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

This study has been completed.
Information provided by:
University of North Carolina, Chapel Hill Identifier:
First received: April 17, 2006
Last updated: July 9, 2007
Last verified: April 2006
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
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial

Resource links provided by NLM:

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.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00315978

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
Principal Investigator: Stacey L. Sheridan, MD, MPH University of North Carolina, Chapel Hill
  More Information

Publications: Identifier: NCT00315978     History of Changes
Other Study ID Numbers: 03-MED-221
Study First Received: April 17, 2006
Last Updated: July 9, 2007

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
Heart Diseases processed this record on August 22, 2017