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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL074375-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Heart to Heart intervention |
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| 2 | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey L. Sheridan, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC General Internal Medicine Clinic | Chapel Hill | North Carolina | 27599 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17005051 | Background | 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. | |
| 22141447 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for the Heart to Heart Web site | View source |
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| Physician Education Session | Behavioral | A physician education session will be included in the program. |
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| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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