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

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00315978
First received: April 17, 2006
Last updated: July 9, 2007
Last verified: April 2006
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 University of North Carolina, Chapel Hill
  More Information

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

Publications:

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

Keywords provided by University of North Carolina, Chapel Hill:
Risk Assessment
Decision Support Technique
Physician-Patient Relations
Prevention and Control

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013