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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01227330
First received: October 13, 2010
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  Purpose

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.

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?

Condition Intervention Phase
Hypercholesterolemia
Medication Adherence
 Behavioral: Medication adherence intervention
Behavioral: Attention-control
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227330

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65211
Contact: Todd Ruppar, PhD, RN     573-884-5153     ruppart@missouri.edu    
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Todd Ruppar, PhD, RN University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Todd Ruppar, PhD, RN, University of Missouri
ClinicalTrials.gov Identifier: NCT01227330     History of Changes
Other Study ID Numbers: MU HSIRB 1174637
Study First Received: October 13, 2010
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013