Evaluating Tools for Health Promotion and Disease Prevention

NCT ID: NCT00164658

Last Updated: 2010-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-10-31

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).

Conditions

Coronary Heart Disease; Stroke; Diabetes; Breast Cancer; Ovarian Cancer; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Familial risk assessment and personalized prevention messages

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

American Academy of Family Physicians National Research Network

NETWORK

Sponsor Role: collaborator

Evanston Northwestern Healthcare Research Institute

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Louise S Acheson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer Center

Wendy S Rubinstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Evanston Northwestern Healthcare Research Institute

Suzanne M O'Neill, MA, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Evanston Northwestern Healthcare Research Institute

Mack T Ruffin IV, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices

Evanston, Illinois, United States

American Academy of Family Physicians National Research Network (AAFP-NRN).

Leawood, Kansas, United States

Great Lakes Research into Practice Network (GRIN)

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25901453 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22992357 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22257420 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21900440 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19460658 (View on PubMed)

Other Identifiers

U36/CCU319276-MM-0630

Identifier Type: -

Identifier Source: secondary_id

U50/CCU300860-TS-1216

Identifier Type: -

Identifier Source: secondary_id

U36/CCU319276-MM-0789

Identifier Type: -

Identifier Source: secondary_id

CDC-OGDP-4444

Identifier Type: -

Identifier Source: org_study_id