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

October 21, 2016 updated by: University of Missouri-Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication adherence
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum cholesterol
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Todd Ruppar, PhD, RN, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU HSIRB 1174637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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