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

July 9, 2007 updated by: University of North Carolina

Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

120

Phase

  • Not Applicable

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

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of North Carolina

Investigators

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

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

June 1, 2003

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2007

Last Update Submitted That Met QC Criteria

July 9, 2007

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-MED-221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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