NCT01270594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

January 3, 2011

Last Update Submit

May 26, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Adherence to daily inhaled COPD medications

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

    Previous six months

Secondary Outcomes (1)

  • COPD exacerbations

    Previous six months

Study Arms (2)

COPD Counseling Intervention

EXPERIMENTAL

Pharmacist counseling intervention delivered via telephone.

Behavioral: COPD Inhaler Counseling

Usual Care

OTHER
Behavioral: Usual Pharmacy Care

Interventions

COPD Inhaler CounselingBEHAVIORAL

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.

COPD Counseling Intervention
Usual Pharmacy CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW-Madison School of Pharmacy

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arthur Schuna, RPh MS

    William S. Middleton Memorial Veterans Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 5, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

April 1, 2012

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)