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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00796172
First received: November 21, 2008
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Behavioral: Medication Adherence System (MAS)
Behavioral: Usual Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Medication adherence and associated changes in blood pressure and lipid profiles [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 308
Study Start Date: December 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Usual care
Behavioral: Usual Care
Participants will receive usual care from their doctors and written materials on CVD risk factors.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796172

Locations
United States, Colorado
PHCC LP
Pueblo, Colorado, United States, 81003
Sponsors and Collaborators
Investigators
Principal Investigator: James G. Christian, MSW, MABS PHCC LP
  More Information

No publications provided

Responsible Party: James G. Christian, MSW, MABS, PHCC LP
ClinicalTrials.gov Identifier: NCT00796172     History of Changes
Other Study ID Numbers: 601, 2 R44 HL090111-02
Study First Received: November 21, 2008
Last Updated: July 21, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Hypertension
High Blood Pressure
Blood Lipid Management

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014