Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000053527
Ethics application status
Approved
Date submitted
15/12/2023
Date registered
23/01/2024
Date last updated
23/01/2024
Date data sharing statement initially provided
23/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility study for a peer support program for early career community pharmacists focusing on understanding and managing the emotional impact of significant events – Protocol for a longitudinal study
Scientific title
Feasibility study for a peer support program for early career community pharmacists focusing on understanding and managing the emotional impact of significant events – Protocol for a longitudinal study
Secondary ID [1] 311192 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace-related stress 332369 0
Depression 332370 0
Anxiety 332371 0
Condition category
Condition code
Mental Health 329077 329077 0 0
Anxiety
Mental Health 329078 329078 0 0
Depression
Public Health 329079 329079 0 0
Health service research
Mental Health 329238 329238 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomly allocated to the intervention group will be invited to take part in monthly peer support meetings, which will take place online via Zoom. These meetings are expected to last between 45 and 60 minutes in duration, and will occur on a monthly basis for twelve months in total. Each group will contain a peer support facilitator who has been trained via Hand-N-Hand Peer Support prior to commencement of the study. There will be six participants in total in each group, including the facilitator. The content of the meetings will be guided by the facilitator, but is expected to be centered around workplace practices, relationships and stress.

Adherence will be noted from meeting attendance. It is recommended that participants attend all meetings, but ultimately these are voluntary and the choice to engage in or attend each meeting will be at the discretion of each individual participant.

The Hand-N-Hand Peer Support training completed by facilitators consists of an online training session run by the organisation that takes places over three hours.
Intervention code [1] 327640 0
Treatment: Other
Comparator / control treatment
No treatment is given to those in the control group. They continue working in the community pharmacy field as normal.
Control group
Active

Outcomes
Primary outcome [1] 336893 0
To test the feasibility of an Early Career Pharmacist-led peer support program in Australia. This is a composite primary outcome.
Timepoint [1] 336893 0
12 months post-study commencement
Secondary outcome [1] 430062 0
Early Career Pharmacists' perspectives of a peer support program for their cohort, including barriers and enablers to the program as experienced by participants and facilitators. This is a composite secondary outcome.
Timepoint [1] 430062 0
12 months post study commencement
Secondary outcome [2] 430073 0
Depression, anxiety and stress
Timepoint [2] 430073 0
Baseline (month 0), 3, 6, 9, and 12 months after study commencement
Secondary outcome [3] 430074 0
Job satisfaction
Timepoint [3] 430074 0
Baseline (month 0), 3, 6, 9 and 12 months post study commencement

Eligibility
Key inclusion criteria
- Less than ten years of experience working under general registration with the Pharmacy Board of Australia
- Currently employed in an Australian community pharmacy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Undergraduate pharmacy students and intern pharmacists
- Pharmacists with more than ten years of experience working with general registration
- Pharmacists who are not currently working in community pharmacy, including those who are currently on extended periods of leave eg parental leave
- Any participants who are exhibiting active symptoms of severe, unmanaged mental illness including depression, anxiety, bipolar disorder and schizophrenia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation conducted by computer software (random number generator)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size was kept low due to the trial being a feasibility study rather than an efficacy study.
Data will be described as frequencies, percentages, means and standard deviations. Categorical data from survey responses will be analysed using a cross-tabulation analysis method. Chi-square tests will be used to compare binary outcomes, and T-tests will be used for continuous outcomes.
Thematic analysis will be conducted on qualitative data provided from the end-of-study or exit surveys..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/01/2024
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
56
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315451 0
Government body
Name [1] 315451 0
Australian Government Department of Education
Country [1] 315451 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
North Terrace, Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 317523 0
Charities/Societies/Foundations
Name [1] 317523 0
Pharmaceutical Society of Australia
Address [1] 317523 0
Suite 7/1-2 Greenhill Road, Unley South Australia 5061
Country [1] 317523 0
Australia
Other collaborator category [1] 282899 0
Charities/Societies/Foundations
Name [1] 282899 0
Hand-N-Hand Peer Support
Address [1] 282899 0
http://www.handnhand.org.au
Country [1] 282899 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314361 0
University of South Australia Human Research Ethics Comittee
Ethics committee address [1] 314361 0
Ethics committee country [1] 314361 0
Australia
Date submitted for ethics approval [1] 314361 0
16/10/2023
Approval date [1] 314361 0
07/11/2023
Ethics approval number [1] 314361 0
205704

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

Contacts
Principal investigator
Name 131314 0
Miss Maria Cooper
Address 131314 0
University of South Australia, City West Campus, Corner of Morphett Street and North Terrace, Adelaide SA 5000
Country 131314 0
Australia
Phone 131314 0
+61 414144020
Fax 131314 0
Email 131314 0
[email protected]
Contact person for public queries
Name 131315 0
Maria Cooper
Address 131315 0
University of South Australia, City West Campus, Corner of Morphett Street and North Terrace, Adelaide SA 5000
Country 131315 0
Australia
Phone 131315 0
+61 414144020
Fax 131315 0
Email 131315 0
[email protected]
Contact person for scientific queries
Name 131316 0
Maria Cooper
Address 131316 0
University of South Australia, City West Campus, Corner of Morphett Street and North Terrace, Adelaide SA 5000
Country 131316 0
Australia
Phone 131316 0
+61 414144020
Fax 131316 0
Email 131316 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


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.