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

This study has been completed.
Sponsor:
Collaborator:
American Society of Health-System Pharmacists
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00393419
First received: October 26, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 Intervention
Medication Adherence
Hypertension
Hyperlipidemia
Behavioral: Comprehensive pharmacy care program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Federal Study of Adherence to Medications in the Elderly (FAME)

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

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

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

Estimated Enrollment: 200
Study Start Date: June 2004
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393419

Locations
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
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00393419     History of Changes
Other Study ID Numbers: 04-36002
Study First Received: October 26, 2006
Last Updated: October 26, 2006
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
hypertension
hyperlipidemia
adherence
pharmacist
elderly
medication

Additional relevant MeSH terms:
Hypertension
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014