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Completed

NCT Number: NCT01227330

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

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.

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Key information

Conditions

Hypercholesterolemia Behavior Dyslipidemias Health Behavior Hyperlipidemias Lipid Metabolism Disorders Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medication adherence intervention

Behavioral

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

Attention-control

Behavioral

Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group

Primary outcomes

  1. Medication adherence

    Time frame: 6 months

Secondary outcomes

  1. Serum cholesterol

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Oct 25, 2010
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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