sylajapn@sctimst.ac.in 
Prof M Logaraj  SRM Medical College Hospital And Research Centre  Mahatma Gandhi Rd, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603211, India
Chennai
TAMIL NADU 
9443185347

logarajm@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IEC-IHBAS Institute of Human Behaviour and Allied Sciences, Delhi  Approved 
Institutional Ethics Committee, Dr RPGMC Kangra  Approved 
Institutional Ethics Committee, PGIMS, Rohtak  Approved 
Institutional Ethics Committee, SCTIMST, Thiruvananthapuram  Approved 
SRM Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stroke 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stroke Riskometer  Stroke Riskometer app-based digital lifestyle intervention in English, Hindi, Tamil, Malayalam and Punjabi with summaries provided in selected languages. Intervention frequency is baseline and 12 months with 6 months telephonic assessment. 
Comparator Agent  Usual care  Usual care involves no digital lifestyle intervention. Intervention frequency is baseline and 12 months only. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adults (40 - 75 years old) with any level of increased cardiovascular risk. 
 
ExclusionCriteria 
Details  Participants with a documented history of stroke, transient ischaemic attack, or major heart disease (myocardial infarction, angina, prior coronary intervention or peripheral occlusive disease), or who present with obvious clinical signs, such as acute onset of limb weakness, speech difficulty, facial droop, surgical cardiac scars, or use of assistive walking devices, will be excluded. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
- Mean change in systolic blood pressure with a target of 2.5 mmHg reduction
- Changes in Life Essentials 8 and Life Simple 7 scores with a target of more than equal to 0.1 point improvement of score 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
- Change in behavioural and physiological risk factors
- Digital engagement and lifestyle adherence
- Intervention feasibility and acceptability 
12 months 
 
Target Sample Size   Total Sample Size="15000"
Sample Size from India="15000" 
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   Phase 3 
Date of First Enrollment (India)   01/04/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Rationale: Stroke is a major cause of death and disability in India, often occurring in individuals with low to borderline cardiovascular disease (CVD) risk groups missed by current high-risk-focused strategies. Despite growing global evidence on digital lifestyle tools like the Stroke Riskometer, there is limited implementation evidence on their feasibility and effectiveness across all CVD risk levels in diverse Indian settings.

Novelty: This will be the first large-scale, community-based implementation study in India evaluating a validated digital tool (Stroke Riskometer) for primary stroke prevention in adults at any level of increased CVD risk. The approach integrates personalised risk assessment and lifestyle guidance into a scalable, digital-first model embedded within the public health system.

Objectives: To assess the effectiveness of a Stroke Riskometer-based digital lifestyle intervention in reducing systolic blood pressure and improving behavioural and physiological stroke risk indicators among 15,000 adults aged 40-75 years out of 50,000 screened across five Indian states.

Methods: A cluster-randomised, community-level implementation trial will be conducted across 20 clusters (4 per state), allocated in a 3:1 ratio to intervention and control. Health workers will deliver digital risk profiling, lifestyle counselling, and follow-up support. Outcomes will be evaluated at 12 months using LS7/LE8 scores, clinical data, and behavioural indicators.

Expected Outcome: The trial will generate critical evidence on the feasibility, scalability, and effectiveness of a digital lifestyle intervention within India’s public health system, with anticipated benefits extending to stroke and other major non-communicable diseases.

 
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