Evaluating Tools for Health Promotion a… | Clinical Trial

Key information

Conditions

Coronary Heart Disease Adnexal Diseases Brain Diseases Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Colonic Diseases Colorectal Cancer Colorectal Neoplasms Coronary Disease Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glucose Metabolism Disorders Gonadal Disorders Heart Diseases Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Myocardial Ischemia Neoplasms Neoplasms by Site Nervous System Diseases Nutritional and Metabolic Diseases Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Stroke Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices, Evanston, Illinois, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Familial risk assessment and personalized prevention messages

Behavioral

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

American Academy of Family Physicians National Research Network
Case Western Reserve University
Evanston Northwestern Healthcare Research Institute
University of Michigan

Registry information

Important dates

Study start: 2005
Study completion: 2007
First posted: Sep 14, 2005
Registry last updated: Jan 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed