Skip to main content
Clinical Trials/NCT00393419
NCT00393419
Completed
Not Applicable

Federal Study of Adherence to Medications in the Elderly (FAME)

Walter Reed Army Medical Center1 site in 1 country200 target enrollmentJune 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Walter Reed Army Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Change in proportion of pills taken compared to baseline (0-2months) at 8months
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.

Detailed Description

Poor medication adherence is prevalent, difficult to manage, and diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications which places them at increased risk for medication nonadherence. Effective strategies to improve adherence in the elderly are lacking, and improved health outcomes in this population have not been demonstrated. Objective: We tested the efficacy of a comprehensive pharmacy care program including patient education and an adherence aid (medications custom-packaged in blister packs) to improve medication adherence and its associated effects on blood pressure and low density lipoprotein cholesterol. This is a Multi-phase, prospective observational and randomized controlled trial. We enrolled community-based patients aged ≥ 65 years old taking ≥ 4 chronic medications per day. Intervention: After a 2-month run-in phase during which baseline medication adherence (via pill counts), blood pressure, and low-density lipoprotein cholesterol were measured, participants entered a 6-month intervention phase during which standardized medication education and regular follow-up by a clinical pharmacist was provided and medications were dispensed in daily, time-specific blister packs. Following the intervention phase, participants were randomized to continued pharmacy care/blister packs versus usual care (return to their original method of medication administration) for an additional 6 months. Main Outcome Measures: The primary endpoint of the observation phase was the change in the proportion of pills taken compared to baseline; secondary endpoints were the associated changes in low-density lipoprotein cholesterol and blood pressure. The primary endpoint of the randomized trial was the between-group comparison of medication persistence analyzed according to intention to treat.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
August 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 65 years or older taking 4 or more chronic medications independently living

Exclusion Criteria

  • assisted living or nursing home residents presence of any serious medical condition for which 1-year survival was expected to be unlikely

Outcomes

Primary Outcomes

Change in proportion of pills taken compared to baseline (0-2months) at 8months

Between-group comparison of medication persistence at 14months

Secondary Outcomes

  • Change in blood pressure and low-density lipoprotein cholesterol at 8months

Study Sites (1)

Loading locations...

Similar Trials