Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000432617
Ethics application status
Approved
Date submitted
27/03/2023
Date registered
28/04/2023
Date last updated
28/04/2023
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
StudyU: a new tool to self manage chronic pain
Scientific title
The feasibility of digital self-management treatments for chronic non-cancer pain through personalised behavioural experiments
Secondary ID [1] 309388 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 329458 0
Condition category
Condition code
Anaesthesiology 326392 326392 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A list of potential interventions, all available locally at no or low cost to the participant, includes:
• Walking program set up during visit to physiotherapist or exercise physiologist (on Chronic Disease Management Plan)
• Healthy Ageing Group Exercise
• Online CBT eg MindSpot
• Meditation – eg smiling mind app
• Pain neuroscience education eg Curable app
• Gym program
• Yoga program
• Pilates
• Aquarobics
• Hydrotherapy classes
• Tai chi.
This is delivered for 6-12 weeks at a frequency chosen by the patient. Participants may choose up to 2 interventions each to be undertaken over a 6-12 week period until November 2023.

StudyU (https://play.google.com/store/apps/details?id=health.studyu) is an innovative online self-management treatment platform—it allows patients to rigorously compare different pain management interventions using gold-standard N-of-1 trials (personalised single patient behavioural experiments), empowering them to adopt interventions that help their pain most.
The StudyU mobile App will support patients to assess the effect of the nonpharmacological pain self-management intervention. The exact intervention components, design features and timeframes for interventions and washout periods will be decided through each patient’s design consultation with the study team. The length of the baseline and the treatment period will differ depending on the intervention selected. We have designed an example from our pilot work: If a patient selects an intervention e.g. a 5 week exercise program to trial over an 8-week period using a Single Case Experimental Design (SCED) design, then a 1 week A – 5 week B – 2 week A design would be used.
- interventions will be delivered by health professionals or trained instructors
- the mode of delivery can be face-to-face, group, individual, or online, depending on patient preference
- most programs eg the gym program, involves weekly 1 h classes for 6 consecutive weeks
- the actual intervention will be selected by the patient and their GP in a consultation
- participants can undertake only one intervention at any one time, but may test another intervention after finishing their trial if they wish
- strategies used to assess or monitor adherence include participant self report daily.
- internal app analytics will monitor fidelity to the intervention.
Intervention code [1] 325727 0
Behaviour
Comparator / control treatment
Control is their usual routine.
Control group
Active

Outcomes
Primary outcome [1] 334248 0
Number of participants recruited and retained (number of treatment trials completed) determined by an audit of study enrolment/withdrawal logs
Timepoint [1] 334248 0
End of study
Primary outcome [2] 334460 0
baseline/post-intervention response rates determined by an audit of log that records response status
Timepoint [2] 334460 0
end of study
Primary outcome [3] 334461 0
satisfaction with treatment trial and StudyU determined by structured qualitative interviews
Timepoint [3] 334461 0
end of study
Secondary outcome [1] 419968 0
Usability - simplified System Usability Scale Questionnaire
Timepoint [1] 419968 0
End of study
Secondary outcome [2] 419969 0
Acceptability - Unified Theory of Acceptance and Use of Technology scales Effort Expectancy, Social Influence, Hedonic Motivations, Habit, Facilitating Conditions, and Behavioural Intention
Timepoint [2] 419969 0
End of study

Eligibility
Key inclusion criteria
1) >18 years, 2) experiencing clinically significant chronic pain (current average pain severity >4 measured on the Pain Visual Analog Scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: 1) acute mental health disorder or suicidal, 2) unable to use digital health apps because of low literacy, impaired vision or dexterity, impaired cognition 3) non-English speaking, 4) no smartphone (Android and iPhones) access, 5) no Internet access, 6) currently receiving active non-pharmacological pain treatment program (e.g., psychological therapy; physiotherapy) from a health professional [patients will be invited to participate once they finish their block of therapy], 7) unstable on regular pain medications over the past month (ie they have to have been on a stable dose of regular pain medication for at least 4 weeks prior to the trial (and will remain on this during the trial). (This does not apply to additional pain medication).

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



Intervention assignment
Other
Other design features
Single Case Experimental Design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility outcomes will be summarised using descriptive statistics. Preliminary clinical effectiveness analysis will include change in scores on pain-related interference (primary outcome) at 4 weeks follow-up compared to baseline. We will also compare average pain-related interference and severity across all days in baseline, and average across all days in treatment phase. Additionally, we will examine change in secondary outcome measures at 8 weeks, and at 4 weeks follow-up compared to baseline measure scores. Using Bayesian techniques, these analyses will be performed both on the individual level for each study participant, and also on the aggregated level across all participants. Analyses will be overseen by CIs McDonald and Konigorski.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2023
Actual
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 313483 0
Commercial sector/Industry
Name [1] 313483 0
Health Hub Morayfield REEC Committee
Country [1] 313483 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia Brisbane 4029 QLD
Country
Australia
Secondary sponsor category [1] 315257 0
None
Name [1] 315257 0
Address [1] 315257 0
Country [1] 315257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312674 0
The University of Queensland Medical Research Committee
Ethics committee address [1] 312674 0
Ethics committee country [1] 312674 0
Australia
Date submitted for ethics approval [1] 312674 0
01/03/2023
Approval date [1] 312674 0
21/03/2023
Ethics approval number [1] 312674 0
2023/HE 000039

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

Contacts
Principal investigator
Name 125518 0
A/Prof Jane Nikles
Address 125518 0
Recover Injury Research Centre The University of Queensland Herston 4029
Country 125518 0
Australia
Phone 125518 0
+61408599033
Fax 125518 0
Email 125518 0
[email protected]
Contact person for public queries
Name 125519 0
Jane Nikles
Address 125519 0
Recover Injury Research Centre The University of Queensland Herston 4029
Country 125519 0
Australia
Phone 125519 0
+61408599033
Fax 125519 0
Email 125519 0
[email protected]
Contact person for scientific queries
Name 125520 0
Jane Nikles
Address 125520 0
Recover Injury Research Centre The University of Queensland Herston 4029
Country 125520 0
Australia
Phone 125520 0
+61408599033
Fax 125520 0
Email 125520 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.