NCT00315978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
Last Updated

July 10, 2007

Status Verified

April 1, 2006

First QC Date

April 17, 2006

Last Update Submit

July 9, 2007

Conditions

Cardiovascular Disease

Keywords

Risk AssessmentDecision Support TechniquePhysician-Patient RelationsPrevention and Control

Outcome Measures

Primary Outcomes (2)

  • Discussion with provider about CHD risk reduction

  • Stated plans for CHD risk reduction

Secondary Outcomes (3)

  • Knowledge about CHD prevention

  • Perception of CHD risk

  • Interest in participating in decision-making

Interventions

Heart-to-Heart Decision AidDEVICE

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presenting for routine medical care with regular medical provider
  • able to understand, speak, and read English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related 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. doi: 10.1186/1472-6963-6-121.

    PMID: 17005051RESULT

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Stacey L. Sheridan, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 19, 2006

Study Start

June 1, 2003

Study Completion

February 1, 2004

Last Updated

July 10, 2007

Record last verified: 2006-04

Locations

US(1)