Familial risk assessment and personalized prevention messages in Stroke and Diabetes and Breast Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Familial risk assessment and personalized prevention messages

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 Type

Interventional

Enrollment (Anticipated)

8400

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Evanston, Illinois, United States, 60201
    - Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices
- Kansas
  - Leawood, Kansas, United States, 66211
    - American Academy of Family Physicians National Research Network (AAFP-NRN).
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Great Lakes Research into Practice Network (GRIN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

University of Michigan

Case Western Reserve University

American Academy of Family Physicians National Research Network

Evanston Northwestern Healthcare Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria