NCT00494052

Brief Summary

Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer than half of all individuals at risk for CHD take advantage of proven strategies to lower their chances of developing this disease. This study will assess the effectiveness of Heart to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction strategies into their lives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

June 28, 2007

Last Update Submit

January 25, 2013

Conditions

Coronary DiseaseCardiovascular Diseases

Keywords

Coronary Heart DiseaseChoice BehaviorRisk FactorsRisk AssessmentPrimary PreventionDecision MakingDecision AidsPatient Compliance

Outcome Measures

Primary Outcomes (1)

  • Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes

    Measured at the end of the study period (approximately 2 years)

Secondary Outcomes (1)

  • Self-reported use of any new CHD risk reduction strategy; global CHD risk; blood pressure; serum total cholesterol and HDL-c levels; smoking status; aspirin use; self-reported plans for CHD risk reduction; self-efficacy for CHD risk reduction

    Measured at participants' Month 3 study visit

Study Arms (2)

1

EXPERIMENTAL

Heart to Heart intervention

Behavioral: Heart to Heart (Web-Based Decision Aid)Behavioral: Physician Education Session

2

NO INTERVENTION

Usual care

Interventions

Heart to Heart (Web-Based Decision Aid)BEHAVIORAL

Participants in the intervention group will access Heart to Heart, a Web site designed to educate them about their overall CHD risk, specific risk factors, and strategies and preferences for risk reduction.

1
Physician Education SessionBEHAVIORAL

A physician education session will be included in the program.

1

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently a patient at the General Internal Medicine Clinic at the University of North Carolina at Chapel Hill
  • Moderate (6% to 20%) or high (greater than 20%) risk of CHD, as defined by current evidence and practice-based guidelines for aspirin use and cholesterol levels

You may not qualify if:

  • Known cardiovascular disease (e.g., previous heart attack, previous coronary artery bypass graft or percutaneous coronary intervention, angina, previous transient ischemic attack \[TIA\] or stroke, peripheral vascular disease, congestive heart failure)
  • Diabetes
  • Low global risk of CHD (less than 6%)
  • Dementia or other severe cognitive dysfunction
  • Blindness
  • Serious medical illness that would make the individual a poor candidate for the study (e.g., kidney failure, liver cirrhosis, HIV, non-skin cancer, any other illness for which their life expectancy is projected at less than 5 years)
  • Inability to speak and understand English
  • Participation in the preliminary study or in cognitive testing of intervention components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNC General Internal Medicine Clinic

Chapel Hill, North Carolina, 27599, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

  • 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: 17005051BACKGROUND

  • Sheridan SL, Draeger LB, Pignone MP, Keyserling TC, Simpson RJ Jr, Rimer B, Bangdiwala SI, Cai J, Gizlice Z. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies. BMC Health Serv Res. 2011 Dec 5;11:331. doi: 10.1186/1472-6963-11-331.

    PMID: 22141447DERIVED

Related Links

MeSH Terms

Conditions

Coronary DiseaseCardiovascular DiseasesPatient Compliance

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stacey L. Sheridan, MD, MPH

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

US(2)