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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393419
Recruitment Status : Completed
First Posted : October 27, 2006
Last Update Posted : October 27, 2006
Sponsor:
Collaborator:
American Society of Health-System Pharmacists
Information provided by:
Walter Reed Army Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Medication Adherence Hypertension Hyperlipidemia Behavioral: Comprehensive pharmacy care program Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Federal Study of Adherence to Medications in the Elderly (FAME)
Study Start Date : June 2004
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in proportion of pills taken compared to baseline (0-2months) at 8months
  2. Between-group comparison of medication persistence at 14months

Secondary Outcome Measures :
  1. Change in blood pressure and low-density lipoprotein cholesterol at 8months

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393419


Locations
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United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
American Society of Health-System Pharmacists
Investigators
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Study Director: Allen J Taylor, MD Walter Reed Army Medical Center
Principal Investigator: Jeannie K Lee, Pharm.D Walter Reed Army Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00393419    
Other Study ID Numbers: 04-36002
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: October 27, 2006
Last Verified: October 2006
Keywords provided by Walter Reed Army Medical Center:
hypertension
hyperlipidemia
adherence
 pharmacist
elderly
medication
Additional relevant MeSH terms:
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Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
 Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases