Self-Scored Cardiovascular Disease Risk Appraisal

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005529
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: November 2001

May 25, 2000
June 23, 2005
September 1995
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Complete list of historical versions of study NCT00005529 on ClinicalTrials.gov Archive Site
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Self-Scored Cardiovascular Disease Risk Appraisal
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To develop and test a self-scored cardiovascular disease health risk appraisal.

BACKGROUND:

Health risk appraisals (HRA) are being used increasingly by health centers and worksites to inform people of their personal mortality and morbidity risks. However, recent research suggests that many HRAs have limited reliability and validity with respect to coronary heart disease, the leading cause of death in this country. Self-scored HRAs appear to be considerably less accurate in predicting CHD risk than computerized instruments, chiefly because people do not always know the physiologic values required by these instruments and because they frequently make errors computing their scores.

DESIGN NARRATIVE:

During Phase I, a new appraisal named CardioRisk was developed. The Phase I prototype version contained eight major self-reported risk factors. CardioRisk predicted the risk of developing cardiovascular disease (CVD) in a 12-year period using an equation based on recent accelerated failure time models from the Framingham Heart Study. The purpose of Phase II was to thoroughly test and refine the prototype instrument. The Phase II analyses were designed to assess the psychometric properties of CardioRisk, to evaluate its utility as judged by patients, and to determine whether the instrument changed perceptions of personal CVD risk. These results were compared to data for other appraisals to determine whether CardioRisk outperformed comparable products.

In the proposed commercial application, CardioRisk would be distributed by health promotion organizations to increase awareness of the risk factors for cardiovascular disease. Estimates from the American Heart Association put the demand for these products at 180,000 HRAs per year. The potential market for this product includes worksites, community health centers, managed health care organizations, public health departments, and clinics.

Observational
Observational Model: Natural History
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  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Heart Disease Risk Reduction
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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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August 2000
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005529
5062
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National Heart, Lung, and Blood Institute (NHLBI)
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National Heart, Lung, and Blood Institute (NHLBI)
November 2001

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