Clinical Trials Directory

Trials / Completed

CompletedNCT01207700

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
806 (actual)
Sponsor
St. John's Research Institute · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCHW based intervention post ACSCHW is trained and supervised to provide interventions that could improved adherence to post ACS care

Timeline

Start date
2011-08-01
Primary completion
2013-07-01
Completion
2013-08-01
First posted
2010-09-23
Last updated
2014-12-02

Locations

13 sites across 1 country: India

Source: ClinicalTrials.gov record NCT01207700. Inclusion in this directory is not an endorsement.