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 U.S.

Condition	Intervention	Phase
Coronary Heart Disease Stroke Diabetes Breast Cancer Ovarian Cancer Colorectal Cancer	Behavior: Familial risk assessment and personalized prevention messages	Phase I

Further Study Details: 

Primary Outcomes: 1. Change in stage of adoption of health behaviors (e.g., diet, exercise, smoking) as assessed by the Trans Theoretical Model at 6 months post intervention.; 2. Scheduled or completion of indicated disease screening at 6 months post evaluation; 3. Referral for additional screening and follow up for high risk participants at 6 month post evaluation
Secondary Outcomes: 1. Primary care physicians'''' provision of preventive services in response to information provided by the Family Healthware™; 2. Effect of the Family Healthware™ tool on communication about family medical history between patient and health care providers and patient and family members
Expected Total Enrollment:  8400

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 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).

Ages Eligible for Study:  35 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• member of participating primary care practice network
• able to provide informed consent
• able to complete data assessment tools in English

Exclusion Criteria:

• diagnosis of CHD, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer
• currently pregnant
• evidence of cognitive impairment

Please refer to this study by ClinicalTrials.gov identifier  NCT00164658

Paula W Yoon, ScD, MPH      770-488-8436    pyoon@cdc.gov

Illinois
      Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices, Evanston,  Illinois,  60201,  United States
Kansas
      American Academy of Family Physicians National Research Network (AAFP-NRN)., Leawood,  Kansas,  66211,  United States
Michigan
      Great Lakes Research into Practice Network (GRIN), Ann Arbor,  Michigan,  48109,  United States

Study chairs or principal investigators

Louise S Acheson, MD, MS,  Principal Investigator,  Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer Center   
Wendy S Rubinstein, MD, PhD,  Principal Investigator,  Evanston Northwestern Healthcare Research Institute   
Suzanne M O''''Neill, MA, MS, PhD,  Principal Investigator,  Evanston Northwestern Healthcare Research Institute   
Mack T Ruffin IV, MD, MPH,  Principal Investigator,  University of Michigan   

Study ID Numbers:  CDC-OGDP-4444; U36/CCU319276-MM-0630; U50/CCU300860-TS-1216; U36/CCU319276-MM-0789
Last Updated:  September 13, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00164658
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-20