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Evaluating Tools for Health Promotion and Disease Prevention

Primary Purpose

Coronary Heart Disease, Stroke, Diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Familial risk assessment and personalized prevention messages
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring family history, familial risk, behavior change

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices
  • American Academy of Family Physicians National Research Network (AAFP-NRN).
  • Great Lakes Research into Practice Network (GRIN)

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 12, 2005
Last Updated
January 6, 2010
Sponsor
Centers for Disease Control and Prevention
Collaborators
Case Western Reserve University, American Academy of Family Physicians National Research Network, Evanston Northwestern Healthcare Research Institute, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00164658
Brief Title
Evaluating Tools for Health Promotion and Disease Prevention
Official Title
Evaluating Tools for Health Promotion and Disease Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Case Western Reserve University, American Academy of Family Physicians National Research Network, Evanston Northwestern Healthcare Research Institute, University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Stroke, Diabetes, Breast Cancer, Ovarian Cancer, Colorectal Cancer
Keywords
family history, familial risk, behavior change

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
8400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Familial risk assessment and personalized prevention messages
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Primary care physicians' provision of preventive services in response to family medical history.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise S Acheson, MD, MS
Organizational Affiliation
Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendy S Rubinstein, MD, PhD
Organizational Affiliation
Evanston Northwestern Healthcare Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne M O'Neill, MA, MS, PhD
Organizational Affiliation
Evanston Northwestern Healthcare Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mack T Ruffin IV, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
American Academy of Family Physicians National Research Network (AAFP-NRN).
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Great Lakes Research into Practice Network (GRIN)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25901453
Citation
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.
Results Reference
derived
PubMed Identifier
22992357
Citation
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.
Results Reference
derived
PubMed Identifier
22257420
Citation
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.
Results Reference
derived
PubMed Identifier
21900440
Citation
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.
Results Reference
derived
PubMed Identifier
19460658
Citation
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.
Results Reference
derived

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Evaluating Tools for Health Promotion and Disease Prevention

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