Overview

This trial is active, not recruiting.

Condition acute coronary syndrome
Treatments community health worker, vita tool, no intervention
Sponsor St. John's Research Institute
Collaborator National Heart and Lung Institute
Start date August 2011
End date July 2013
Trial size 800 participants
Trial identifier NCT01207700, NO1-HV-98215/SJRI - DCT/SPREAD

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
Home visits by the community health worker, tools for reminders to take medications, material for patients awareness of the importance of secondary prevention
community health worker, vita tool A) Patient Reinforcement Form
The community Health Worker will use the V
(Other)
Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital
no intervention clinical follow up
regular hospital based practice

Primary Outcomes

Measure
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
time frame: 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

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Official title A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
Principal investigator Dr. Rajeev Gupta, MD, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by St. John's Research Institute.