Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients
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|ClinicalTrials.gov Identifier: NCT00000557|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 14, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Coronary Disease Depression Heart Diseases Myocardial Infarction Myocardial Ischemia||Behavioral: social support||Phase 3|
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.
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 4.5 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 2,481 patients enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||September 1995|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||September 2005|
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000557
|OverallOfficial:||Diane Catellier||University of North Carolina|
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
|Other Study ID Numbers:||
|First Posted:||October 28, 1999 Key Record Dates|
|Last Update Posted:||April 14, 2016|
|Last Verified:||January 2008|