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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315978
• Other study ID #: 03-MED-221
• Status: Completed
• Phase: N/A
• First received: April 17, 2006
• Last updated: July 9, 2007
• Start date: June 2003
• Est. completion date: February 2004

Study information

• Verified date: April 2006
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Diseases

Intervention

Device:
• Heart-to-Heart Decision Aid

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discussion with provider about CHD risk reduction
Primary	Stated plans for CHD risk reduction
Secondary	Knowledge about CHD prevention
Secondary	Perception of CHD risk
Secondary	Interest in participating in decision-making