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Trial registered on ANZCTR


Registration number
ACTRN12624000459527
Ethics application status
Approved
Date submitted
1/03/2024
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Embedding digitally enabled, single case experiments in general practice to support self-management and shared decision-making with patients with persistent pain
Scientific title
Embedding digitally enabled, single case experiments in general practice to support self-management and shared decision-making with patients with persistent pain
Secondary ID [1] 311852 0
Integrating StudyU, a new tool to self-manage persistent pain, in general practice settings
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
persistent pain 333102 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329790 329790 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Personalised, non-drug single case experimental design trials of self-managed activity chosen by patient from a list of options available locally and affordable for the patient. The list of suggested options will be revised at intervals during the study to ensure it is updated and options remain available at the time of patient enrolment. We will not pre-specify a particular list of options in this protocol as we expect availability to change over the course of the study, and options suggested by the patient will also be considered if suitable. Options are likely to include group or individual walking programs, chair yoga, park Tai Chi, mindfulness practice, personalised exercise program, online pain management module, and online cognitive-behavioural therapy. None of these activities is designed specifically for the study, and all are publicly available, with the exception of a personalised exercise program (which is likely to require an exercise physiologist or physiotherapist assessment and prescription). Online options are openly accessible and ideally free of charge. Some activities may be sponsored by local government or councils. The patient's GP will indicate suitable options for the patient. The list will also be reviewed at intervals by a physiotherapist with expertise in persistent pain, who is a member of the research team. Specific examples of online options recommended by the physiotherapist include MindSpot via https://www.mindspot.org.au/treatment/our-courses/pain-course/, SmilingMind via https://www.smilingmind.com.au/smiling-mind-app, and myWhiplash Navigator via https://mywhiplash.com.au/. A brief description of these options is as follows: MIndSpot is a self-guided course including 5 lessons with the option of online, weekly therapist support, providing education and management strategies for cycles of persistent pain; SmilingMind is a self-guided app providing education and strategies for mindfulness practice and meditation; myWhiplash Navigator is a self-directed online program to guide people on how best to recover from a whiplash injury.
Patients rate symptoms on a daily basis at baseline and during intervention, using a mobile phone app called StudyU, over a period of 8-10 weeks. StudyU is the digital enabler of the patient's single case experiment testing the effectiveness of their chosen, self-managed activity. Participants will download the StudyU app on to their mobile phone and a personalised study will be set up for them by the study manager. StudyU has been developed to assist with single case experiments in various settings and patient groups, so it has not been developed specifically for this study, although the researchers are collaborating with the developers to improve design features for patients with persistent pain. StudyU produces a clinical report at the conclusion of each experiment, which is sent to the patient and their GP, so that the two can discuss activity effectiveness and make shared decisions about ongoing care.
Patients will be encouraged to persist with their selected activity for 6-8 weeks, in order to test effectiveness. On completion of one experiment, they may choose to conduct another experiment to test the effectiveness of a different activity.
The frequency and duration of activities will vary depending on the activity chosen by the patient, and will be self-paced and self-managed. Options involving physical activity are likely to last from 10 - 50 minutes, undertaken from daily (or most days) to 2-3 times per week. Options involving mindfulness practice are likely to be of shorter duration and up to several times a day. Options involving online modules will also be self-paced, and guided by the module design. Online activities will not be accessed through the StudyU app, but patients will use the StudyU app to rate their pain and its impact during their experiment.
Patients will record their own adherence to planned activities.
Intervention code [1] 328109 0
Behaviour
Comparator / control treatment
Baseline activity, with each patient as own control, using Baseline (A)-Intervention (B)-A or A-B design. Baseline includes any usual activity, medication or other therapy which has been unchanged over the previous 4 weeks. The intervention activity is added on to baseline activity during the intervention weeks. Patients will not be randomised to A-B-A or A-B. Patients will self-select whether they wish to return to baseline or continue with the new activity at the end of the 6 -8 week trial of the new activity. No historical data is collected. All the baseline data is self-reported by the patient on the StudyU app.
Control group
Active

Outcomes
Primary outcome [1] 337555 0
Pain interference
Timepoint [1] 337555 0
Daily during trial and one final measure at 4 weeks post-trial completion.
Primary outcome [2] 337556 0
Technology usability
Timepoint [2] 337556 0
4 weeks post-trial completion
Primary outcome [3] 337557 0
Feasibility of integration of digitally-enabled single case experiments in general practice care
Timepoint [3] 337557 0
Within 3 months following completion of patient experiments
Secondary outcome [1] 432317 0
Pain severity
Timepoint [1] 432317 0
Daily during trial using StudyU, and once more 4 weeks post-trial completion
Secondary outcome [2] 432318 0
Pain self-efficacy
Timepoint [2] 432318 0
Completed once at Baseline, once end-trial and once 4 weeks post-trial-completion
Secondary outcome [3] 432319 0
Health-related quality of life (QOL)
Timepoint [3] 432319 0
Completed once at Baseline, once end-trial and once 4 weeks post-trial-completion
Secondary outcome [4] 432321 0
Mental health
Timepoint [4] 432321 0
Completed once at Baseline, once end-trial and once 4 weeks post-trial-completion

Eligibility
Key inclusion criteria
1) >/= 18 years, 2) currently experiencing clinically significant subacute or persistent pain most days per week (average pain severity in last week of at least 3-4/10), 3) on stable dose/s of regular pain medication (including medicinal cannabis) for >/= 4 weeks prior, or not currently taking pain medication, 4) no recent changes (in last 4 weeks) in any usual pain treatment program.
History of Road Traffic Crash/accident 3 or more months prior to recruitment for inclusion in sub-group experiencing persistent pain following a road traffic crash/accident.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) acute mental health disorder or suicidal, 2) unable to use digital health apps due to impairments in cognition, vision or dexterity 3) non-English speaking, 4) no access to smartphone or Internet, 5) injection of long-acting pain medication within last 4 weeks 6) surgery planned within next 3 months.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single case experimental design using each patient as their own control, comparing baseline versus intervention. The design used will be either Baseline (A), followed by Intervention (B), followed by A (A-B-A), OR an A-B design. Patients self-select whether they wish to return to baseline (A-B-A) or continue with the new activity (A-B) at the end of the 6-8 week trial of the new activity.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315975 0
Charities/Societies/Foundations
Name [1] 315975 0
RACGP Foundation - Medibank Better Health Foundation research grant
Country [1] 315975 0
Australia
Funding source category [2] 316196 0
Charities/Societies/Foundations
Name [2] 316196 0
RACGP Foundation - Motor Accident Insurance Commission research grant
Country [2] 316196 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318116 0
Commercial sector/Industry
Name [1] 318116 0
Health Hub Doctors Morayfield
Address [1] 318116 0
Country [1] 318116 0
Australia
Secondary sponsor category [2] 318119 0
Commercial sector/Industry
Name [2] 318119 0
Hassno Plattner Institut
Address [2] 318119 0
Country [2] 318119 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314796 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 314796 0
Ethics committee country [1] 314796 0
Australia
Date submitted for ethics approval [1] 314796 0
26/01/2024
Approval date [1] 314796 0
08/02/2024
Ethics approval number [1] 314796 0
Project ID: 2023/HE000039

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

Contacts
Principal investigator
Name 132762 0
A/Prof Nancy Sturman
Address 132762 0
8th Floor, Health Sciences Building, Royal Brisbane Hospital, Butterfield St, Herston, Brisbane, Queensland 4068
Country 132762 0
Australia
Phone 132762 0
+61733461122
Fax 132762 0
Email 132762 0
n.sturman1@uq.edu.au
Contact person for public queries
Name 132763 0
Nancy Sturman
Address 132763 0
8th Floor, Health Sciences Building, Royal Brisbane Hospital, Butterfield St, Herston, Brisbane, Queensland 4068
Country 132763 0
Australia
Phone 132763 0
+61733461122
Fax 132763 0
Email 132763 0
n.sturman1@uq.edu.au
Contact person for scientific queries
Name 132764 0
Nancy Sturman
Address 132764 0
8th Floor, Health Sciences Building, Royal Brisbane Hospital, Butterfield St, Herston, Brisbane, Queensland 4068
Country 132764 0
Australia
Phone 132764 0
+61733461122
Fax 132764 0
Email 132764 0
n.sturman1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified ratings entered into StudyU app will be added to an open access repository of single case experimental design trials using the StudyU app
When will data be available (start and end dates)?
From completion of individual participant trials with no end date foreseen
Available to whom?
open access to anyone who wishes to access the data
Available for what types of analyses?
aggregation of individual participant data
How or where can data be obtained?
on application to Stefan Konigorski, Hassno Plattner Institut, via Stefan.Konigorski@hpi.de


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.