Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors
Clinic-based Intervention to Improve Medication Adherence to Reduce Cardiovascular Disease Risks
3 other identifiers
interventional
308
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cardiovascular-diseases
Started Dec 2008
Shorter than P25 for phase_2 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedApril 29, 2015
April 1, 2015
1.3 years
November 21, 2008
April 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence and associated changes in blood pressure and lipid profiles
Measured at Year 1
Study Arms (2)
1
EXPERIMENTALMedication adherence system (MAS) plus counseling from doctors
2
ACTIVE COMPARATORUsual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PHCC LPlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
PHCC LP
Pueblo, Colorado, 81003, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James G. Christian, MSW, MABS
PHCC LP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
December 1, 2008
Primary Completion
April 1, 2010
Study Completion
June 1, 2010
Last Updated
April 29, 2015
Record last verified: 2015-04