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

St. John's Research Institute

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Behavioral: CHW based intervention post ACS

Study type: Interventional

Funder types: Other

Identifiers

NCT01207700

NO1-HV-98215/SJRI - DCT/SPREAD

Details and patient eligibility

About

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)

Full 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.

Enrollment: 806 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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806 participants in 2 patient groups

CHW based intervention post ACS

Experimental group

Description:

CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care

Treatment:

Behavioral: CHW based intervention post ACS

Standard Care

No Intervention group

Description:

Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital