Evaluating Tools for Health Promotion and Disease Prevention
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| ClinicalTrials.gov Identifier: NCT00164658 |
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Recruitment Status :
Completed
First Posted : September 14, 2005
Last Update Posted : January 7, 2010
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| 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 |
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 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 |
- 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
- Primary care physicians' provision of preventive services in response to family medical history.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| 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 | |
| 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 |
| 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 |
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family history familial risk behavior change |
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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |