Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000404527p
Ethics application status
Submitted, not yet approved
Date submitted
14/12/2023
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the feasibility of a new model of care in pharmacy for the self-management of asthma
Scientific title
Assessing the feasibility of a new model of care in pharmacy for the self-management of asthma
Secondary ID [1] 311182 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 332360 0
Condition category
Condition code
Respiratory 329068 329068 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An education service will be tested in a pharmacy-based clinic for people with asthma who are between 5-50 years of age. This will be provided by pharmacists and/or pharmacy technicians,
Patients with asthma will be provided with education about their inhalers, triggers, ways to manage their asthma. The resources used will be a combination of information sheets and asthma management tools frequently used in primary care in NZ. The education session time is flexible - and education can occur anytime during the trial at patient's request.
Intervention code [1] 327628 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336873 0
Acceptability of education (composite outcome)
Timepoint [1] 336873 0
3 months post enrolment
Secondary outcome [1] 429994 0
Feasibility of pharmacy-based education service (composite)
Timepoint [1] 429994 0
3 months post enrolment

Eligibility
Key inclusion criteria
• Patients with asthma 5-50 years of age (without COPD)
• Parents and caregivers of children on asthma inhalers
• Ability to speak and understand English
Minimum age
5 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cannot communicate in english
- Diagnosis of COPD

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 26036 0
New Zealand
State/province [1] 26036 0

Funding & Sponsors
Funding source category [1] 315440 0
University
Name [1] 315440 0
University of Otago
Country [1] 315440 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Frederick St, Dunedin
Country
New Zealand
Secondary sponsor category [1] 317510 0
None
Name [1] 317510 0
Address [1] 317510 0
Country [1] 317510 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314352 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314352 0
Ethics committee country [1] 314352 0
New Zealand
Date submitted for ethics approval [1] 314352 0
18/03/2024
Approval date [1] 314352 0
Ethics approval number [1] 314352 0

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

Contacts
Principal investigator
Name 131282 0
A/Prof Alesha Smith
Address 131282 0
18 Fredrick St, University of Otago, Dunedin, Otago, 9010
Country 131282 0
New Zealand
Phone 131282 0
+64 212229711
Fax 131282 0
Email 131282 0
[email protected]
Contact person for public queries
Name 131283 0
Alesha Smith
Address 131283 0
18 Fredrick St, University of Otago, Dunedin, Otago, 9010
Country 131283 0
New Zealand
Phone 131283 0
+64 212229711
Fax 131283 0
Email 131283 0
[email protected]
Contact person for scientific queries
Name 131284 0
Alesha Smith
Address 131284 0
18 Fredrick St, University of Otago, Dunedin, Otago, 9010
Country 131284 0
New Zealand
Phone 131284 0
+64 212229711
Fax 131284 0
Email 131284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be from the patients active health record and will not be shared


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.