Evaluating a Web-Based Educational Program for Adults at Risk for Coronary Heart Disease (The Heart to Heart Feasibility Study)
Condition: Coronary Disease; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Coronary Disease
Study type: Interventional

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.
    

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.
    

Intervention name(s): Heart to Heart (Web-Based Decision Aid); Physician Education Session
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 physician education session will be included in the program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Coronary Heart Disease; Choice Behavior; Risk Factors; Risk Assessment; Primary Prevention; Decision Making; Decision Aids; Patient Compliance