Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
NCT ID: NCT01227330
Last Updated: 2016-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2010-10-31
2014-02-28
Brief Summary
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Detailed Description
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1. What is the estimated effect size of a behavioral MA intervention on MA rates in older adults who are poorly adherent to statin medications?
The study will also explore the following secondary research questions:
2. What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults?
3. What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults?
4. What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medication adherence intervention
Receives 12-week behavioral feedback intervention to improve adherence to statin medication
Medication adherence intervention
12-week behavioral feedback intervention to improve adherence to statin medication
Control
No intervention
No interventions assigned to this group
Attention-control
Receives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol
Attention-control
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
Interventions
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Medication adherence intervention
12-week behavioral feedback intervention to improve adherence to statin medication
Attention-control
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
Eligibility Criteria
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Inclusion Criteria
* Take a once-daily prescription statin medication for ≥ 6 months with no changes to statin prescription for at least 30 days prior to study entry,
* A score of ≤ 9 on the Short Blessed Test,
* Participants must self-administer his or her own medications without prompts from any other person or device.
* Baseline medication adherence rate of ≤ 90%.
* Participants agree to complete all study contacts and measurements, including the use of a special medication bottle with a Medication Event Monitoring System (MEMS) cap for the duration of the study.
* Able to open and close MEMS caps.
Exclusion Criteria
* Participant is unable or unwilling to use MEMS caps.
60 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Principal Investigators
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Todd Ruppar, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri
Columbia, Missouri, United States
Countries
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Other Identifiers
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MU HSIRB 1174637
Identifier Type: -
Identifier Source: org_study_id
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