Evaluating Tools for Health Promotion and Disease Prevention

NCT00164658 | Completed Phase 1

• 4 other identifiers: CDC-OGDP-4444U36/CCU319276-MM-0630U50/CCU300860-TS-1216U36/CCU319276-MM-0789
• Study Type: interventional
• Target: 8,400
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

family history; familial risk; behavior change

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Primary care physicians' provision of preventive services in response to family medical history.

Interventions

Familial risk assessment and personalized prevention messages BEHAVIORAL

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Case Western Reserve University: collaborator
• American Academy of Family Physicians National Research Network: collaborator
• Evanston Northwestern Healthcare Research Institute: collaborator
• University of Michigan: collaborator

Study Sites (3)

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

Evanston, Illinois, 60201, United States

Location

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

Leawood, Kansas, 66211, United States

Location

Great Lakes Research into Practice Network (GRIN)

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (5)

• 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.

  PMID: 25901453 DERIVED

• 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.

  PMID: 22992357 DERIVED

• 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.

  PMID: 22257420 DERIVED

• 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.

  PMID: 21900440 DERIVED

• 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.

  PMID: 19460658 DERIVED

MeSH Terms

Conditions

Coronary Disease; Stroke; Diabetes Mellitus; Breast Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Louise S Acheson, MD, MS

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

  PRINCIPAL INVESTIGATOR

• Wendy S Rubinstein, MD, PhD

  Evanston Northwestern Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

• Suzanne M O'Neill, MA, MS, PhD

  Evanston Northwestern Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

• Mack T Ruffin IV, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Study Completion: October 1, 2007
• Last Updated: January 7, 2010

Record last verified: 2010-01

Locations

US (3)