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Completed

NCT Number: NCT00393419

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

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.

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Key information

Conditions

Medication Adherence Behavior Cardiovascular Diseases Dyslipidemias Health Behavior Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Comprehensive pharmacy care program

Behavioral

Primary outcomes

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

  2. Between-group comparison of medication persistence at 14months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Walter Reed Army Medical Center

Fed

Collaborators

  • American Society of Health-System Pharmacists

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Oct 27, 2006
Registry last updated
Oct 27, 2006

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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