Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors
|ClinicalTrials.gov Identifier: NCT00796172|
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : April 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Medication Adherence System (MAS) Behavioral: Usual Care||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||June 2010|
Medication adherence system (MAS) plus counseling from doctors
Behavioral: Medication Adherence System (MAS)
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.
Active Comparator: 2
Behavioral: Usual Care
Participants will receive usual care from their doctors and written materials on CVD risk factors.
- Medication adherence and associated changes in blood pressure and lipid profiles [ Time Frame: Measured at Year 1 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796172
|United States, Colorado|
|Pueblo, Colorado, United States, 81003|
|Principal Investigator:||James G. Christian, MSW, MABS||PHCC LP|