Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164658
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2005-09-12
Brief Title:
Evaluating Tools for Health Promotion and Disease Prevention
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Evaluating Tools for Health Promotion and Disease Prevention
Status:
COMPLETED
Status Verified Date:
2010-01
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:
The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the US
Detailed Description:
The purpose of this study is to evaluate the clinical utility of a new family history tool Family Healthware by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized not personalized prevention messages An additional hypothesis tested when participants see their primary care physician during the study is that providing a copy of the graphical family history risk and prevention messages to the patients physician will increase delivery of recommended preventive services screening referral and health habit advice
The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers The practices will be randomized into two groups Patients in practices randomized to Group 1 will complete a pre-test and the family history tool and will receive personalized prevention messages based on their level of familial risk and current risk behaviors After six months Group 1 patients will complete a post-test Patients in Group 2 will complete the pre-test and receive standard prevention messages appropriate for sex about maintaining good health and preventing disease After 6 months Group 2 patients will complete the post-test and the family history tool The pre- and post-test will include assessment of risk factors use of medical services especially preventive services interest in modifying health behaviors risk perceptions etc The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata average moderate high
The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers The practices will be randomized into two groups Patients in practices randomized to Group 1 will complete a pre-test and the family history tool and will receive personalized prevention messages based on their level of familial risk and current risk behaviors After six months Group 1 patients will complete a post-test Patients in Group 2 will complete the pre-test and receive standard prevention messages appropriate for sex about maintaining good health and preventing disease After 6 months Group 2 patients will complete the post-test and the family history tool The pre- and post-test will include assessment of risk factors use of medical services especially preventive services interest in modifying health behaviors risk perceptions etc The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata average moderate high
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U36CCU319276-MM-0630 | None | None | None |
| U50CCU300860-TS-1216 | None | None | None |
| U36CCU319276-MM-0789 | None | None | None |