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A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
William S. Memorial Veterans Hospital
American Society of Health-System Pharmacists
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01270594
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler adherence in veterans with COPD who have demonstrated poor inhaler adherence through pharmacy refill records?

Veterans who receive who receive daily maintenance inhalers from the William S Middleton Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80% over the previous six months will be invited to participate in the study. This study will randomize 100 participants to a usual care arm or a pharmacist counseling intervention. Final data collection will be six months after randomization to determine if both self-reported and refill record adherence has changed.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Behavioral: COPD Inhaler Counseling
Behavioral: Usual Pharmacy Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Adherence to daily inhaled COPD medications [ Time Frame: Previous six months ] [ Designated as safety issue: No ]
    Adherence will be measured by pharmacy refill records and by participant self-report


Secondary Outcome Measures:
  • COPD exacerbations [ Time Frame: Previous six months ] [ Designated as safety issue: No ]
    Participants will be asked how many episodes of worsening their COPD has required additional medical care and/or the use of an oral steroid or antibiotic.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPD Counseling Intervention
Pharmacist counseling intervention delivered via telephone.
Behavioral: COPD Inhaler Counseling
The counseling will be performed via telephone by a pharmacist at the William S Middleton Memorial Veterans Hospital. The counseling will include education about inhaled COPD medication, inhaler technique review, reminder tools, and motivational interviewing.
No Intervention: Usual Care Behavioral: Usual Pharmacy Care
The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female veterans established with the William S. Middleton Memorial Veterans Hospital and associated Community Based Outpatient Clinics
  • Fill their inhaled COPD medications with the VHA
  • A diagnosis of COPD and an active prescription for a twice daily long-acting beta-agonist and/or long-acting anticholinergic with or without a prescription for inhaled corticosteroids for at least 4 months.
  • Non-adherence to at least one COPD medication, a medication possession ratio of less than 80% or over 120% via the pharmacy refill records.

Exclusion Criteria:

  • Patients with a diagnosis or electronic medical record note regarding significant hearing impairment.
  • Patients with a diagnosis regarding cognitive deficit and activated power of attorney.
  • Patients who use daily nebulization instead of inhalers for maintenance medication.
  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: NCT01270594

Contacts
Contact: Amanda Margolis, Pharm D (608) 890-0434 arpitterle@wisc.edu

Locations
United States, Wisconsin
UW-Madison School of Pharmacy Recruiting
Madison, Wisconsin, United States, 53705
Contact: Margolis    608-890-0434      
Sponsors and Collaborators
University of Wisconsin, Madison
William S. Memorial Veterans Hospital
American Society of Health-System Pharmacists
Investigators
Principal Investigator: Arthur Schuna, RPh MS William S Middleton Memorial Veterans Hospital
  More Information

No publications provided

Responsible Party: Arthur Schuna, Principle Investigator, William S Middleton Memorial Veterans Hospital
ClinicalTrials.gov Identifier: NCT01270594     History of Changes
Other Study ID Numbers: M-2010-1187
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014