Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001254482
Ethics application status
Approved
Date submitted
11/08/2016
Date registered
7/09/2016
Date last updated
7/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting people with complex trauma injuries and their families to maximise participation through community mobility.
Scientific title
Supporting people with complex trauma injuries and their families to maximise participation through community mobility.
Secondary ID [1] 289918 0
None
Universal Trial Number (UTN)
U1111-1186-3578
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury
 299889 0
Spinal cord injury 299909 0
Trauma related orthopaedic injuries 299910 0
Condition category
Condition code
Neurological 299791 299791 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 299792 299792 0 0
Occupational therapy
Injuries and Accidents 299808 299808 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CarFreeMe TI support and education group, adapted to include modules relevant to complex trauma injuries, will be delivered and evaluated in community settings in South Australia. The intervention will include up to 8 participants per group and involve 6 sessions that will be facilitated by an Occupational Therapist, Sessions will be conducted once a week and each session will be 2.5 hours in duration. Session will include content on adjusting to losses and changes; experiences of stopping driving; alternative transport; lifestyle planning; and advocacy and support.. Session content will be adapted to be relevant to the goals identified by group members and additional individual sessions will be considered if required for specific goals. Group sessions will be interactive and encourage information sharing, using peer leaders and guest speakers where appropriate. Practical outings will provide an opportunity to trial alternate transport methods, for example public transport, and this will be included within the designated weekly sessions. A record of attendance will be completed at each session.
Intervention code [1] 295602 0
Rehabilitation
Intervention code [2] 295614 0
Treatment: Other
Comparator / control treatment
Control group will receive standard information related to transport options available. This will be in the form of a one page written information sheet sent out to them.
The control group will receive the intervention also, once the group sessions are completed for the first intervention group. Once randomised, the control group will have an 8 week waiting period before receiving the intervention.
Control group
Active

Outcomes
Primary outcome [1] 299256 0
Participation in the community through use of a GPS to record location and number of outings from home. GPS units will be worn for 7 day periods at three time points during the study.
Timepoint [1] 299256 0
GPS data collection will occur at three time points during the intervention cycle. These time points will be at Week 1-2 (prior randomisation), Week 9 (following completion of intervention by intervention group) and Week 16 (following completion of intervention by wait-list control group).
Secondary outcome [1] 326658 0
Quality of life, assessed using AQOL
Timepoint [1] 326658 0
AQoL questionnaire will be completed at three time points during the intervention cycle. These time points will be at Week 1-2 (prior randomisation), Week 9 (following completion of first intervention group) and Week 16 (following completion of second intervention group).
Secondary outcome [2] 326721 0
Confidence with ability to adjust to driving cessation, assessed using Community Mobility Self-Efficacy Scale
Timepoint [2] 326721 0
The Community Mobility Self-Efficacy Scale will be completed at three time points during the study. These time points will be at Week 1-2 (prior randomisation), Week 9 (following completion of first intervention group) and Week 16 (following completion of second intervention group).
Secondary outcome [3] 326722 0
Health related quality of life, assessed using EQ-5D-5L
Timepoint [3] 326722 0
EQ-5D-5L questionnaire will be completed at three time points during the intervention cycle. These time points will be at Week 1-2 (prior randomisation), Week 9 (following completion of first intervention group) and Week 16 (following completion of second intervention group).
Secondary outcome [4] 326723 0
Modes of transport used and subjective satisfaction, assessed using CarFreeMe TI Transport Questionnaire. This is a composite secondary outcome.
Timepoint [4] 326723 0
CarFreeMe TI Transport questionnaire will be completed at three time points during the intervention cycle. These time points will be at Week 1-2 (prior randomisation), Week 9 (following completion of first intervention group) and Week 16 (following completion of second intervention group).

Eligibility
Key inclusion criteria
Trauma injury which precludes returning to driving
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Driving, living in residential care settings (or anywhere where transport would all be provided).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Wait-list controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is based on a study using GPS as an outcome for community mobility in amputees where the mean number of community participation visits over the course of a continuous week for amputees classified as having limited mobility was 7.2, and for those with basic to normal activity was 13.7. Using the group SD of 10.9, and assuming a power of 0.8 and alpha of 0.05, a sample size of 45 would be required to detect a similar difference. Assuming a 20% drop-out, we will therefore recruit 54 participants.
Data Analysis: The obtained data will be subjected to statistical analysis using SPSS software to determine the:
1. baseline differences between the groups using independent t tests.
2. Primary outcome measure is difference in community participation between groups at week 9 via a GLM ANOVA with allocation and time as factors.
3. significance between groups uses independent sample t tests for all questionnaires.
Cost-utility analysis: An intention-to-treat analysis will be conducted to establish the difference in costs between the study arms. Utility values will be generated for individual responses to the AQOL and EQ-5D-5L, instruments for the measurement and evaluation of health-related quality of life (HRQoL), by applying the Australian general population scoring algorithm. The quality-adjusted life year (QALY) score for each participant over there 16 weeks of their follow-up will be estimated using the area under the curve method. An intention-to-treat analysis will be conducted to establish the difference in costs between the study arms. The unit of outcome will be the incremental cost per QALY gained (incremental costs divided by QALYs).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6473 0
Repatriation Hospital - Daw Park

Funding & Sponsors
Funding source category [1] 294284 0
Government body
Name [1] 294284 0
Lifetime Support Authority
Country [1] 294284 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
GPO Box 2100
Adelaide South Australia 5001
Country
Australia
Secondary sponsor category [1] 293121 0
Individual
Name [1] 293121 0
Jacki Liddle
Address [1] 293121 0
The University Of Queensland
St Andrews Place Brisbane QLD 4072
Country [1] 293121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295716 0
Southern Adelaide clinical Human Research Ethics committee
Ethics committee address [1] 295716 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Ethics committee country [1] 295716 0
Australia
Date submitted for ethics approval [1] 295716 0
01/02/2016
Approval date [1] 295716 0
29/06/2016
Ethics approval number [1] 295716 0
42.16

Summary
Brief summary
The purpose of the study is to evaluate the effectiveness of a community-based education and support program (CarFreeMe) developed in Queensland in improving community participation for people following traumatic injuries,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68206 0
A/Prof Stacey George
Address 68206 0
Rehabilitation Aged and Extended Care
Flinders University
Daws Road
Daw Park
South Australia
5041
Country 68206 0
Australia
Phone 68206 0
+61 8 8275 1103
Fax 68206 0
Email 68206 0
[email protected]
Contact person for public queries
Name 68207 0
Mrs Amy Nussio
Address 68207 0
Rehabilitation Aged and Extended Care
Flinders University
Daws Road
Daw Park
South Australia
5041
Country 68207 0
Australia
Phone 68207 0
+61 431500895
Fax 68207 0
Email 68207 0
[email protected]
Contact person for scientific queries
Name 68208 0
A/Prof Stacey George
Address 68208 0
Rehabilitation Aged and Extended Care
Flinders University
Daws Road
Daw Park
South Australia
5041
Country 68208 0
Australia
Phone 68208 0
+61 8 8275 1103
Fax 68208 0
Email 68208 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of the CarFreeMe Traumatic Injuries, a Community Mobility Group Intervention, to Increase Community Participation for People With Traumatic Injuries: A Randomized Controlled Trial With Crossover.2022https://dx.doi.org/10.3389/fneur.2022.821195
EmbaseCommunity Participation for People with Trauma Injuries: A Study Protocol of a Crossover Randomised Controlled Trial of the Effectiveness of a Community Mobility Group Intervention (CarFreeMe TI).2019https://dx.doi.org/10.1017/BrImp.2019.1
N.B. These documents automatically identified may not have been verified by the study sponsor.