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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005334
Other study ID # 4189
Secondary ID R01HL044436
Status Completed
Phase N/A
First received May 25, 2000
Last updated March 15, 2016
Start date July 1991
Est. completion date June 1995

Study information

Verified date June 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To study the personality and environmental factors that may determine the short-term and long-term sequelae of coronary artery bypass surgery (CABS).


Description:

BACKGROUND:

Coronary artery bypass surgery, or CABS, is one of the most common surgical procedures for treating patients with coronary artery disease (CAD). A significant number of patients have accelerated atherosclerosis in the postsurgical period and require second and third operations. Moreover, relative to standard medical care, CABS does little to prolong life. The major benefit of the procedure is improving life quality. Thus, to enhance this major benefit of CABS, it is important to understand the factors, psychosocial as well as biological, that might enhance quality of life after CABS. The few available studies on the psychosocial aspects of recovery from CABS suggest that person variables evident prior to surgery are related to postsurgery quality of life. Of special interest here are gender, optimism, Type A, with its component behavior of hostility, and repressive style. The significance of these attributes derives from their theoretical and empirical relationships to the patient's illness representations and correspondent coping responses, and/or their relationship to risk for coronary heart disease (CHD). In addition to person variables, a number of environmental variables might also be expected to play a role in recovery. Variables such as socioeconomic status (SES), major life events, and quantity and quality of social support systems have all been shown to impact on health and illness. Moreover, from a slightly different perspective, the patient's illness itself can serve as an environmental variable impinging on the life of the person providing the primary support. Thus, it is also important to understand how the patient's illness impacts on the provider of the primary support.

DESIGN NARRATIVE:

A total of 305 patients between the ages of 25 and 70 scheduled for elective surgery at a major local hospital were evaluated two weeks prior to surgery on the day prior to surgery, and one week, six months, and two and a half years postsurgery. Primary support persons were evaluated three times--at intake, six months postsurgery, and two and a half years postsurgery. Medical information was obtained that permitted examination of the influences of psychosocial variables on recovery. Major personality variables under investigation were optimism, Type A, hostility, gender, repressive style, and to a lesser extent, anxiety, and neuroticism. Major environmental variables included quality and quantity of social support and availability of a primary support person. Main outcome variables for patients included satisfaction with different life domains, depression, return to work, normalization of life style, and new and recurrent morbidity. Main outcome variables for the support person included perceptions of burden, depression, and life satisfaction.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 1995
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (7)

Carver CS, Pozo C, Harris SD, Noriega V, Scheier MF, Robinson DS, Ketcham AS, Moffat FL Jr, Clark KC. How coping mediates the effect of optimism on distress: a study of women with early stage breast cancer. J Pers Soc Psychol. 1993 Aug;65(2):375-90. — View Citation

Carver CS, Scheier MF. Situational coping and coping dispositions in a stressful transaction. J Pers Soc Psychol. 1994 Jan;66(1):184-95. — View Citation

Newsom JT, Schulz R. Social support as a mediator in the relation between functional status and quality of life in older adults. Psychol Aging. 1996 Mar;11(1):34-44. — View Citation

Nieboer AP, Schulz R, Matthews KA, Scheier MF, Ormel J, Lindenberg SM. Spousal caregivers' activity restriction and depression: a model for changes over time. Soc Sci Med. 1998 Nov;47(9):1361-71. — View Citation

Scheier MF, Bridges MW. Person variables and health: personality predispositions and acute psychological states as shared determinants for disease. Psychosom Med. 1995 May-Jun;57(3):255-68. Review. — View Citation

Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. — View Citation

Scheier MF, Matthews KA, Owens JF, Schulz R, Bridges MW, Magovern GJ, Carver CS. Optimism and rehospitalization after coronary artery bypass graft surgery. Arch Intern Med. 1999 Apr 26;159(8):829-35. — View Citation

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