Validation and Field Test for Risk Appraisal Instruments

This study has been completed.

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00005163

First received: May 25, 2000

Last updated: June 23, 2005

Last verified: May 2000

History of Changes

Tracking Information
First Received Date ^ICMJE	May 25, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 1983
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 NCT00005163 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

Descriptive Information
Brief Title ^ICMJE	Validation and Field Test for Risk Appraisal Instruments
Official Title ^ICMJE	Not Provided
Brief Summary	To field test the validity, reliability, cost, and cost-benefit of Health Risk Appraisal (HRA) instruments.
Detailed Description	BACKGROUND: Health Risk Appraisals instruments have provided the field of health promotion with an imaginative motivational and instructional tool to foster personal behavioral change. A HRA typically asked questions about smoking, blood pressure, exercise, medical history, diet and other life style variables. These risk indicators were then compared to epidemiological and mortality data to yield an estimate of an individual or group's risk for disease. They were widely regarded as the most promising new addition to the health promotion armamentarium. The National Health Information Clearinghouse divided them into the following three categories: Computer-Scored HRAs, which were mailed to a central computer facility for batch processing and were usually the more complex and detailed appraisals; Microcomputer-Based HRAs, which c;ould be processed by a microcomputer at home, in schools or at the worksite; and Self-Scored HRAs, which were usually brief, did not involve a computer, and were scored by the user. Although HRAs were a burgeoning industry in health education, no properly designed and conducted scientific evaluation of them on a sufficiently large and representative sample of the general population had been undertaken in the United States or elsewhere. DESIGN NARRATIVE: In the first stage, fourteen HRAs were evaluated by determining the validity of the scoring system for estimating cardiovascular risk as employed in the Framingham Heart Study data base, the accuracy of the reported risk factor scores as measured by physiological values, and the understandability and social acceptability of the instrument format. The second stage of the project was a field test to determine reliability and cost-effectiveness. Ten groups of respondents were formed by randomly assigning eligible adults to one of the five HRA groups and then to reliability and validity status.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Natural History
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Cardiovascular Diseases Heart Diseases Coronary Heart Disease Risk Reduction
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Washburn RA, Goldfield SR, Smith KW, McKinlay JB. The validity of self-reported exercise-induced sweating as a measure of physical activity. Am J Epidemiol. 1990 Jul;132(1):107-13. Avis NE, McKinlay JB, Smith KW. Is cardiovascular risk factor knowledge sufficient to influence behavior? Am J Prev Med. 1990 May-Jun;6(3):137-44. Smith KW, McKinlay SM, Thorington BD. The validity of health risk appraisal instruments for assessing coronary heart disease risk. Am J Public Health. 1987 Apr;77(4):419-24. Smith KW, McKinlay SM, McKinlay JB. The reliability of health risk appraisals: a field trial of four instruments. Am J Public Health. 1989 Dec;79(12):1603-7. Avis NE, Smith KW, McKinlay JB. Accuracy of perceptions of heart attack risk: what influences perceptions and can they be changed? Am J Public Health. 1989 Dec;79(12):1608-12.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	May 1989
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	No eligibility criteria
Gender	Male
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00005163
Other Study ID Numbers ^ICMJE	1035
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

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