Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01207700
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2010-09-22
Brief Title:
Secondary Prevention of coRonary Events After Discharge From Hospital SPREAD
Sponsor:
St Johns Research Institute
Organization:
St Johns Research Institute
Study Overview
Official Title:
A Randomized Open Trial Comparing Post Discharge Interventions to Standard Care
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPREAD
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 Indiadifferent partsboth secondary and tertiary care A total of 800 patients will be recruited with equal allocation to SPREAD interventions and control groups usual care
This trial will be conducted in 10 hospitals in Indiadifferent partsboth 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None