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

Acute Coronary Syndrome Clinical Trial

— SPREAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207700
• Other study ID #: NO1-HV-98215/SJRI - DCT/SPREAD
• Status: Completed
• Phase: N/A
• First received: September 22, 2010
• Last updated: November 27, 2014
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2014
• Source: St. John's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical ResearchIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Behavioral:
• CHW based intervention post ACS
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care

Locations

Country	Name	City	State
India	Rajamuthiah Medical College & Hospital	Annamalai	Tamil Nadu
India	Bhopal Memorial Hospital	Bhopal	Madhya Pradesh
India	PSG Hospital	Coimbatore	Tamil Nadu
India	Mahavir Hospital & Research Centre	Hyderabad	Andhra Pradesh
India	Fortis Escorts Hospital	Jaipur	Rajasthan
India	Caritas Hospital	Kottayam	Kerala
India	Sahara Hospital	Lucknow	Uttar Pradesh
India	Avanti Institute of Cardiology	Nagpur	Maharastra
India	Sir Ganga Ram Hospital	New Delhi
India	Poona Hospital	Pune	Maharastra
India	Krishna Institute of Medical Science Ltd	Secunderabad	Aandhra Pradesh
India	Nanjappa Hospital	Shimoga	Karnataka
India	Mahatma Gandhi Institute of Medical Science Sevagram	Wardha	Maharastra

Sponsors (2)

Lead Sponsor	Collaborator
St. John's Research Institute	National Heart and Lung Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events	Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker	12 months	No
Primary	To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice	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	No