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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) The University of North Carolina, Chapel Hill |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00494052 |
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 |
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Coronary Disease Cardiovascular Diseases |
Behavioral: Heart to Heart (Web-Based Decision Aid) Behavioral: Physician Education Session |
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 |
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 |
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1: Experimental
Heart to Heart intervention
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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.
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2: No Intervention
Usual care
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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.
Ages Eligible for Study: | 40 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Stacey L. Sheridan, MD, MPH | The University of North Carolina, Chapel Hill |
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 |
Coronary Heart Disease Choice Behavior Risk Factors Risk Assessment |
Primary Prevention Decision Making Decision Aids Patient Compliance |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |