Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
1 other identifier
interventional
43
1 country
1
Brief Summary
The purpose of this study is to pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2010
Typical duration for phase_1
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
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedOctober 24, 2016
October 1, 2016
3.2 years
October 13, 2010
October 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Medication adherence
6 months
Secondary Outcomes (1)
Serum cholesterol
6 months
Study Arms (3)
Medication adherence intervention
EXPERIMENTALReceives 12-week behavioral feedback intervention to improve adherence to statin medication
Control
NO INTERVENTIONNo intervention
Attention-control
ACTIVE COMPARATORReceives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol
Interventions
12-week behavioral feedback intervention to improve adherence to statin medication
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
Eligibility Criteria
You may qualify if:
- Age 60 or older at the time of study entry,
- 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.
You may not qualify if:
- Participant's medications are managed by someone other than the participant
- Participant is unable or unwilling to use MEMS caps.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri
Columbia, Missouri, 65211, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Ruppar, PhD, RN
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 25, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2013
Study Completion
February 1, 2014
Last Updated
October 24, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share