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

NCT ID: NCT01270594

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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COPD Counseling Intervention

Pharmacist counseling intervention delivered via telephone.

Group Type EXPERIMENTAL

COPD Inhaler Counseling

Intervention Type BEHAVIORAL

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.

Usual Care

Group Type OTHER

Usual Pharmacy Care

Intervention Type BEHAVIORAL

The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Pharmacy Care

The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William S. Middleton Memorial Veterans Hospital

FED

Sponsor Role collaborator

American Society of Health-System Pharmacists

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Schuna, RPh MS

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital

Locations

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UW-Madison School of Pharmacy

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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M-2010-1187

Identifier Type: -

Identifier Source: org_study_id

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