Developing and testing a multicomponent care model for heart disease in India
Not Applicable
Completed
- Conditions
- Health Condition 1: I00-I99- Diseases of the circulatory system
- Registration Number
- CTRI/2022/04/041847
- Lead Sponsor
- Public Health Foundation of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 410
Inclusion Criteria
1.Age: =18 years, both sex
2.Having physician diagnosis of or on treatment for cardiovascular disease including ischemic heart disease, ischemic stroke, or heart failure regardless of ejection fraction
3.Living within same city/town
4.Consent to participate.
Exclusion Criteria
1.Pregnant women
2.Patients having diseases associated with frequent hospitalization (advanced cancer, end stage renal disease); bedridden or debilitating conditions and life expectancy <12 months that might limit completion of study follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Acceptibilty <br/ ><br>2. Adoption <br/ ><br>3. Appropriateness <br/ ><br>4. Cost <br/ ><br>5. Feasibilty <br/ ><br>6. FidelityTimepoint: maximum: 24 months, average: 18 months
- Secondary Outcome Measures
Name Time Method Other Pre-specified Outcome Measure: <br/ ><br>Between group differences in: <br/ ><br>1. Mean changes in blood pressure at trial end <br/ ><br>2. Mean changes in LDL cholesterol at <br/ ><br>trial end <br/ ><br>3. Mean change in health-related quality of life <br/ ><br>4. Incremental cost of care <br/ ><br>5. Adherence to recommended lifestyle habits: smoking cessation, diet, physical activity, and mental healthTimepoint: maximum: 24 months, average: 18 months;Prescription rate of guideline directed medical therapy (GDMT) by providers <br/ ><br>Patients adherence rate to GDMTTimepoint: maximum: 24 months, average: 18 months