Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001545257
Ethics application status
Approved
Date submitted
3/09/2018
Date registered
14/09/2018
Date last updated
3/02/2020
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of telehealth (videoconferencing software) to provide rehabilitation consultation for patients with injuries following road accidents.
Scientific title
Telerehabilitation for Trauma - Investigating the feasibility of a novel telehealth intervention to provide rehabilitation services for patients following trauma.
Secondary ID [1] 295661 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TReT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road accident trauma 309006 0
Condition category
Condition code
Injuries and Accidents 307901 307901 0 0
Fractures
Injuries and Accidents 307902 307902 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 308364 308364 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a telehealth consultation with a rehabilitation physician and allied health professional 1-3 weeks following discharge. During this consultation an assessment will be conducted to identify if there are any rehabilitation needs and rehabilitation plan will be developed. The consultation will take approx. 30 minutes. Following the consultation referrals will be made to local services for rehabilitation follow up e.g. physiotherapy, occupational therapy or psychology.
Intervention code [1] 301980 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307299 0
1. Proportion of participants with rehabilitation needs identified during telehealth consultation assessed using the study specific rehabilitation assessment tool
Timepoint [1] 307299 0
1 month post-telehealth consultation
Primary outcome [2] 307300 0
2. Levels of participant acceptance and satisfaction with the telehealth intervention assessed using a study-specific questionnaire (composite outcome).
Timepoint [2] 307300 0
1 month (primary endpoint) and 3 months post-telehealth consultation
Secondary outcome [1] 351426 0
N/a
Timepoint [1] 351426 0
N/a

Eligibility
Key inclusion criteria
- >18 years of age
- Admitted to St Vincent’s Hospital Acute Trauma Service with injuries as a direct result of road trauma. (NB. ‘Road trauma’ may include motorcycle, motor vehicle collisions, pedestrian, and pedal cycle trauma).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe traumatic brain injury
- Spinal cord injury
- Inability to communicate in English
- Deafness
- No internet access (via computer, tablet or phone)
- Already having been consulted by a rehabilitation physician and/or referred for formal rehabilitation services during admission

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics including mean, range, standard deviation and will be used to describe the sample, proportion of participants with rehabilitation needs, type of follow up required and participant feedback regarding acceptance and satisfaction with consultation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2018
Actual
26/11/2018
Date of last participant enrolment
Anticipated
17/09/2019
Actual
8/07/2019
Date of last data collection
Anticipated
17/12/2019
Actual
28/09/2019
Sample size
Target
30
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11762 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23857 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 300242 0
Government body
Name [1] 300242 0
State Insurance Regulatory Authority (formerly Motor Accident's Authority of NSW)
Country [1] 300242 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Sacred Heart Rehabilitation Services
St Vincent's Hospital, 170 Darlinghurst Road
Darlinghurst, Sydney, NSW 2010
Country
Australia
Secondary sponsor category [1] 300067 0
None
Name [1] 300067 0
Address [1] 300067 0
Country [1] 300067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301065 0
St Vincent's Hospital Human Research Ethics Commitee
Ethics committee address [1] 301065 0
Ethics committee country [1] 301065 0
Australia
Date submitted for ethics approval [1] 301065 0
08/05/2017
Approval date [1] 301065 0
11/07/2017
Ethics approval number [1] 301065 0
HREC/17/SVH/140

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

Contacts
Principal investigator
Name 85758 0
A/Prof Steven Faux
Address 85758 0
Sacred Heart Rehabilitation Services
St Vincent's Hospital, 170 Darlinghurst Road
Darlinghurst, Sydney, NSW 2010
Country 85758 0
Australia
Phone 85758 0
+61 2 8382 9516
Fax 85758 0
Email 85758 0
sfaux@stvincents.com.au
Contact person for public queries
Name 85759 0
Steven Faux
Address 85759 0
Sacred Heart Rehabilitation Services
St Vincent's Hospital, 170 Darlinghurst Road
Darlinghurst, Sydney, NSW 2010
Country 85759 0
Australia
Phone 85759 0
+61 2 8382 9516
Fax 85759 0
Email 85759 0
sfaux@stvincents.com.au
Contact person for scientific queries
Name 85760 0
Steven Faux
Address 85760 0
Sacred Heart Rehabilitation Services
St Vincent's Hospital, 170 Darlinghurst Road
Darlinghurst, Sydney, NSW 2010
Country 85760 0
Australia
Phone 85760 0
61 2 8382 9516
Fax 85760 0
Email 85760 0
sfaux@stvincents.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per HREC approved study protocol


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.