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

University of Missouri (MU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Medication Adherence; Hypercholesterolemia

Treatments: Behavioral: Attention-control; Behavioral: Medication adherence intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01227330

MU HSIRB 1174637

Details and patient eligibility

About

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.

Full 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?

Enrollment: 43 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 3 patient groups

Medication adherence intervention

Experimental group

Description:

Receives 12-week behavioral feedback intervention to improve adherence to statin medication

Treatment:

Behavioral: Medication adherence intervention

Control

No Intervention group

Description:

No intervention

Attention-control

Active Comparator group

Description:

Receives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol

Treatment:

Behavioral: Attention-control