Hypercholesterolemia, Medication Adherence
Conditions
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.
Detailed description
This study will answer the following primary research question: 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?
Interventions
BEHAVIORALMedication adherence intervention
12-week behavioral feedback intervention to improve adherence to statin medication
BEHAVIORALAttention-control
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Participant's medications are managed by someone other than the participant * Participant is unable or unwilling to use MEMS caps.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication adherence | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Serum cholesterol | 6 months |
Countries
United States
Outcome results
None listed