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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00393419
Enrollment
200
Registered
2006-10-27
Start date
2004-06-30
Completion date
2006-08-31
Last updated
2006-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hypertension, Medication Adherence

Keywords

hypertension, hyperlipidemia, adherence, pharmacist, elderly, medication

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.

Interventions

BEHAVIORALComprehensive pharmacy care program

Sponsors

American Society of Health-System Pharmacists
CollaboratorOTHER
Walter Reed Army Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in proportion of pills taken compared to baseline (0-2months) at 8months
Between-group comparison of medication persistence at 14months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026