Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001356156
Ethics application status
Approved
Date submitted
15/09/2019
Date registered
3/10/2019
Date last updated
16/11/2023
Date data sharing statement initially provided
3/10/2019
Date results provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Go Kids: Evaluation of a school-based therapy prescription app
Scientific title
Feasibility of mobile health technology for school therapy prescription, on adherence and engagement, amongst children with cerebral palsy and other neurodevelopmental disabilties
Secondary ID [1] 299230 0
Nil known
Universal Trial Number (UTN)
U1111-1239-9217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 314355 0
Neurodevelopmental disability 314356 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312690 312690 0 0
Physiotherapy
Neurological 313026 313026 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 4-week school program of prescribed therapy activities using the app we have developed for this purpose. The app is gamified and employs recognised behaviour change techniques based on Self-Determination Theory. It is also interdisciplinary, being designed for physiotherapists, occupational therapists, and speech pathologists. This program will be prescribed by the child’s usual treating therapist, who will set up the child’s program activities based on previous assessment and clinical knowledge of the child, as per normal practice. These activities may be selected from the library of therapy activity videos in the app or recorded in the customised video recording feature of the app and built into a school therapy program. The library of activity videos includes: exercises (e.g. plank on knees, bicycle legs, clam shells), stretches (e.g. piriformis stretch, triceps stretch, passive adductor stretch), balance activities (e.g. seated reaching on fit ball, single leg balance- flamingo), gross motor (e.g. frog jumps, skipping), fine motor (e.g. opening containers, lacing board), sensory-perception (e.g. sensory rice treasure hunt, spot the difference), expressive language (e.g. conjunctions- board game, word meanings- tower game), and receptive language (object cards- sorting categories, instructions- barrier game). The activities selected for the school therapy program is individualised to the child’s needs, including the selection of therapy activities to practice, and the dosage/parameters. The decision about frequency of therapy activity practice will be made jointly by the therapist and the teacher, considering classroom schedules, routines, and environmental and equipment needs.

The therapist will deliver the school program to the child using the new app, providing the child and education staff (e.g. teacher or education assistant) with instructions on how to access and use the app. The child’s parent will receive an email with a website link to download the prototype app with an access code to log in and access their program. The child will access the program by logging into the app and going through the prescribed activities. The app employs an exercise timer for each exercise, recording exercise completion, and children can also access the app's gamified features to review progress and receive rewards.
Intervention code [1] 315526 0
Rehabilitation
Intervention code [2] 315527 0
Lifestyle
Intervention code [3] 315528 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321354 0
Adherence to the therapy program: data on adherence will be collected within the app, as children move through the steps of using the app that indicate they have performed prescribed activities. Adherence will be measured and recorded as a proportion, expressed as a percentage, of the number therapy activities completed out of the total activities prescribed across the 4-week intervention period.
Timepoint [1] 321354 0
Data will be collected within the app software in real-time, and extracted at the end of each participant’s 4-week intervention.
Primary outcome [2] 321355 0
Goal attainment: measured in self-rated performance and satisfaction scores, for up to three individualised goals, for each participant, using the Canadian Occupational Performance Measure (COPM) modified for use with children. A 2 point change in score on the COPM is considered to be clinically meaningful.
Timepoint [2] 321355 0
This is a pre and post intervention comparison measure. Hence this measure will be performed before and after the 4-week intervention period.
Primary outcome [3] 321356 0
Engagement: the measurement of engagement is a developing field in mobile health technology that encompasses concepts from a number of different disciplines. There are a range or recognised methods to measure engagement and in this study, we will explore the feasibility and effectiveness of several of these methods:
1. Self-report questionnaires: such as the Digital Behaviour Change Intervention Engagement Scale and User Experience Questionaire to be completed by participating children with the support of their parents.
2. System Usage data: In addition to the adherence data, app data including frequency measures for each user in accessing different parts of the app, e.g. gamification screens, and progress tracking screens.
3. Qualitative methods: Semi-structured interviews will be completed with participating children with parents supporting, to explore engagement with the app and the school therapy program.
Timepoint [3] 321356 0
1. Self-report questionnaires will be completed at the end of the 4-week intervention period.
2. Data will be collected within the app software in real-time, and extracted at the end of each participant’s 4-week intervention.
3. Interviews will take place at the end of the 4-week intervention period.
Secondary outcome [1] 374739 0
App usability and quality: the user version of the Mobile Application Rating Scale (uMARS) will be completed by the child, with support of their parent, teacher, and therapist. In addition children will be asked to complete, with support of their parent, the System Usability Scale (SUS).
Timepoint [1] 374739 0
These surveys will be completed at the end of the 4 week intervention period.
Secondary outcome [2] 374756 0
User Interviews: Semi-structured, individual interviews will be completed with the participating children who use the app, with their parents sitting in the interviews as a support person. Interviews will encompass the child’s experience using the app and doing school therapy activities prompted by the app. Interview questions will look to provoke perceptions of usability, acceptability, and engagement. Additionally, the interviews will explore the effectiveness of gamification and behaviour change strategies. Finally, the interviews provide an opportunity to explore if and how app usage translated into real exercise.
Timepoint [2] 374756 0
One interview will be completed at the end of the 4-week intervention period.

Eligibility
Key inclusion criteria
• Age 6-12 years
• Diagnosis of Cerebral Palsy or other neurodevelopmental disability
• Effective verbal communication
• Inclusion of a school program or school recommendations in their therapy plan
• Access to an Apple iOS device with internet service (e.g. WiFi) at school
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Undergoing a medical or therapy intervention that adversely affects school attendance or prevents them from completing therapy activities

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a non-controlled feasibility study, hence a statistical calculation of sample size is not relevant. A mixed-methods design is being used, 10 participants will be recruited. This number of participants was selected to yield sufficient breadth of quantitative data and of participant qualitative records (to be gathered using semi-structured interviews) whilst ensuring the completion of the study an appropriate timeframe. Agile research designs are important when evaluating mobile health technology given the rapidly pace of change in the global technological environment.

Adherence data will be collected as the number of therapy activities completed each week of the 4-week intervention, and this can then be expressed as a proportion of the number of activities prescribed each week; this information will yield weekly adherence and can be amalgamated to total adherence for each participant. Alternatively, the data can be broken down for a detailed analysis to describe adherence for each different prescribed activity across the intervention period, and to compare adherence between different types of therapy activities (for example physiotherapy, occupational therapy, and speech pathology activities). Adherence, expressed as a percentage, is continuous data and can be described using means and standard deviations.

Self-report questionnaires, selected for measuring engagement in the technology and app quality, employ either ordinal data which can be described with median and interquartile ranges, for amalgamating overall outcomes across the participants, or for comparison between different aspects of the questionnaires.

COPM performance and satisfaction scores will be calculated for each participant, with pre-test, post-test and pre-post change scores summarised with means and standard deviations. Furthermore, the proportion of participants in each group that show a 2 point change, or greater, in COPM score will be presented; because 2 point change in score on the COPM is considered to be clinically meaningful.

The qualitative data obtained from interviews with children and their parents will be recorded and transcribed. The transcriptions will be reviewed by two researchers using guidelines for thematic analysis to abductively examine participants’ responses (combination of deductive and inductive analysis) with regard to themes of acceptability, usability, engagement, and transfer (to real exercise). The guidelines outline a process that involves: familiarisation with the data, initial code generation, theme search, theme definition and naming, and summary report. Within this process transcriptions will be reviewed and coded by each researcher using NVivo software, and the two sets of coding will be compared for reliability and consistency.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/11/2019
Actual
11/02/2020
Date of last participant enrolment
Anticipated
30/04/2020
Actual
4/03/2020
Date of last data collection
Anticipated
15/06/2020
Actual
28/06/2020
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 27994 0
6050 - Coolbinia

Funding & Sponsors
Funding source category [1] 303769 0
Government body
Name [1] 303769 0
Non-Government Centre Support, Department of Education, Government of Western Australia
Country [1] 303769 0
Australia
Primary sponsor type
Other
Name
Ability Centre Australasia
Address
PO Box 61
Mt Lawley WA 6069
Country
Australia
Secondary sponsor category [1] 303890 0
University
Name [1] 303890 0
Curtin University
Address [1] 303890 0
Kent Street
Bentley WA 6102
Country [1] 303890 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304290 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 304290 0
Ethics committee country [1] 304290 0
Australia
Date submitted for ethics approval [1] 304290 0
22/03/2019
Approval date [1] 304290 0
29/03/2019
Ethics approval number [1] 304290 0
HRE2018-0696

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

Contacts
Principal investigator
Name 96414 0
Mr Rowan Johnson
Address 96414 0
Perth Children's Hospital Locked Bag 2010 Nedlands Western Australia 6909
Country 96414 0
Australia
Phone 96414 0
+61864568515
Fax 96414 0
Email 96414 0
[email protected]
Contact person for public queries
Name 96415 0
Rowan Johnson
Address 96415 0
Perth Children's Hospital Locked Bag 2010 Nedlands Western Australia 6909
Country 96415 0
Australia
Phone 96415 0
+61864568515
Fax 96415 0
Email 96415 0
[email protected]
Contact person for scientific queries
Name 96416 0
Noula Gibson
Address 96416 0
Perth Children's Hospital Locked Bag 2010 Nedlands Western Australia 6909
Country 96416 0
Australia
Phone 96416 0
+61864564669
Fax 96416 0
Email 96416 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 of the individual participant data collected during the trial, after de-identification. The only exception will be in the case of demographic data that the research team determine has potential to cause the participant to be identifiable (e.g. a rare diagnosis); given the small size of this study within a limited age range being conducted in a single city in Australia.
When will data be available (start and end dates)?
Start: Immediately following publication, or after acceptance of PhD thesis, whichever is the latter.
End: 5 years after publication
Available to whom?
To researchers who provide a methodologically sound that describes appropriate security measures for data storage.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Mr Rowan Johnson: [email protected], +61894430211) or Supervisor (Dr Noula Gibson, [email protected], +61894430211).


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.