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Evaluating Tools for Health Promotion and Disease Prevention


Phase 1
35 Years
65 Years
Not Enrolling
Both
Coronary Heart Disease, Stroke, Diabetes, Breast Cancer, Ovarian Cancer, Colorectal Cancer

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Trial Information

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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Outcome 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

Principal Investigator

Louise S Acheson, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CDC-OGDP-4444

NCT ID:

NCT00164658

Start Date:

September 2005

Completion Date:

October 2007

Related Keywords:

  • Coronary Heart Disease
  • Stroke
  • Diabetes
  • Breast Cancer
  • Ovarian Cancer
  • Colorectal Cancer
  • family history
  • familial risk
  • behavior change
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases
  • Ovarian Neoplasms
  • Stroke

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