Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000938707p
Ethics application status
Not yet submitted
Date submitted
24/06/2022
Date registered
1/07/2022
Date last updated
1/07/2022
Date data sharing statement initially provided
1/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Our Recovery – Feasibility of a consumer-led, evidence-based online program for self-management of chronic pain in the community
Scientific title
Our Recovery – Feasibility of a consumer-led, evidence-based online program for self-management of chronic pain in the community
Secondary ID [1] 307308 0
2022802
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 326598 0
Condition category
Condition code
Anaesthesiology 323844 323844 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (Our Recovery) is an online, peer-led support program for people living with chronic pain. It consists of 4 components:
1. ‘Features of Recovery’ resources: qualitative research detailing the experiences of people living well with pain will be translated into accessible formats for the community and discussed during group sessions. The information will be presented in the form of single page pdf documents available for download from the website.
2. Group sessions: structured 1 hour meetings for no more than 20 people with chronic pain to connect with each other, share experiences, and gain insights into living well with chronic pain. 5 group sessions will be available each week for the 9 months of the study, however attendance is at the discretion of the participant.
3. Peer-coaching: trained peer supporters will provide 30 minute 1-to-1 coaching support sessions to help people understand their pain experience and plan their own recovery. There will be 30 peer coaching sessions available each week, and these will run for the 9 months of the study. Attendance is at the discretion of the participant.
4. Self-directed modules: based on Acceptance and Commitment Therapy (ACT) principles these modules will encourage self-reflection and support behaviour change. It is likely that 6-8 modules will be developed. Modules can be accessed through the website, and progressed through at the participant's own pace ie. there is no predetermined rate of engagement. Modules will consist of a series of 6-8 ACT concepts as applied to the context of chronic pain, using text and accompanying visual illustrations. Participants will be asked to provide a written reflection to that concept in relation to their own lived experience of pain in a free text box at the end of each module. Modules will be take approximately 30 minutes to complete each, and will be accessible for the 9 months of the study period.

The program will be delivered by peers with lived experience of chronic pain, who have undergone training in providing peer support.

The study will have a 6 month recruitment window, and run for 9 months. Participants can access the various program offerings (individual sessions, group sessions, self directed modules) as little or as often as they like during the 9 month period.

Participants will access the program via the study website only. The Our Recovery website has been created (https://www.ourrecovery.org.au/) however the materials and content will be designed as part of this study.

Website analytics will be used to gather information on program engagement, and session attendance data will be taken from the Zoom platform.
Intervention code [1] 323758 0
Behaviour
Intervention code [2] 323893 0
Treatment: Other
Comparator / control treatment
The control condition is usual care for individuals with chronic pain. Usual care typically includes physiotherapy/chiropractic/osteopathy, medication, and massage treatment. Participants in the usual care control group will be provided access to the intervention upon completion of data collection at 9 months post-enrolment.
Control group
Active

Outcomes
Primary outcome [1] 331801 0
Treatment feasibility will be assessed by the following combination of data analytics and brief self-report questionnaire:
a) Consent to randomisation - proportion of people referred to the study who enrol in the study
b) Recruitment rate - number of people enrolled in the study per month
c) Program engagement - engagement frequency (average number of modules completed, number of group and individual sessions attended per month). Gathered from platform hosting analytics
d) Treatment satisfaction - questionnaire response to 5 items on aspects of the program (ease of use, content, format, accessibility, overall satisfaction) rated on 0-10 Numerical Rating Scale
Timepoint [1] 331801 0
3 months after study commencement (primary endpoint) and 9 months after study commencement
Secondary outcome [1] 411222 0
Pain-related interference will be assessed using the Brief Pain Inventory
Timepoint [1] 411222 0
Baseline, 3 months after study commencement, 9 months after study commencement
Secondary outcome [2] 411288 0
Self efficacy will be assessed using the Pain Self-Efficacy Questionnaire
Timepoint [2] 411288 0
Baseline, 3 months post-study commencement, and 9 months post-study commencement
Secondary outcome [3] 411289 0
Sense of coherence will be assessed using the Sense of Coherence Scale
Timepoint [3] 411289 0
Baseline, 3 months post-study commencement, and 9 months post-study commencement
Secondary outcome [4] 411290 0
Quality of life will be assessed using the EuroQol 5 questionnaire
Timepoint [4] 411290 0
Baseline, 3 months post-study commencement, 9 months post-study commencement
Secondary outcome [5] 411291 0
Mood will be assessed using the Depression, Anxiety, Stress Scale-21
Timepoint [5] 411291 0
Baseline, 3 months post-study commencement, 9 months post-study commencement

Eligibility
Key inclusion criteria
Adults with chronic pain who have accessed multidisciplinary pain treatment within 3 months of their referral to the program.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Awaiting invasive treatment for pain [e.g. Dorsal Column Stimulation (DCS), surgery]; oral morphine equivalent daily dose > 100mg; mental health condition requiring urgent intervention; involvement in a third party claim

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Research Randomizer program (www.randomizer.org)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data
For the treatment satisfaction measures, we will estimate a) means for continuous variables (program engagement, treatment satisfaction), and b) proportions for binary variable (consent to randomisation, recruitment rate) with a 95% confidence interval (with Wilson Score interval with continuity correction for binary measures). We will consider feasibility to be reached if: a) 70% of participants consent to be randomised; and b) treatment satisfaction scores > 7/10.

Continuous data will be summarised with means and standard deviation, or medians and IQR as appropriate. Categorical data will be summarised with counts and proportions. For the main outcomes, no multiplicity adjustment will be used. To demonstrate feasibility, both measures will need to meet the pre-defined thresholds in the Our Recovery arm. To compare continuous measures between the study arms, two-group t-test or GLMM will be used along with estimation of mean difference and 95% confidence interval. We will use multiple imputation (using key participant variables in the imputation model) and determine the appropriate number of imputations based on the fraction of missing information. Analyses will be intention-to-treat, with a=0.05. A statistical analysis plan will be prepared before the database is locked.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 22614 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 22615 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 22616 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 22653 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 22654 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [6] 22655 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 37879 0
3050 - Parkville
Recruitment postcode(s) [2] 37880 0
2305 - New Lambton
Recruitment postcode(s) [3] 37881 0
2031 - Randwick
Recruitment postcode(s) [4] 37928 0
2065 - St Leonards
Recruitment postcode(s) [5] 37929 0
3199 - Frankston
Recruitment postcode(s) [6] 37930 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 311606 0
Government body
Name [1] 311606 0
Medical Research Foundation Fund (NHMRC)
Country [1] 311606 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 313038 0
None
Name [1] 313038 0
Address [1] 313038 0
Country [1] 313038 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311047 0
UTS HREC
Ethics committee address [1] 311047 0
Ethics committee country [1] 311047 0
Australia
Date submitted for ethics approval [1] 311047 0
03/04/2023
Approval date [1] 311047 0
Ethics approval number [1] 311047 0

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

Contacts
Principal investigator
Name 119810 0
Prof Toby Newton-John
Address 119810 0
University of Technology Sydney
PO Box 123
Sydney NSW 2007
Country 119810 0
Australia
Phone 119810 0
+61 02 9514 7241
Fax 119810 0
Email 119810 0
[email protected]
Contact person for public queries
Name 119811 0
Toby Newton-John
Address 119811 0
University of Technology Sydney
PO Box 123
Sydney NSW 2007
Country 119811 0
Australia
Phone 119811 0
+61 02 9514 7241
Fax 119811 0
Email 119811 0
[email protected]
Contact person for scientific queries
Name 119812 0
Toby Newton-John
Address 119812 0
University of Technology Sydney
PO Box 123
Sydney NSW 2007
Country 119812 0
Australia
Phone 119812 0
+61 02 9514 7241
Fax 119812 0
Email 119812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified participant data collected during the trial
When will data be available (start and end dates)?
Following publication, no end date determined
Available to whom?
Researchers who provide a sound justification; at the discretion of the Primary Sponsor
Available for what types of analyses?
Only to achieve the aims of the approved proposal.
How or where can data be obtained?
By contacting the Principal Sponsor via email: [email protected]


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.