Federal Study of Adherence to Medications in the Elderly (FAME) - Full Text View

Sponsors and Collaborators:	Walter Reed Army Medical Center American Society of Health-System Pharmacists
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00393419

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

MedlinePlus related topics: Cholesterol High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	Federal Study of Adherence to Medications in the Elderly (FAME)

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

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:

Blackburn DF, Dobson RT, Blackburn JL, Wilson TW. Cardiovascular morbidity associated with nonadherence to statin therapy. Pharmacotherapy. 2005 Aug;25(8):1035-43.

Abughosh SM, Kogut SJ, Andrade SE, Larrat P, Gurwitz JH. Persistence with lipid-lowering therapy: influence of the type of lipid-lowering agent and drug benefit plan option in elderly patients. J Manag Care Pharm. 2004 Sep-Oct;10(5):404-11.

Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002 Jul 24-31;288(4):462-7.

Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. 2005 Jun;43(6):521-30.

Publications indexed to this study:

Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. Epub 2006 Nov 13.

Study ID Numbers:	04-36002
Study First Received:	October 26, 2006
Last Updated:	October 26, 2006
ClinicalTrials.gov Identifier:	NCT00393419
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

hypertension
hyperlipidemia
adherence

pharmacist
elderly
medication

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Vascular Diseases
Metabolic disorder

Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009