Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

NCT ID: NCT00000557

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-09-30
• Study Completion Date: 2005-09-30

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 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.

Conditions

Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Study Design

• Primary Study Purpose: PREVENTION

Interventions

social support

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Diane Catellier

Role:

University of North Carolina

References

Enhancing recovery in coronary heart disease patients (ENRICHD): study design and methods. The ENRICHD investigators. Am Heart J. 2000 Jan;139(1 Pt 1):1-9. doi: 10.1016/s0002-8703(00)90301-6.

Reference Type: BACKGROUND

PMID: 10618555 (View on PubMed)

Blumenthal JA, O'Connor C, Hinderliter A, Fath K, Hegde SB, Miller G, Puma J, Sessions W, Sheps D, Zakhary B, Williams RB. Psychosocial factors and coronary disease. A national multicenter clinical trial (ENRICHD) with a North Carolina focus. N C Med J. 1997 Nov-Dec;58(6):440-4.

Reference Type: BACKGROUND

PMID: 9392958 (View on PubMed)

ENRICHD Investigators. Enhancing recovery in coronary heart disease (ENRICHD): baseline characteristics. Am J Cardiol. 2001 Aug 1;88(3):316-22. doi: 10.1016/s0002-9149(01)01652-6. No abstract available.

Reference Type: BACKGROUND

PMID: 11472719 (View on PubMed)

Mendes de Leon CF, Dilillo V, Czajkowski S, Norten J, Schaefer J, Catellier D, Blumenthal JA; Enhancing Recovery in Coronary Heart Disease (ENRICHD) Pilot Study. Psychosocial characteristics after acute myocardial infarction: the ENRICHD pilot study. Enhancing Recovery in Coronary Heart Disease. J Cardiopulm Rehabil. 2001 Nov-Dec;21(6):353-62. doi: 10.1097/00008483-200111000-00003.

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PMID: 11767809 (View on PubMed)

ENRICHD Investigators. Enhancing Recovery in Coronary Heart Disease (ENRICHD) study intervention: rationale and design. Psychosom Med. 2001 Sep-Oct;63(5):747-55.

Reference Type: BACKGROUND

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Freedland KE, Skala JA, Carney RM, Raczynski JM, Taylor CB, Mendes de Leon CF, Ironson G, Youngblood ME, Krishnan KR, Veith RC. The Depression Interview and Structured Hamilton (DISH): rationale, development, characteristics, and clinical validity. Psychosom Med. 2002 Nov-Dec;64(6):897-905. doi: 10.1097/01.psy.0000028826.64279.29.

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Watkins LL, Schneiderman N, Blumenthal JA, Sheps DS, Catellier D, Taylor CB, Freedland KE; ENRICHD Investigators. Cognitive and somatic symptoms of depression are associated with medical comorbidity in patients after acute myocardial infarction. Am Heart J. 2003 Jul;146(1):48-54. doi: 10.1016/S0002-8703(03)00083-8.

Reference Type: BACKGROUND

PMID: 12851607 (View on PubMed)

Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. doi: 10.1001/jama.289.23.3106.

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Carney RM, Blumenthal JA, Catellier D, Freedland KE, Berkman LF, Watkins LL, Czajkowski SM, Hayano J, Jaffe AS. Depression as a risk factor for mortality after acute myocardial infarction. Am J Cardiol. 2003 Dec 1;92(11):1277-81. doi: 10.1016/j.amjcard.2003.08.007.

Reference Type: BACKGROUND

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Barefoot JC, Burg MM, Carney RM, Cornell CE, Czajkowski SM, Freedland KE, Hosking JD, Khatri P, Pitula CR, Sheps D. Aspects of social support associated with depression at hospitalization and follow-up assessment among cardiac patients. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):404-12. doi: 10.1097/00008483-200311000-00002.

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Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):398-403. doi: 10.1097/00008483-200311000-00001. No abstract available.

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Froelicher ES, Miller NH, Buzaitis A, Pfenninger P, Misuraco A, Jordan S, Ginter S, Robinson E, Sherwood J, Wadley V. The Enhancing Recovery in Coronary Heart Disease Trial (ENRICHD): strategies and techniques for enhancing retention of patients with acute myocardial infarction and depression or social isolation. J Cardiopulm Rehabil. 2003 Jul-Aug;23(4):269-80. doi: 10.1097/00008483-200307000-00004.

Reference Type: BACKGROUND

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Blumenthal JA, Babyak MA, Carney RM, Huber M, Saab PG, Burg MM, Sheps D, Powell L, Taylor CB, Kaufmann PG. Exercise, depression, and mortality after myocardial infarction in the ENRICHD trial. Med Sci Sports Exerc. 2004 May;36(5):746-55. doi: 10.1249/01.mss.0000125997.63493.13.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Carney RM, Blumenthal JA, Freedland KE, Youngblood M, Veith RC, Burg MM, Cornell C, Saab PG, Kaufmann PG, Czajkowski SM, Jaffe AS; ENRICHD Investigators. Depression and late mortality after myocardial infarction in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study. Psychosom Med. 2004 Jul-Aug;66(4):466-74. doi: 10.1097/01.psy.0000133362.75075.a6.

Reference Type: BACKGROUND

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Vaglio J Jr, Conard M, Poston WS, O'Keefe J, Haddock CK, House J, Spertus JA. Testing the performance of the ENRICHD Social Support Instrument in cardiac patients. Health Qual Life Outcomes. 2004 May 13;2:24. doi: 10.1186/1477-7525-2-24.

Reference Type: BACKGROUND

PMID: 15142277 (View on PubMed)

Powell LH, Catellier D, Freedland KE, Burg MM, Woods SL, Bittner V, Calvin JE, Blumenthal JA; ENRICHD Investigators. Depression and heart failure in patients with a new myocardial infarction. Am Heart J. 2005 May;149(5):851-5. doi: 10.1016/j.ahj.2004.08.007.

Reference Type: BACKGROUND

PMID: 15894967 (View on PubMed)

Carney RM, Blumenthal JA, Freedland KE, Stein PK, Howells WB, Berkman LF, Watkins LL, Czajkowski SM, Hayano J, Domitrovich PP, Jaffe AS. Low heart rate variability and the effect of depression on post-myocardial infarction mortality. Arch Intern Med. 2005 Jul 11;165(13):1486-91. doi: 10.1001/archinte.165.13.1486.

Reference Type: BACKGROUND

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Taylor CB, Youngblood ME, Catellier D, Veith RC, Carney RM, Burg MM, Kaufmann PG, Shuster J, Mellman T, Blumenthal JA, Krishnan R, Jaffe AS; ENRICHD Investigators. Effects of antidepressant medication on morbidity and mortality in depressed patients after myocardial infarction. Arch Gen Psychiatry. 2005 Jul;62(7):792-8. doi: 10.1001/archpsyc.62.7.792.

Reference Type: BACKGROUND

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Burg MM, Barefoot J, Berkman L, Catellier DJ, Czajkowski S, Saab P, Huber M, DeLillo V, Mitchell P, Skala J, Taylor CB; ENRICHD Investigators. Low perceived social support and post-myocardial infarction prognosis in the enhancing recovery in coronary heart disease clinical trial: the effects of treatment. Psychosom Med. 2005 Nov-Dec;67(6):879-88. doi: 10.1097/01.psy.0000188480.61949.8c.

Reference Type: BACKGROUND

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Study Documents

Document Type: Individual Participant Data Set

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.

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Document Type: Study Protocol

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Document Type: Manual of Procedures

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Other Identifiers

101

Identifier Type: -

Identifier Source: org_study_id