The Impact of Patient Involvement in Decision-Making Abou... | NCT00315978

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

NCT00315978

Sponsor

University of North Carolina

Status

Completed

Last Update Posted

Jul 10, 2007Estimated

Enrollment

120

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

Heart-to-Heart Decision Aid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Feb 2004

First Submitted Date

Apr 17, 2006

First Submission Date that Met QC Criteria

Apr 17, 2006

First Posted Date

Apr 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2007

Last Update Posted Date

Jul 10, 2007Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Heart-to-Heart Decision Aid	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discussion with provider about CHD risk reduction
Stated plans for CHD risk reduction

Secondary Outcomes

Measure	Description	Time Frame
Knowledge about CHD prevention
Perception of CHD risk
Interest in participating in decision-making

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stacey L. Sheridan, MD, MPH	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina at Chapel Hill		Chapel Hill	North Carolina	27599	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17005051	Result	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.