Evaluating a Web-Based Educational Program for Adults at Risk for Coronary Heart Disease (The Heart to Heart Feasibility Study)
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|ClinicalTrials.gov Identifier: NCT00494052|
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : January 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Cardiovascular Diseases||Behavioral: Heart to Heart (Web-Based Decision Aid) Behavioral: Physician Education Session||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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.
No Intervention: 2
- 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) ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494052
|United States, North Carolina|
|UNC General Internal Medicine Clinic|
|Chapel Hill, North Carolina, United States, 27599|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Stacey L. Sheridan, MD, MPH||University of North Carolina, Chapel Hill|