Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000120370
Ethics application status
Approved
Date submitted
26/02/2008
Date registered
5/03/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding respiratory medication persistence in Australian patients with chronic obstructive pulmonary disease
Scientific title
Understanding respiratory medication persistence in Australian patients with chronic obstructive pulmonary disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 2875 0
Condition category
Condition code
Respiratory 3012 3012 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an innovative project, utilising a largely untapped health resource - community pharmacists and their computerised prescription data - to help identify patients with chronic obstructive pulmonary disease (COPD) as evidenced by their use of Spiriva (tiotropium). The project objective is to understand the drivers and barriers of persistence with respiratory medication, specifically Spiriva.
A software application that extracts data from the market leading pharmacy dispensing software system in Australia (WiniFRED Dispense; PCA/NU Systems), developed by the research team, will be modified to identify patients with COPD as evidenced by use of Spiriva. Community pharmacies throughout Tasmania will be recruited and will install the application. In one pass through the complete data set the dispensing history will be interrogated and a list of patients (who are aged over 40 years or age is unknown) identified as having received Spiriva in the previous 12-month period will be generated. Patients will be identified as “persistent” (those to whom Spiriva was dispensed at least nine times in the preceding 12-month period, including at least two units in the past 90 days) or “non-persistent” (those for whom Spiriva was dispensed between one and four times (inclusive) in the preceding six-month period, with nil dispensings in the subsequent 65 days). The participating pharmacist will examine the dispensing information for each patient identified and will be able to exclude patients from being sent an invitation to participate if they believe the patient is aged under 40 years, is residing in an aged care facility, is deceased, is significantly cognitively impaired and would not understand the letter, or would be alarmed excessively by receiving the letter and participating in the project. Patients deemed suitable for inclusion will be sent a letter by the community pharmacist, to invite them to participate, along with patient information sheets and consent forms.
All consenting patients will be subsequently sent questionnaires by the researchers, assessing anxiety and depression, illness perception, health-related quality of life, and medication adherence. Half of the patients will participate in qualitative interviews addressing patient characteristics, diagnosis, treatment choice, day-to-day management, fulfillment, and persistence with therapy. Project deliverables will include utilising key dispensing information to identify key barriers and predictors of poor persistence to Spiriva, and the development of belief/behaviour maps for identified patients, leading to a clear set of recommendations regarding persistence triggers amongst patient types.
Intervention code [1] 2605 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3894 0
Identification of key barriers and predictors of poor persistence to Spiriva (tiotropium).
Quantitative measures: St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Illness Perception Questionnaire, Beliefs about Medicines Questionnaire.
Qualitative measures: approximately half of the participants will also participate in qualitative face-to-face interviews. These interviews will fully explore, using the therapeutic buying process as an organising framework (i.e. origination ? diagnosis ? treatment choice/practice? fulfilment ? persistence?).
Timepoint [1] 3894 0
At the end of the study - September 2008.
Secondary outcome [1] 6578 0
N/A
Timepoint [1] 6578 0
N/A

Eligibility
Key inclusion criteria
- Persistent patients: those to whom Spiriva was dispensed at least nine times in the preceding 12-month period, including at least two units in the past 90 days.
- Non-persistent patients: those to whom Spiriva was dispensed between one and four times (inclusive) in the preceding six-month period, with nil dispensings in the subsequent 65 days after the last Spiriva dispensing. Such patients would also have had nil Spiriva dispensed in the 12 months preceding the first dispensing of Spiriva.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who
- Are aged under 40 years,
- Are residing in an aged care facility,
- Are deceased,
- Are significantly cognitively impaired and would not understand the letter, and/or
Would be alarmed excessively by receiving the letter and participating in the study. (Based on the community pharmacist's knowledge of the patient)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3126 0
Commercial sector/Industry
Name [1] 3126 0
Boehringer Ingelheim Pty Ltd
Country [1] 3126 0
Australia
Primary sponsor type
University
Name
Unit for Medication Outcomes Research and Education, School of Pharmacy, University of Tasmania
Address
University of Tasmania
Churchill Avenue
Sandy Bay
Private Bag 83
Hobart TAS 7001
Country
Australia
Secondary sponsor category [1] 2812 0
Other
Name [1] 2812 0
P Group Reasearch Pty Ltd
Address [1] 2812 0
94 Quinns Parade
PO Box 402
Mt Eliza VIC 3930
Country [1] 2812 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5101 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 5101 0
Ethics committee country [1] 5101 0
Australia
Date submitted for ethics approval [1] 5101 0
19/12/2007
Approval date [1] 5101 0
14/02/2008
Ethics approval number [1] 5101 0
H0009842

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28404 0
Address 28404 0
Country 28404 0
Phone 28404 0
Fax 28404 0
Email 28404 0
Contact person for public queries
Name 11561 0
Bonnie Bereznicki
Address 11561 0
Churchill Avenue Shandy Bay
Private Bag 83
Hobart TAS 7001
Country 11561 0
Australia
Phone 11561 0
+61 3 62262191
Fax 11561 0
+61 3 62267627
Email 11561 0
[email protected]
Contact person for scientific queries
Name 2489 0
Bonnie Bereznicki
Address 2489 0
Churchill Avenue Shandy Bay
Private Bag 83
Hobart TAS 7001
Country 2489 0
Australia
Phone 2489 0
+61 3 62262191
Fax 2489 0
+61 3 62267627
Email 2489 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.