Prediction of Quality of Life in Cardiovascular Disease
|First Received Date ICMJE||May 25, 2000|
|Last Updated Date||June 23, 2005|
|Start Date ICMJE||April 1992|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005420 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Prediction of Quality of Life in Cardiovascular Disease|
|Official Title ICMJE||Not Provided|
To develop an integrative predictive model of long-term quality of life in cardiovascular disease that emphasized adaptive processes and outcomes.
Modern treatments for cardiovascular disease that enhance survival have increased the need to understand and improve corresponding aspects of quality of life. The increasing interest in prevention and health promotion in contemporary cardiovascular care emphasizes reducing risk factors that have major behavioral components, such as smoking, diet, and exercise. Personal and social resources and psychological coping strategies are associated with quality of life both directly and indirectly, through such positive health behaviors. Findings from this research provided an essential foundation for continued investigation focusing on longer-term changes in health status and quality of life in a planned ten-year follow-up with the present sample.
The study developed and tested an integrative prospective structural equation model of the interrelationships among social resources, coping strategies, positive health behaviors, and quality of life in cardiovascular disease over a four-year time-period. It also contrasted predictive findings relating to cardiac illness, stroke, and hypertension with predictive findings from matched-control groups of healthy individuals and individuals with very serious (cancer) and moderately serious (arthritis) noncardiovascular disease.
The research involved secondary data analysis with a large sample of individuals surveyed through the Center for Health Care Evaluation at the Stanford University Medical School. The sample included individuals between the ages of 55 and 65 who had used medical services in two large medical centers. Extensive psychosocial and physical health data were available from mail-out inventories at three points in time over a four- year period. Of eligible respondents contacts, 92 percent agreed to participate in the initial survey, and 89 percent (1884) of them provided complete data. Participation in one-year and four-year follow-ups approached 90 percent of surviving respondents from the previous survey. At the initial testing, 411 respondents (22 percent) reported diagnosed cardiac illness (excluding stroke and hypertension), 83 respondents (5 percent) reported diagnosed strokes, and 593 respondents (31 percent) reported diagnosed hypertension.
The data base at all three measurement times included extensive information on the quality of life, positive health behaviors, personal and social resources, and coping strategies. Computerized hospital medical records were available for one-third of the sample, and were used to evaluate the reliability of subjects' self-reports of medical conditions and health status. Group comparisons were made on two dimensions: illness type and post-illness time interval. Longitudinal analyses were used to examine causal influences on positive health behaviors and quality of life, and to develop and test an integrative predictive model.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Natural History|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||March 1995|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
No eligibility criteria
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00005420|
|Other Study ID Numbers ICMJE||4338|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||May 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP