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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01227330
First received: October 13, 2010
Last updated: October 21, 2016
Last verified: October 2016
  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.

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:


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 ]

Enrollment: 43
Study Start Date: October 2010
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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?
  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227330

Locations
United States, Missouri
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
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01227330     History of Changes
Other Study ID Numbers: MU HSIRB 1174637 
Study First Received: October 13, 2010
Last Updated: October 21, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 06, 2016