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OpenTrials
Completed

NCT Number: NCT01270594

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UW-Madison School of Pharmacy

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COPD Inhaler Counseling

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 Pharmacy Care

Behavioral

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

Primary outcomes

  1. Adherence to daily inhaled COPD medications

    Time frame: Previous six months

    Adherence will be measured by pharmacy refill records and by participant self-report

Secondary outcomes

  1. COPD exacerbations

    Time frame: Previous six months

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • American Society of Health-System Pharmacists
  • William S. Middleton Memorial Veterans Hospital

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 5, 2011
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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