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

November 27, 2014 updated by: Dr Alben Sigamani, St. John's Research Institute

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

806

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
    • Aandhra Pradesh
      • Secunderabad, Aandhra Pradesh, India, 500003
        • Krishna Institute of Medical Science Ltd
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500004
        • Mahavir Hospital & Research Centre
    • Karnataka
      • Shimoga, Karnataka, India, 577201
        • Nanjappa Hospital
    • Kerala
      • Kottayam, Kerala, India
        • Caritas Hospital
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462038
        • Bhopal Memorial Hospital
    • Maharastra
      • Nagpur, Maharastra, India, 440012
        • Avanti Institute of Cardiology
      • Pune, Maharastra, India
        • Poona Hospital
      • Wardha, Maharastra, India, 442001
        • Mahatma Gandhi Institute of Medical Science Sevagram
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Fortis Escorts Hospital
    • Tamil Nadu
      • Annamalai, Tamil Nadu, India, 608 002
        • Rajamuthiah Medical College & Hospital
      • Coimbatore, Tamil Nadu, India, 641 004
        • PSG Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226010
        • Sahara Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHW based intervention post ACS
CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care
Behavioral: CHW based intervention post ACS
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
No Intervention: Standard Care
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?

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
Time Frame: 12 months
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
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
12 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. John's Research Institute

Collaborators

National Heart and Lung Institute

Investigators

  • Principal Investigator: Dr. Rajeev Gupta, MD, PHD, Fortis Escorts Hospital, Jaipur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 27, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO1-HV-98215/SJRI - DCT/SPREAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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