| 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
|
|
|
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
|
|
|
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. |