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Trial registered on ANZCTR


Registration number
ACTRN12616001155482
Ethics application status
Approved
Date submitted
14/07/2016
Date registered
25/08/2016
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Connecting Rural Children to Therapy Supports: A Trial of Telepractice for Allied Health Service Provision
Scientific title
Connecting Rural Children to Therapy Supports: A Trial of Telepractice for Allied Health Service Provision
Secondary ID [1] 289675 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lifelong disability 299475 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299454 299454 0 0
Speech therapy
Physical Medicine / Rehabilitation 299455 299455 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children with disability and their families will receive multidisciplinary assessment and therapy, connecting to an occupational therapist and/or speech pathologist via a web-cam equipped laptop or tablet in the child’s home, school, or other community setting (i.e., telepractice). The number, frequency, and duration of telepractice sessions will be negotiated with parents/legal guardians and determined according to children’s needs. Therapy services will be delivered via telepractice over a period of 12 weeks, or a shorter period as negotiated with parents/legal guardians.
The delivery of therapy supports will be tailored to children's abilities, interests, and attention levels. Materials used in therapy could include online activities and pictures, or physical books, toys, and activities from the child's own home environment. Similarly, informational materials for parents/legal guardians relating to intervention strategies, their child's disability, and technology requirements will be tailored to the unique needs and situation of each participating child and their family.
Intervention code [1] 295296 0
Rehabilitation
Intervention code [2] 295697 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298938 0
Children's attainment of therapy goals (outcome measure selected according to individual therapy goals of each child, for example Goal Attainment Scale [GAS] or Canadian Occupational Performance Measure [COPM] or other standardised assessment measure)
Timepoint [1] 298938 0
At completion of therapy episode, or after 12 weeks (whichever occurs first)
Secondary outcome [1] 325690 0
Outcome: Therapeutic alliance between children with disability and their therapist/s.
Outcome measure: Therapeutic Alliance Scale for Children- revised (TASC-r), as reported by parent/legal guardian and therapists
Timepoint [1] 325690 0
Following 3 telepractice sessions, and following the final telepractice session
Secondary outcome [2] 325691 0
Presence of technological problems encountered during telepractice sessions. Measured via therapists completion of a log for every telepractice assessment and intervention session, drawn from therapist and participant report.
Timepoint [2] 325691 0
Each telepractice assessment and therapy session
Secondary outcome [3] 325692 0
Proportion of therapist time spent in essential but unbillable therapy support tasks (e.g., administration and preparation, trialling of telepractice platforms). Measured via therapists completion of a time log throughout the study
Timepoint [3] 325692 0
Collected throughout duration of therapy episode
Secondary outcome [4] 325693 0
Additional equipment and infrastructure costs to families and therapists. Measured via therapists completion of a log of additional expenses throughout the study
Timepoint [4] 325693 0
Collected throughout duration of therapy episode
Secondary outcome [5] 325694 0
Parents/legal guardians’, stakeholders’ and therapists' experiences with, and perceptions of telepractice collected via semi-structured interviews
Timepoint [5] 325694 0
Following completion of the therapy episode (for parents/legal guardians and stakeholders), or following completion of telepractice therapy episodes with at least two participating children (for therapists).
Secondary outcome [6] 326994 0
Nature of technological issues encountered during telepractice sessions. Measured via therapists completion of a log for every telepractice assessment and intervention session, drawn from therapist and participant report.
Timepoint [6] 326994 0
Each telepractice assessment and therapy session

Eligibility
Key inclusion criteria
Inclusion criteria for children/adolescents:
a) Child or adolescent aged 0-18 years
b) Living in a rural or remote community in Australia
c) Eligibility for Individual Funded Packages under the National Disability Insurance Scheme
d) Have identified goals and support needs that may be supported by speech pathology and/or occupational therapy
e) Access to a computer or tablet with camera and microphone, and reliable internet connection, either within the family home or via alternative venues in the community (e.g., Maternal and Child Health Centres, schools, or Primary Health Networks).
f) Parental/legal guardian written informed consent and willingness to comply with the study
g) Child’s verbal assent (wherever possible) to participation in the study
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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
Type of endpoint/s
Statistical methods / analysis
Quantitative data (i.e., therapy outcome data, telepractice process data and data on business model factors) will be analysed descriptively by researchers who have not been involved in the delivery of telepractice services.
Qualitative analysis of interview data will identify key issues or themes relevant to each case. Key themes and issues will then be compared and contrasted across all cases, in order to identify commonalities and differences.
Qualitative and qualitative analyses will be integrated with a detailed description of the service delivery model utilised for each case in order to provide a more complete understanding of the results and to identify important implications for the wider implementation of telepractice for therapy service provision.
This project will involve only a small number of children and families in order to collect preliminary information on the feasibility of telepractice, including factors that promote its viability. The findings of this small preliminary study will be used to inform design of a larger Phase II trial of telepractice delivery of therapy services to answer group-based research questions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2016
Actual
13/02/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
31/10/2017
Date of last data collection
Anticipated
1/03/2018
Actual
25/09/2018
Sample size
Target
15
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294056 0
Charities/Societies/Foundations
Name [1] 294056 0
auDA Foundation Grant
Country [1] 294056 0
Australia
Primary sponsor type
University
Name
Faculty of Health Sciences, University of Sydney
Address
PO Box 170
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 292883 0
None
Name [1] 292883 0
Address [1] 292883 0
Country [1] 292883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295470 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295470 0
Ethics committee country [1] 295470 0
Australia
Date submitted for ethics approval [1] 295470 0
11/05/2016
Approval date [1] 295470 0
22/09/2016
Ethics approval number [1] 295470 0
Project no.: 2016/483

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

Contacts
Principal investigator
Name 67410 0
Dr Monique Hines
Address 67410 0
Level 2, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, 2006
Country 67410 0
Australia
Phone 67410 0
+61 2 8627 7279
Fax 67410 0
Email 67410 0
[email protected]
Contact person for public queries
Name 67411 0
Monique Hines
Address 67411 0
Level 2, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, 2006
Country 67411 0
Australia
Phone 67411 0
+61 2 8627 7279
Fax 67411 0
Email 67411 0
[email protected]
Contact person for scientific queries
Name 67412 0
Monique Hines
Address 67412 0
Level 2, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, 2006
Country 67412 0
Australia
Phone 67412 0
+61 2 8627 7279
Fax 67412 0
Email 67412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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