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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227330
• Other study ID #: MU HSIRB 1174637
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 13, 2010
• Last updated: October 21, 2016
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Medication Adherence

Intervention

Behavioral:
• Medication adherence intervention
12-week behavioral feedback intervention to improve adherence to statin medication
• Attention-control
Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence		6 months	No
Secondary	Serum cholesterol		6 months	No