Self-Scored Cardiovascular Disease Risk Appraisal - Tabular View

Tracking Information
First Received Date ^ICMJE	May 25, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 1995
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Self-Scored Cardiovascular Disease Risk Appraisal
Official Title ^ICMJE
Brief Summary	To develop and test a self-scored cardiovascular disease health risk appraisal.
Detailed Description	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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Natural History
Condition ^ICMJE	Cardiovascular Diseases Heart Diseases Coronary Heart Disease Risk Reduction
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	August 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	No eligibility criteria
Gender	Male
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00005529
Responsible Party
Study ID Numbers ^ICMJE	5062
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	November 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP