Cardiovascular DiseasesNCT00005163
Validation and Field Test for Risk Appraisal Instruments
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To field test the validity, reliability, cost, and cost-benefit of Health Risk Appraisal (HRA) instruments. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1983to May 1989
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To field test the validity, reliability, cost, and cost-benefit of Health Risk Appraisal (HRA) instruments.
Read the 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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1983
- Study completionMay 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005163
- Sponsor's protocol ID
- 1035
- Other IDs
- R01HL032141
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
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. doi: 10.1093/oxfordjournals.aje.a115622.
PubMed 2192545Avis 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.
PubMed 2397137Smith 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. doi: 10.2105/ajph.77.4.419.
PubMed 3826459Smith 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. doi: 10.2105/ajph.79.12.1603.
PubMed 2817186Avis 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. doi: 10.2105/ajph.79.12.1608.
PubMed 2817187
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Field Test for Risk Appraisal Instruments
- ClinicalTrials.gov ID
- NCT00005163
- Acronym / sponsor ID
- 1035
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1983
- Study completion
- May 1989 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 2192545Washburn 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. doi: 10.1093/oxfordjournals.aje.a115622.
- Background: PubMed 2397137Avis 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.
- Background: PubMed 3826459Smith 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. doi: 10.2105/ajph.77.4.419.
- Background: PubMed 2817186Smith 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. doi: 10.2105/ajph.79.12.1603.
- Background: PubMed 2817187Avis 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. doi: 10.2105/ajph.79.12.1608.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005163, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.