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

N/ACompletedNCT01207700

St. John's Research Institute806 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

806

Conditions

Acute Coronary Syndrome

Interventions

CHW based intervention post ACSBEHAVIORAL

CHW is trained and supervised to provide interventions that could improved adherence to post ACS care

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (13)

Krishna Institute of Medical Science Ltd

Secunderabad, Aandhra Pradesh, India

Mahavir Hospital & Research Centre

Hyderabad, Andhra Pradesh, India

Nanjappa Hospital

Shimoga, Karnataka, India

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 12 MONTHS

Data from ClinicalTrials.gov

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