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
PO Box 5013 Wellington 6140
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
New Zealand has a high number of people with asthma and this is often not managed well causing days off work, school, or other activities. With a shortage of GPs and long wait times for a doctor’s appointment, many people do not seek asthma information or disease management services.

Pharmacists are available as a great source of information about asthma medicines, triggers, disease management and advice for staying healthy, however are often not used. We would like to investigate the introduction of a new asthma service in the community pharmacy to help people better manage their asthma.

This study has been designed with input from patients, GPs, nurses and pharmacists. We are looking at the feasibility of providing this service in a community pharmacy. We will be asssessing the acceptability of the service to both patients and health care professionals.

The study requires monthly communication between patients with asthma and the pharmacist. Conversations with the pharmacist / pharmacy technician will include asthma education, medication use, assessment of asthma control, asthma plans and what may to help control asthma.
At the end of the study we will gain feedback to help us assess the feasibility of the study,
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
alesha.smith@otago.ac.nz
Contact person for public queries
Name 131283 0
A/Prof 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
alesha.smith@otago.ac.nz
Contact person for scientific queries
Name 131284 0
A/Prof 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
alesha.smith@otago.ac.nz

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.