Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001112550
Ethics application status
Approved
Date submitted
8/08/2024
Date registered
16/09/2024
Date last updated
16/09/2024
Date data sharing statement initially provided
16/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
What do you think of THRIVE | Whakapuawai as a peer support group for those living with inflammatory arthritis?
Scientific title
A pilot study of THRIVE | Whakpuawai: A peer support group for people with inflammatory arthritis
Secondary ID [1] 312700 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Arthritis 334736 0
Condition category
Condition code
Inflammatory and Immune System 331296 331296 0 0
Rheumatoid arthritis
Inflammatory and Immune System 331297 331297 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
THRIVE | Whakapuawai is a co-designed peer support group that focused on sharing and learning from each other’s experiences with inflammatory arthritis. It will focus the discussion on topics that have been identified as important by the co-design team to living well with inflammatory arthritis. The topics include:
- Tips and tricks (talking about strategies for pain, fatigue and flare-ups)
- Healthy habits (talking about helpful lifestyle actions)
- Resources and decisions (talking about medication, other treatments, and where to get information you can trust)
- Impacts (talking about managing impacts on mood and stress)
- Voice (talking about communicating well with health professionals and the people in your life)
- Enjoyment (talking about finding and doing what brings you joy)

Each group will consist of 8 individuals, 6 peer participants and 2 co-facilitators (one health professional and one peer living with inflammatory arthritis). The sessions will be conducted in a hybrid format (Zoom or in-person) and consist of semi-structured discussions around the above topics. There is a total of 6 sessions, with each scheduled to run for one hour per fortnight over 12 weeks.

All THRIVE | Whakapuawai facilitators will receive training delivered by the research team at least a month prior to the commencement of THRIVE | Whakapuawai. It will be delivered over the course of two four-hour sessions in a hyrbid format (Zoom and in-person).

We will be utilising an attendance checklist as part of our feasibility measurement.
Intervention code [1] 329236 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339050 0
Feasibility and acceptability of THRIVE | Whakapuawai
Timepoint [1] 339050 0
Throughout THRIVE | Whakapuawai programme via brief focus groups after each of the 6 sessions and 3-4 weeks following completion of THRIVE | Whakapuawai programme
Secondary outcome [1] 439290 0
Nill
Timepoint [1] 439290 0
Nill

Eligibility
Key inclusion criteria
• Be 18+ years of age
• Able to converse in English without an interpreter
• Have a diagnosis of any type of inflammatory arthritis (eg. Rheumatoid arthritis, psoriatic arthritis, lupus, etc.)
• Living in the Canterbury or West Coast region
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Significant visual or hearing impairment to an extent that would make engagement in a group environment difficult
• Only have diagnosis of osteoarthritis (OA) without other inflammatory arthritis diagnosis

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
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
1/10/2024
Actual
Date of last participant enrolment
Anticipated
25/10/2024
Actual
Date of last data collection
Anticipated
28/03/2025
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 26495 0
New Zealand
State/province [1] 26495 0
Canterbury

Funding & Sponsors
Funding source category [1] 317133 0
Charities/Societies/Foundations
Name [1] 317133 0
Canterbury Arthritis Support Trust
Country [1] 317133 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Burwood Academy Trust
Address
Country
New Zealand
Secondary sponsor category [1] 319400 0
None
Name [1] 319400 0
Address [1] 319400 0
Country [1] 319400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315885 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315885 0
Ethics committee country [1] 315885 0
New Zealand
Date submitted for ethics approval [1] 315885 0
03/07/2024
Approval date [1] 315885 0
05/08/2024
Ethics approval number [1] 315885 0
2024 EXP 19750

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

Contacts
Principal investigator
Name 136094 0
Dr Kalie Evans
Address 136094 0
Burwood Academy Trust Private Bag 4708 Christchurch 8140
Country 136094 0
New Zealand
Phone 136094 0
+64 210 919 6871
Fax 136094 0
Email 136094 0
[email protected]
Contact person for public queries
Name 136095 0
Dr Kalie Evans
Address 136095 0
Burwood Academy Trust Private Bag 4708 Christchurch 8140
Country 136095 0
New Zealand
Phone 136095 0
+64 210 919 6871
Fax 136095 0
Email 136095 0
[email protected]
Contact person for scientific queries
Name 136096 0
Dr Kalie Evans
Address 136096 0
Burwood Academy Trust Private Bag 4708 Christchurch 8140
Country 136096 0
New Zealand
Phone 136096 0
+64 210 919 6871
Fax 136096 0
Email 136096 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
Confidentiality of participants in study on basis of informed consent


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.