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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
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Scientific title
The feasibility of digital self-management treatments for chronic non-cancer pain through personalised behavioural experiments
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Secondary ID [1]
309388
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic pain
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Condition category
Condition code
Anaesthesiology
326392
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
325727
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Behaviour
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Comparator / control treatment
Control is their usual routine.
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Control group
Active
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Outcomes
Primary outcome [1]
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Number of participants recruited and retained (number of treatment trials completed) determined by an audit of study enrolment/withdrawal logs
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Assessment method [1]
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Timepoint [1]
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End of study
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Primary outcome [2]
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baseline/post-intervention response rates determined by an audit of log that records response status
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Assessment method [2]
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Timepoint [2]
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end of study
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Primary outcome [3]
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satisfaction with treatment trial and StudyU determined by structured qualitative interviews
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Assessment method [3]
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Timepoint [3]
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end of study
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Secondary outcome [1]
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Usability - simplified System Usability Scale Questionnaire
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Assessment method [1]
419968
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Timepoint [1]
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End of study
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Secondary outcome [2]
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Acceptability - Unified Theory of Acceptance and Use of Technology scales Effort Expectancy, Social Influence, Hedonic Motivations, Habit, Facilitating Conditions, and Behavioural Intention
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Assessment method [2]
419969
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Timepoint [2]
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End of study
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Single Case Experimental Design
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/05/2023
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Actual
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Date of last participant enrolment
Anticipated
1/10/2023
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Actual
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Date of last data collection
Anticipated
15/12/2023
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Health Hub Morayfield REEC Committee
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Address [1]
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19-31 Dickson Rd Morayfield 4509 QLD
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
St Lucia Brisbane 4029 QLD
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Queensland Medical Research Committee
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Ethics committee address [1]
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St Lucia Brisbane 4029 QLD
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/03/2023
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Approval date [1]
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21/03/2023
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Ethics approval number [1]
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2023/HE 000039
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Summary
Brief summary
Our project aims to co-design, develop and test feasibility of a digital, personalised self-management intervention for reducing pain-related disability in each individual patient with chronic pain. StudyU (https://play.google.com/store/apps/details?id=health.studyu.me) 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 strategies that help the most.
In previous work, CI Konigorski and his team developed StudyU, a general-use platform and mobile App for researchers and physicians to design N-of-1 trials for chronic conditions and patients to carry out these personalised experiments. We will tailor StudyU specifically to patients with chronic pain, and with improved features that allow patients to create and run their own personalised experiments to determine which non-pharmacological management strategies improve their daily functioning.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Jane Nikles
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Address
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Recover Injury Research Centre
The University of Queensland
Herston 4029
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Country
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Australia
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Phone
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+61408599033
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Jane Nikles
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Address
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Recover Injury Research Centre
The University of Queensland
Herston 4029
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Country
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Australia
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Phone
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+61408599033
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Jane Nikles
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Address
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Recover Injury Research Centre
The University of Queensland
Herston 4029
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Country
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Australia
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Phone
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+61408599033
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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