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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Behavioral: CHW based intervention post ACS

• Registration Number: NCT01207700
• Lead Sponsor: St. John's Research Institute

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.

Study Timeline

• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Study Start: 2011-08
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 806

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events	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	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

Trial Locations

Locations (13)

Krishna Institute of Medical Science Ltd; 🇮🇳 Secunderabad, Aandhra Pradesh, India

Bhopal Memorial Hospital; 🇮🇳 Bhopal, Madhya Pradesh, India

Nanjappa Hospital; 🇮🇳 Shimoga, Karnataka, India

Mahavir Hospital & Research Centre; 🇮🇳 Hyderabad, Andhra Pradesh, India

Poona Hospital; 🇮🇳 Pune, Maharastra, India

Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India

Mahatma Gandhi Institute of Medical Science Sevagram; 🇮🇳 Wardha, Maharastra, India

Avanti Institute of Cardiology; 🇮🇳 Nagpur, Maharastra, India

PSG Hospital; 🇮🇳 Coimbatore, Tamil Nadu, India

Caritas Hospital; 🇮🇳 Kottayam, Kerala, India

Sahara Hospital; 🇮🇳 Lucknow, Uttar Pradesh, India

Rajamuthiah Medical College & Hospital; 🇮🇳 Annamalai, Tamil Nadu, India

Fortis Escorts Hospital; 🇮🇳 Jaipur, Rajasthan, India