Clinical trial NCT00164658: Evaluating Tools for Health Promotion and Disease Prevention
Official title: Evaluating Tools for Health Promotion and Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Heart Disease
Stroke
Diabetes
Breast Cancer
Ovarian Cancer
Colorectal Cancer
Keywords: family history
familial risk
behavior change
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Case Western Reserve University
name: American Academy of Family Physicians National Research Network
name: Evanston Northwestern Healthcare Research Institute
name: University of Michigan
First posted: 2005-09-14
Enrollment: 8400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 U.S.

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 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).

Eligibility 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Primary care physicians' provision of preventive services in response to family medical history.
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices
state: Illinois
city: Leawood
country: United States
facility: American Academy of Family Physicians National Research Network (AAFP-NRN).
state: Kansas
city: Ann Arbor
country: United States
facility: Great Lakes Research into Practice Network (GRIN)
state: Michigan
Study officials:
affiliation: Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer Center
name: Louise S Acheson, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Evanston Northwestern Healthcare Research Institute
name: Wendy S Rubinstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evanston Northwestern Healthcare Research Institute
name: Suzanne M O'Neill, MA, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Mack T Ruffin IV, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang C, Sen A, Plegue M, Ruffin MT 4th, O'Neill SM, Rubinstein WS, Acheson LS; Family Healthware Impact Trial (FHITr) Group; Family Healthware Impact Trial FHITr Group. Impact of family history assessment on communication with family members and health care providers: A report from the Family Healthware Impact Trial (FHITr). Prev Med. 2015 Aug;77:28-34. doi: 10.1016/j.ypmed.2015.04.007. Epub 2015 Apr 19.
citation: Wang C, Sen A, Ruffin MT 4th, Nease DE Jr, Gramling R, Acheson LS, O'Neill SM, Rubinstein WS; Family Healthware Impact Trial (FHITr) Group. Family history assessment: impact on disease risk perceptions. Am J Prev Med. 2012 Oct;43(4):392-8. doi: 10.1016/j.amepre.2012.06.013.
citation: Dorman JS, Valdez R, Liu T, Wang C, Rubinstein WS, O'Neill SM, Acheson LS, Ruffin MT 4th, Khoury MJ. Health beliefs among individuals at increased familial risk for type 2 diabetes: implications for prevention. Diabetes Res Clin Pract. 2012 May;96(2):156-62. doi: 10.1016/j.diabres.2011.12.017. Epub 2012 Jan 17.
citation: Ruffin MT 4th, Nease DE Jr. Using patient monetary incentives and electronically derived patient lists to recruit patients to a clinical trial. J Am Board Fam Med. 2011 Sep-Oct;24(5):569-75. doi: 10.3122/jabfm.2011.05.100169.
citation: O'Neill SM, Rubinstein WS, Wang C, Yoon PW, Acheson LS, Rothrock N, Starzyk EJ, Beaumont JL, Galliher JM, Ruffin MT 4th; Family Healthware Impact Trial group. Familial risk for common diseases in primary care: the Family Healthware Impact Trial. Am J Prev Med. 2009 Jun;36(6):506-14. doi: 10.1016/j.amepre.2009.03.002.