Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000557
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
1999-10-27
Brief Title:
Enhancing Recovery in Coronary Heart Disease ENRICHD Patients
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
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:
None
Brief Summary:
To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk
Detailed Description:
BACKGROUND
As medical treatments for coronary heart disease have become more sophisticated they have also become more costly Evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients quality of life including return to work and to normal levels of functioning has been mixed At the same time recent data suggest that psychosocial factors such as social isolation and depression are important predictors of morbidity and mortality in coronary heart disease patients These studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients To the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients the human and financial costs associated with coronary heart disease can be reduced The initiative originated in the Working Group on Psychosocial Interventions which met in June 1992
The initiative was given concept clearance by the October 1993 National Heart Lung and Blood Advisory Council The Request for Proposals was released in September 1994
DESIGN NARRATIVE
The study design compared a psychosocial intervention group in which patients were provided with social and psychological treatment designed to decrease social isolation and depression with a standard medical care group The combined endpoint was death and reinfarction measured for up to 45 years following hospital discharge Secondary endpoints included assessment of health quality of life HQL
The protocol was approved in May 1996 Recruitment began in October 1996 and ended on October 31 1999 with 2481 patients enrolled
As medical treatments for coronary heart disease have become more sophisticated they have also become more costly Evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients quality of life including return to work and to normal levels of functioning has been mixed At the same time recent data suggest that psychosocial factors such as social isolation and depression are important predictors of morbidity and mortality in coronary heart disease patients These studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients To the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients the human and financial costs associated with coronary heart disease can be reduced The initiative originated in the Working Group on Psychosocial Interventions which met in June 1992
The initiative was given concept clearance by the October 1993 National Heart Lung and Blood Advisory Council The Request for Proposals was released in September 1994
DESIGN NARRATIVE
The study design compared a psychosocial intervention group in which patients were provided with social and psychological treatment designed to decrease social isolation and depression with a standard medical care group The combined endpoint was death and reinfarction measured for up to 45 years following hospital discharge Secondary endpoints included assessment of health quality of life HQL
The protocol was approved in May 1996 Recruitment began in October 1996 and ended on October 31 1999 with 2481 patients enrolled
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: