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Evaluating Tools for Health Promotion and Disease Prevention

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ClinicalTrials.gov Identifier: NCT00164658
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 7, 2010
Sponsor:
Collaborators:
Case Western Reserve University
American Academy of Family Physicians National Research Network
Evanston Northwestern Healthcare Research Institute
University of Michigan
Information provided by:
Centers for Disease Control and Prevention

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Stroke Diabetes Breast Cancer Ovarian Cancer Colorectal Cancer Behavioral: Familial risk assessment and personalized prevention messages Phase 1

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Evaluating Tools for Health Promotion and Disease Prevention
Study Start Date : September 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Primary care physicians' provision of preventive services in response to family medical history.

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164658


Locations
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United States, Illinois
Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices
Evanston, Illinois, United States, 60201
United States, Kansas
American Academy of Family Physicians National Research Network (AAFP-NRN).
Leawood, Kansas, United States, 66211
United States, Michigan
Great Lakes Research into Practice Network (GRIN)
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Centers for Disease Control and Prevention
Case Western Reserve University
American Academy of Family Physicians National Research Network
Evanston Northwestern Healthcare Research Institute
University of Michigan
Investigators
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Principal Investigator: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00164658    
Other Study ID Numbers: CDC-OGDP-4444
U36/CCU319276-MM-0630
U50/CCU300860-TS-1216
U36/CCU319276-MM-0789
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: January 2010
Keywords provided by Centers for Disease Control and Prevention:
family history
familial risk
behavior change
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases