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

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT01227330
Collaborator
(none)
43
Enrollment
1
Location
3
Arms
40
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Medication adherence intervention
  • Behavioral: Attention-control
 Phase 1/Phase 2

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:

  1. What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults?

  2. What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults?

  3. What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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
No Intervention: Control

No intervention
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

Outcome Measures

Primary Outcome Measures

  1. Medication adherence [6 months]

Secondary Outcome Measures

  1. Serum cholesterol [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Missouri Columbia Missouri United States 65211

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01227330
Other Study ID Numbers:
  • MU HSIRB 1174637
First Posted:
Oct 25, 2010
Last Update Posted:
Oct 24, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Hypercholesterolemia

Study Results

No Results Posted as of Oct 24, 2016