We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00315978
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : July 10, 2007
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Disease Device: Heart-to-Heart Decision Aid Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial
Study Start Date : June 2003
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Discussion with provider about CHD risk reduction
  2. Stated plans for CHD risk reduction

Secondary Outcome Measures :
  1. Knowledge about CHD prevention
  2. Perception of CHD risk
  3. Interest in participating in decision-making

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315978


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Stacey L. Sheridan, MD, MPH University of North Carolina, Chapel Hill
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00315978    
Other Study ID Numbers: 03-MED-221
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: April 2006
Keywords provided by University of North Carolina, Chapel Hill:
Risk Assessment
Decision Support Technique
Physician-Patient Relations
Prevention and Control
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Heart Diseases