Back to resultsA Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COPD Inhaler Counseling
Usual Pharmacy Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility 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.
Sites / Locations
- UW-Madison School of Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
COPD Counseling Intervention
Usual Care
Arm Description
Pharmacist counseling intervention delivered via telephone.
Outcomes
Primary Outcome Measures
Adherence to daily inhaled COPD medications
Adherence will be measured by pharmacy refill records and by participant self-report
Secondary Outcome Measures
COPD exacerbations
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.
Full Information
NCT ID
NCT01270594
First Posted
January 3, 2011
Last Updated
May 26, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
William S. Middleton Memorial Veterans Hospital, American Society of Health-System Pharmacists
1. Study Identification
Unique Protocol Identification Number
NCT01270594
Brief Title
A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
Official Title
A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
William S. Middleton Memorial Veterans Hospital, American Society of Health-System Pharmacists
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD Counseling Intervention
Arm Type
Experimental
Arm Description
Pharmacist counseling intervention delivered via telephone.
Arm Title
Usual Care
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
COPD Inhaler Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Pharmacy Care
Intervention Description
The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.
Primary Outcome Measure Information:
Title
Adherence to daily inhaled COPD medications
Description
Adherence will be measured by pharmacy refill records and by participant self-report
Time Frame
Previous six months
Secondary Outcome Measure Information:
Title
COPD exacerbations
Description
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.
Time Frame
Previous six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Schuna, RPh MS
Organizational Affiliation
William S. Middleton Memorial Veterans Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW-Madison School of Pharmacy
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
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