Chronic Obstructive Pulmonary DiseasePhase 2NCT01270594
A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
A Phase 2 study testing COPD Inhaler Counseling and Usual Pharmacy Care in people with Chronic Obstructive Pulmonary Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD Inhaler Counseling and Usual Pharmacy Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UW-Madison School of Pharmacy
Madison, Wisconsin, 53705
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD Inhaler Counseling, Usual Pharmacy Care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD Inhaler CounselingBehavioural
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 CareBehavioural
The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.
| Study group | Role | What they receive |
|---|---|---|
| COPD Counseling Intervention | Experimental | Pharmacist counseling intervention delivered via telephone. Receives: Behavioral: COPD Inhaler Counseling |
| Usual Care | Other | Not described Receives: Behavioral: Usual Pharmacy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to daily inhaled COPD medications
Adherence will be measured by pharmacy refill records and by participant self-report
Measured: Previous six months
Secondary outcomes (1)
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.
Measured: Previous six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- William S. Middleton Memorial Veterans Hospital, American Society of Health-System Pharmacists
- Responsible party
- Sponsor
- Investigators
- Arthur Schuna, RPh MS, Principal investigator, William S. Middleton Memorial Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270594
- Sponsor's protocol ID
- M-2010-1187
- Status last verified
- May 2015
- First submitted
- 3 Jan 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD
- ClinicalTrials.gov ID
- NCT01270594
- Acronym / sponsor ID
- M-2010-1187
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- William S. Middleton Memorial Veterans Hospital, American Society of Health-System Pharmacists
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Counseling Intervention | Experimental | Behavioral: COPD Inhaler CounselingPharmacist counseling intervention delivered via telephone. |
| Usual Care | Other | Behavioral: Usual Pharmacy Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD Inhaler CounselingThe 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. | Behavioural | COPD Counseling Intervention |
| Usual Pharmacy CareThe usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists. | Behavioural | Usual Care |
Primary outcome
Adherence to daily inhaled COPD medications
Time frame: Previous six months
Adherence will be measured by pharmacy refill records and by participant self-report
1 secondary outcome
COPD exacerbations
Time frame: Previous six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Schuna, RPh MS principal investigator
William S. Middleton Memorial Veterans Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COPD Inhaler Counseling and Usual Pharmacy Care in people with Chronic Obstructive Pulmonary Disease, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to daily inhaled COPD medications (time frame: Previous six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.