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OpenTrials
Completed

NCT Number: NCT01207700

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

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)

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Key information

Conditions

Acute Coronary Syndrome Behavior Cardiovascular Diseases Health Behavior Heart Diseases Myocardial Ischemia Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishna Institute of Medical Science Ltd, Secunderabad, Aandhra Pradesh, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHW based intervention post ACS

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

St. John's Research Institute

Other

Collaborators

  • National Heart and Lung Institute

Registry information

Official study title

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

Acronym: SPREAD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2010
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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