Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
Condition: Cardiovascular Disease; Coronary Heart Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of
      death in the US. Every year, more than one million Americans have a heart attack, and nearly
      800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than
      $316 billion in health care and lost productivity.

      Both lifestyle changes and medication can reduce the risk of CVD, and this project combines
      these approaches in the hopes of identifying a practical intervention for use in primary care
      medical offices. The project combines two previously tested interventions and updates them to
      meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs
      (statins).

      The research team is delivering the combined intervention in two formats: web-based and
      counselor-based. Each format has the same content, but the web-based advice is accessed
      through the Internet by clients at home, a community site, or a primary care office. The
      other format involves sessions delivered to clients by a counselor either in person at a
      primary care office or over the telephone. The researchers will compare how effective each
      format is in reducing participants' risk of coronary heart disease. They will also determine
      the interventions' effect on participants' diet, physical activity, smoking status,
      medication adherence, and other health indicators. In addition, the team will compare the two
      formats' cost-effectiveness and how well the patients, office staff, and clinicians accept
      the interventions.

      Recruited from five family practices, 600 patients representing the geographic and ethnic
      diversity of North Carolina are taking part in this study. Half the participants are randomly
      assigned to the web-based intervention; the other half to the counselor-based version. Both
      groups will also get information on local resources, such as gyms and farmers markets, that
      can help participants maintain a healthy lifestyle.
    


Intervention name(s): Lifestyle and medication intervention
Intervention type(s): Behavioral
Intervention description(s): The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence). The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diet interventions; Physical activity interventions; Medication adherence; Tailored interventions