Evaluating Tools for Health Promotion and Disease Prevention
The purpose of this study is to evaluate the clinical utility of a new family history tool,
Family Healthwareâ„¢ 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 patient's 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).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation
Louise S Acheson, MD, MS
Principal Investigator
Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer Center
United States: Federal Government
CDC-OGDP-4444
NCT00164658
September 2005
October 2007
Name | Location |
---|---|
Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices | Evanston, Illinois 60201 |
American Academy of Family Physicians National Research Network (AAFP-NRN). | Leawood, Kansas 66211 |
Great Lakes Research into Practice Network (GRIN) | Ann Arbor, Michigan 48109 |