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

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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

Tracking Information
First Submitted Date  ICMJE October 26, 2006
First Posted Date  ICMJE October 27, 2006
Last Update Posted Date October 27, 2006
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
  • Change in proportion of pills taken compared to baseline (0-2months) at 8months
  • Between-group comparison of medication persistence at 14months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
Change in blood pressure and low-density lipoprotein cholesterol at 8months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Federal Study of Adherence to Medications in the Elderly (FAME)
Official Title  ICMJE Federal Study of Adherence to Medications in the Elderly (FAME)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE
  • Medication Adherence
  • Hypertension
  • Hyperlipidemia
Intervention  ICMJE Behavioral: Comprehensive pharmacy care program
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 26, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393419
Other Study ID Numbers  ICMJE 04-36002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Walter Reed Army Medical Center
Collaborators  ICMJE American Society of Health-System Pharmacists
Investigators  ICMJE
Study Director: Allen J Taylor, MD Walter Reed Army Medical Center
Principal Investigator: Jeannie K Lee, Pharm.D Walter Reed Army Medical Center
PRS Account Walter Reed Army Medical Center
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP