Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors

Cardiovascular Diseases Clinical Trial

Official title:

Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796172
• Other study ID #: 601
• Secondary ID: R44HL0901112R44H
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2008
• Last updated: April 27, 2015
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: April 2015
• Source: PHCC LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Prescribed one or more antihypertensive and/or lipid management medications

• Living independently

• Has a literacy level that will enable them to successfully navigate the MAS and read associated reports (i.e., approximately a sixth grade reading level)

Exclusion Criteria:

• Current substance use or abuse

• Recent (in the 6 months before study entry) heart attack, stroke, peripheral vascular disease, or other medical condition that limits a potential participant's ability to complete the necessary visits to the outpatient clinic site, to use the MAS, and to complete study assessments

• Residing in assisted living or a nursing home situation

• Medical condition for which survival is expected to be unlikely in the 1 year after study entry

• Unable to read or use a computer with a computer mouse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.
• Usual Care
Participants will receive usual care from their doctors and written materials on CVD risk factors.

Locations

Country	Name	City	State
United States	PHCC LP	Pueblo	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
PHCC LP	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence and associated changes in blood pressure and lipid profiles		Measured at Year 1	No