Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000557
First received: October 27, 1999
Last updated: January 15, 2008
Last verified: January 2008

October 27, 1999
January 15, 2008
September 1995
September 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000557 on ClinicalTrials.gov Archive Site
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Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients
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To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk.

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 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.

Interventional
Phase 3
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Coronary Disease
  • Depression
  • Heart Diseases
  • Myocardial Infarction
  • Myocardial Ischemia
Behavioral: social support
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2005
September 2005   (final data collection date for primary outcome measure)

Men and women coronary heart disease/myocardial infarction patients, hospitalized for enzyme-documented MI and who are depressed and/or have low social support. Patients must be enrolled with 28 days of the index MI.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000557
101
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Diane Catellier University of North Carolina
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP