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Evaluating a Web-Based Educational Program for Adults at Risk for Coronary Heart Disease (The Heart to Heart Feasibility Study)
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), November 2008
Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
The University of North Carolina, Chapel Hill
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00494052
  Purpose

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.


Condition Intervention
Coronary Disease
Cardiovascular Diseases
Behavioral: Heart to Heart (Web-Based Decision Aid)
Behavioral: Physician Education Session

MedlinePlus related topics: Coronary Artery Disease Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes [ Time Frame: Measured at the end of the study period (approximately 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Measured at participants' Month 3 study visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Heart to Heart intervention
Behavioral: Heart to Heart (Web-Based Decision Aid)
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.
Behavioral: Physician Education Session
A physician education session will be included in the program.
2: No Intervention
Usual care

Detailed Description:

CHD affects 13 million people in the United States. It is the leading cause of death in this country, and each year more than half a million Americans die from this disease. People who take steps to lower their cholesterol and blood pressure levels, lose weight, and stop smoking may be less likely to develop CHD. However, fewer than half of all individuals at risk for developing CHD follow these suggestions. Involving patients in the decision-making process regarding their medical care may improve their adherence to effective CHD prevention strategies. The goal of the Heart to Heart program is to provide information about CHD risk factors and encourage people to incorporate the appropriate risk-reduction measures into their lives. The purposes of this pilot study are to evaluate the ability of study researchers to recruit individuals with a moderate to high risk of CHD to participate in the study; to conduct a four-part CHD intervention (Heart to Heart) in a busy medical practice setting; and to measure participants' decision-making plans, self-reported adherence to medications, and changes in overall CHD risk factors. The results from this study will be used to guide future clinical trials.

This study will enroll patients being treated at the General Internal Medicine Clinic at the University of North Carolina at Chapel Hill who have a moderate to high risk of developing CHD. At an initial study visit, participants will complete questionnaires that assess CHD risk-reduction strategies, smoking status, and aspirin use. Blood pressure and cholesterol levels will also be measured. Participants will then be randomly assigned to either participate in the Heart to Heart intervention or receive usual care. 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. A Web-based coaching tool will encourage participants to talk with their doctor about risk-reduction choices. Participants will also receive brief adherence messages via the Web site 2, 4, and 6 weeks following their initial study visit. The messages will be designed to help participants adhere to their decisions. All participants will attend a study visit at Month 3 for repeat baseline testing. Following this visit, participants will receive a letter that includes their test results and their recalculated CHD risk. Participants may be contacted to take part in a focus group following the completion of the study.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494052

Contacts
Contact: Stacey L. Sheridan, MD, MPH 919-966-2276 sls593@med.unc.edu
Contact: Lindy Behrend, MPH 919-966-5796 lindy_behrend@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stacey L. Sheridan, MD, MPH     919-966-2276     sls593@med.unc.edu    
Contact: Lindy Behrend, MPH     919-966-5796     lindy_behrend@med.unc.edu    
Principal Investigator: Stacey L. Sheridan, MD, MPH            
Sub-Investigator: Ross J. Simpson, MD, PhD            
Sub-Investigator: Barbara K. Rimer, PhD            
Sub-Investigator: Michael P. Pignone, MD, MPH            
Sub-Investigator: Thomas C. Keyserling, MD, MPH            
Sub-Investigator: Russell P. Harris, MD, MPH            
UNC General Internal Medicine Clinic Recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
The University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Stacey L. Sheridan, MD, MPH The University of North Carolina, Chapel Hill
  More Information

Click here for the Heart to Heart Web site  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: University of North Carolina at Chapel Hill ( Stacey L. Sheridan, MD, MPH, Principal Investigator )
Study ID Numbers: 490, K23 HL074375-02
Study First Received: June 28, 2007
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00494052  
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Coronary Heart Disease
Choice Behavior
Risk Factors
Risk Assessment
Primary Prevention
Decision Making
Decision Aids
Patient Compliance

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009