search
Back to results

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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
CHW based intervention post ACS
Sponsored by
St. John's Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring post discharge intervention, adherence, compliance, community health worker

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krishna Institute of Medical Science Ltd
  • Mahavir Hospital & Research Centre
  • Nanjappa Hospital
  • Caritas Hospital
  • Bhopal Memorial Hospital
  • Avanti Institute of Cardiology
  • Poona Hospital
  • Mahatma Gandhi Institute of Medical Science Sevagram
  • Fortis Escorts Hospital
  • Rajamuthiah Medical College & Hospital
  • PSG Hospital
  • Sahara Hospital
  • Sir Ganga Ram Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CHW based intervention post ACS

Standard Care

Arm Description

CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care

Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
September 22, 2010
Last Updated
November 27, 2014
Sponsor
St. John's Research Institute
Collaborators
National Heart and Lung Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01207700
Brief Title
Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
Acronym
SPREAD
Official Title
A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. John's Research Institute
Collaborators
National Heart and Lung Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: Feasibility Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
post discharge intervention, adherence, compliance, community health worker

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHW based intervention post ACS
Arm Type
Experimental
Arm Description
CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital
Intervention Type
Behavioral
Intervention Name(s)
CHW based intervention post ACS
Intervention Description
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
Primary Outcome Measure Information:
Title
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
Description
Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker
Time Frame
12 months
Title
To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
Description
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
Time Frame
12 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rajeev Gupta, MD, PHD
Organizational Affiliation
Fortis Escorts Hospital, Jaipur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishna Institute of Medical Science Ltd
City
Secunderabad
State/Province
Aandhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Mahavir Hospital & Research Centre
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500004
Country
India
Facility Name
Nanjappa Hospital
City
Shimoga
State/Province
Karnataka
ZIP/Postal Code
577201
Country
India
Facility Name
Caritas Hospital
City
Kottayam
State/Province
Kerala
Country
India
Facility Name
Bhopal Memorial Hospital
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462038
Country
India
Facility Name
Avanti Institute of Cardiology
City
Nagpur
State/Province
Maharastra
ZIP/Postal Code
440012
Country
India
Facility Name
Poona Hospital
City
Pune
State/Province
Maharastra
Country
India
Facility Name
Mahatma Gandhi Institute of Medical Science Sevagram
City
Wardha
State/Province
Maharastra
ZIP/Postal Code
442001
Country
India
Facility Name
Fortis Escorts Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Rajamuthiah Medical College & Hospital
City
Annamalai
State/Province
Tamil Nadu
ZIP/Postal Code
608 002
Country
India
Facility Name
PSG Hospital
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 004
Country
India
Facility Name
Sahara Hospital
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226010
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26857999
Citation
Xavier D, Gupta R, Kamath D, Sigamani A, Devereaux PJ, George N, Joshi R, Pogue J, Pais P, Yusuf S. Community health worker-based intervention for adherence to drugs and lifestyle change after acute coronary syndrome: a multicentre, open, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):244-253. doi: 10.1016/S2213-8587(15)00480-5. Epub 2016 Feb 6.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs