A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- St. John's Research Institute
- Enrollment
- 806
- Locations
- 13
- Primary Endpoint
- To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients.
This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD interventions and control groups (usual care)
Detailed Description
Inclusion criteria: Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI). Exclusion criteria: Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up. OUTCOME MEASURES: 1. Feasibility 2. Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.
Investigators
Dr Alben Sigamani
Associate Professor
St. John's Research Institute
Eligibility Criteria
Inclusion Criteria
- •Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Exclusion Criteria
- •Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up
Outcomes
Primary Outcomes
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
Time Frame: 12 months
Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker
To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
Time Frame: 12 MONTHS
A pilot study to look at feasibiility of using a trained community health worker to deliver health messages to patients who have had a coronary event