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NCT00393419 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00393419
Other study ID # 04-36002
Secondary ID
Status Completed
Phase N/A
First received October 26, 2006
Last updated October 26, 2006
Start date June 2004
Est. completion date August 2006

Study information
Verified date October 2006
Source Walter Reed Army Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• Comprehensive pharmacy care program

Locations
Country Name City State
United States Walter Reed Army Medical Center Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Walter Reed Army Medical Center American Society of Health-System Pharmacists

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in proportion of pills taken compared to baseline (0-2months) at 8months
Primary Between-group comparison of medication persistence at 14months
Secondary Change in blood pressure and low-density lipoprotein cholesterol at 8months
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