Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005529
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Self-Scored Cardiovascular Disease Risk Appraisal
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 180000 HRAs per year The potential market for this product includes worksites community health centers managed health care organizations public health departments and clinics
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 180000 HRAs per year The potential market for this product includes worksites community health centers managed health care organizations public health departments and clinics
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44HL053166 | NIH | None | httpsreporternihgovquickSearchR44HL053166 |