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

Primary Purpose

Hypercholesterolemia, Medication Adherence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Medication adherence intervention
Attention-control
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Medication adherence intervention

Control

Attention-control

Arm Description

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

No intervention

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

Outcomes

Primary Outcome Measures

Medication adherence

Secondary Outcome Measures

Serum cholesterol

Full Information

First Posted
October 13, 2010
Last Updated
October 21, 2016
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01227330
Brief Title
Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
Official Title
Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Medication Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication adherence intervention
Arm Type
Experimental
Arm Description
Receives 12-week behavioral feedback intervention to improve adherence to statin medication
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Attention-control
Arm Type
Active Comparator
Arm Description
Receives visits on the same schedule as the intervention group, with health education that is unrelated to medications or cholesterol
Intervention Type
Behavioral
Intervention Name(s)
Medication adherence intervention
Intervention Description
12-week behavioral feedback intervention to improve adherence to statin medication
Intervention Type
Behavioral
Intervention Name(s)
Attention-control
Intervention Description
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
Primary Outcome Measure Information:
Title
Medication adherence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum cholesterol
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Ruppar, PhD, RN
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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