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 Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 15,000
- Locations
- 5
- Primary Endpoint
- - Mean change in systolic blood pressure with a target of 2.5 mmHg reduction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •75 years old) with any level of increased cardiovascular risk.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
- Mean change in systolic blood pressure with a target of 2.5 mmHg reduction
Time Frame: 12 months
- Changes in Life Essentials 8 and Life Simple 7 scores with a target of more than equal to 0.1 point improvement of score
Time Frame: 12 months
Secondary Outcomes
- - Change in behavioural and physiological risk factors(- Digital engagement and lifestyle adherence)
Investigators
Prof Rajinder K Dhamija
Institute of Human Behaviour and Allied Sciences