A Family Based Randomized Controlled Trial of Cardiovascular Risk Reduction in Individuals With Family History of Premature Coronary Heart Disease in India
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,678
- Locations
- 1
- Primary Endpoint
- Composite outcome of multiple cardiovascular risk factors
Study Overview
Brief Summary
The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in individuals with family history of premature coronary heart disease (CHD).
This care model involves:
- screening for cardiovascular risk factors,
- providing lifestyle interventions for prevention and management of cardiovascular risk factors,
- providing a framework for linkage to appropriate primary health care facility and
- active follow-up of intervention adherence.
Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package (for example, context specific ways to enhance physical activity and to reduce prolonged sitting time, ways to improve diet etc.) and feedback on the intervention strategies (lifestyle education, care and linkage coordination). Then a randomized controlled trial involving ~700 families and 1400 participants will be used to determine whether an integrated care model is effective in reducing or halting the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic and qualitative lenses to estimate value and acceptability. Scalability will be informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.
Detailed Description
STUDY AIMS:
AIM 1. To identify barriers to implementing an integrated cardiovascular risk management program in families of individuals with a positive history CHD.
AIM 2. To assess the effectiveness of an integrated cardiovascular risk management strategy (consisting of screening for risk factors, lifestyle education and linkage to primary care for cardiovascular risk factor management) on risk factor clustering in families, and changes in blood pressure (BP), lipids, glucose, smoking and physical activity.
AIM 3. To estimate the scalability of the integrated cardiovascular risk reduction strategy in families of individuals with a positive history CHD for state- or nation-wide implementation. Scalability will be informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.
STUDY DESIGN:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Potential participants must be either parents, children or brothers and sisters of the affected person (individual with documented history of CHD).
- •More than 18 years of age.
Exclusion Criteria
- •Bedridden and terminally ill patients. Those who are not willing to provide written informed consent will be also excluded.
Arms & Interventions
Usual care
Screening for CVD risk factors plus one time education regarding management of risk factors will be provided to all family members.
Life style Intervention and care coordination
Integrated cardiovascular disease risk management.
Intervention: Integrated cardiovascular disease risk management. (Behavioral)
Outcomes
Primary Outcomes
Composite outcome of multiple cardiovascular risk factors
Time Frame: 2 year
Proportions achieving blood pressure\<140/90 mmHg, fasting blood glucose (FPG)\<110 mg/dl, low-density lipoprotein (LDL)\<100 mg/dl, and abstinence from smoking/tobacco use.
Secondary Outcomes
- Blood pressure(2 year)
- Blood lipids(2 Year)
- Blood Glucose(2 year)
- Behavioural factors(2 Year)
- Acute Coronary Syndrome(2 year)