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

NCT ID: NCT00315978

Last Updated: 2007-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Interventions

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Heart-to-Heart Decision Aid

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina

OTHER

Sponsor Role lead

Principal Investigators

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Stacey L. Sheridan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17005051 (View on PubMed)

Related Links

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http://www.med-decisions.com/H2HV2

Heart-to-Heart webtool (version 1) tested in research protocol

Other Identifiers

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03-MED-221

Identifier Type: -

Identifier Source: org_study_id