Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults

Study Overview
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Brief Summary
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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
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This study will answer the following primary research question: 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: What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults? What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults? What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?

Official Title
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Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults

Conditions
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Hypercholesterolemia, Medication Adherence

Intervention / Treatment
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* Behavioral: Medication adherence intervention
* Behavioral: Attention-control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication adherence intervention<br>Receives 12-week behavioral feedback intervention to improve adherence to statin medication | Behavioral: Medication adherence intervention<br>* 12-week behavioral feedback intervention to improve adherence to statin medication<br>|
| No Intervention: Control<br>No intervention | |
| Active Comparator: Attention-control<br>Receives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol | Behavioral: Attention-control<br>* Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cholesterol |  | 6 months |