The Impact of Patient Involvement in Decision-Making About Heart Disease Prevention - Full Text View

Sponsored by:	University of North Carolina
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00315978

Purpose

The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.

Condition	Intervention
Cardiovascular Disease	Device: Heart-to-Heart Decision Aid

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Discussion with provider about CHD risk reduction
Stated plans for CHD risk reduction

Secondary Outcome Measures:

Knowledge about CHD prevention
Perception of CHD risk
Interest in participating in decision-making

Estimated Enrollment:	120
Study Start Date:	June 2003
Estimated Study Completion Date:	February 2004

Detailed Description:

Background: Low utilization of effective CHD prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients’ discussions with their doctor and their plans for CHD prevention.

Methods: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor.

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

presenting for routine medical care with regular medical provider
able to understand, speak, and read English

Exclusion Criteria:

prior history of cardiovascular disease
history of serious medical illness that would limit candidacy for screening
previous participation in intensive risk modification as part of diabetes study in our clinic
no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315978

Locations

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina

Investigators

Principal Investigator:

Stacey L. Sheridan, MD, MPH

The University of North Carolina, Chapel Hill

More Information

Heart-to-Heart webtool (version 1) tested in research protocol This link exits the ClinicalTrials.gov site

Publications of Results:

Sheridan SL, Shadle J, Simpson RJ Jr, Pignone MP. The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial. BMC Health Serv Res. 2006 Sep 27;6:121.

Study ID Numbers:	03-MED-221
Study First Received:	April 17, 2006
Last Updated:	July 9, 2007
ClinicalTrials.gov Identifier:	NCT00315978
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Risk Assessment
Decision Support Technique
Physician-Patient Relations
Prevention and Control

Study placed in the following topic categories:

Coronary Disease
Heart Diseases
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009