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

Phase 1

Completed

• Conditions: Medication Adherence; Hypercholesterolemia
• Interventions: Behavioral: Medication adherence intervention; Behavioral: Attention-control

• Registration Number: NCT01227330
• Lead Sponsor: University of Missouri-Columbia

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?

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication adherence intervention	Medication adherence intervention	Receives 12-week behavioral feedback intervention to improve adherence to statin medication
Attention-control	Attention-control	Receives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol

Primary Outcome Measures

Name	Time	Method
Medication adherence	6 months

Secondary Outcome Measures

Name	Time	Method
Serum cholesterol	6 months

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States