Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and
      it is important for people with these conditions to adhere to their medication regimens. This
      study will evaluate the effectiveness of a computerized program that provides individualized
      feedback to participants and their doctors for increasing medication adherence among people
      at risk of developing CVD.
    

Detailed description: 
      CVD is a disorder that affects the heart's ability to function normally. The most common
      cause of CVD is narrowing or blockage of the coronary arteries, which supply blood to the
      heart. There are many risk factors for CVD, including inflammation, high blood pressure, high
      cholesterol, and obesity. For people who take blood pressure and cholesterol lowering
      medications, adherence to their medication regimen is another important factor in reducing
      the risk of CVD. Currently, there are no programs available to assist patients with tracking
      their medication adherence, despite the fact that non-adherence is a major reason for
      elevated cholesterol and blood pressure levels. This study will evaluate a computerized
      medication adherence system (MAS) that provides individualized reports to participants and
      their doctors with information on identifying and overcoming barriers to medication
      adherence. The MAS will be evaluated in conjunction with counseling from participants'
      doctors. The purpose of this study is to evaluate the effectiveness of a computerized MAS
      plus counseling from doctors for increasing medication adherence and lowering blood pressure
      and cholesterol levels among people at risk of CVD.

      This 1-year study will enroll people with high blood pressure or cholesterol levels who are
      at risk of CVD. At a baseline study visit, participants will undergo blood pressure
      measurements, a blood collection, and a medication review. Participants will be randomly
      assigned to either the MAS group or a usual care group. Participants in the MAS group will
      use the computerized MAS program and answer questions about their medication regimens.
      Reports will then be generated for both the participants and their doctors. Participants will
      meet with their doctors to review the reports and discuss their medications and CVD risks.
      Participants in the usual care group will receive written materials on CVD risk factors, and
      they will receive usual care from their doctors. At a 6-month visit, participants in the MAS
      group will undergo a medication review, blood pressure measurements, and interviews with
      study staff. They will also enter their medication information into the MAS and meet with
      their doctors to discuss the generated report. Participants in the usual care group will not
      take part in any study procedures at 6 months. At a 12-month visit, all participants will
      undergo blood pressure measurements, a blood collection, and a medication review.
      Participants in the MAS group will also complete questionnaires to assess the usefulness of
      the MAS computer program.
    

Intervention name(s): Medication Adherence System (MAS); Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive individualized reports from the MAS and counseling from their doctors. The counseling will focus on adherence to blood pressure and cholesterol management medications.; Participants will receive usual care from their doctors and written materials on CVD risk factors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension; High Blood Pressure; Blood Lipid Management