Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)

Study Overview
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Brief Summary
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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
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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: Feasibility Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.

Official Title
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A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Behavioral: CHW based intervention post ACS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHW based intervention post ACS<br>CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care | Behavioral: CHW based intervention post ACS<br>* CHW is trained and supervised to provide interventions that could improved adherence to post ACS care<br>|
| No Intervention: Standard Care<br>Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events | Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker | 12 months | 
| To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice | 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 | 12 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post discharge intervention, adherence, compliance, community health worker