Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000378224
Ethics application status
Approved
Date submitted
21/04/2009
Date registered
28/05/2009
Date last updated
24/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving self-awareness in people with brain injury using video-feedback: A double-blinded randomised controlled trial
Scientific title
Improving self-awareness in people with brain injury using video-feedback: A double-blinded randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 4638 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237047 237047 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Verbal and video-tape feedback after the client completes a functional task. The participant and the therapist will watch the video of their functional task completion, and rate the client's performance using a standard rating form.

This group will complete four intervention sessions of an hour's length, held within 4-6 weeks. The functional task is a hot meal preparation, with the participant's choice of spaghetti bolognaise or pizza.
Intervention code [1] 4398 0
Rehabilitation
Comparator / control treatment
Group 2: Verbal feedback after the client completes a functional task. The participant and the therapist will review the participant's functional completion of the task, and use a standard form to rate the participant's performance.

Group 3: Experiential feedback (standard treatment) after the client completes a functional task.

Both groups will complete four intervention sessions of an hour's length, held within 4-6 weeks. The functional task is a hot meal preparation, with the participant's choice of spaghetti bolognaise or pizza.
Control group
Active

Outcomes
Primary outcome [1] 5788 0
Online awareness will be operationalised as the number of errors made by the participant during a standardised functional task. Following the guidelines of Ownsworth et al. (submitted) errors during task performance will be classified as self-corrected errors or therapist-corrected errors. The number participant "checks" (i.e. asking the therapist for directions or confirmation) will also be recorded. An Error Self Regulation Form has been developed for this purpose and will be completed blinded assessor after watching the videotape recordings of the participant's performance
Timepoint [1] 5788 0
Baseline, after each 4 intervention sessions, and follow up at 8-weeks after the very last intervention
Secondary outcome [1] 241780 0
Awareness Questionnaire (AQ)
Timepoint [1] 241780 0
Baseline, post intervention, follow up at 8-weeks after the very last intervention
Secondary outcome [2] 241781 0
Depression Anxiety and Stress Scale (DASS)
Timepoint [2] 241781 0
Baseline, post intervention, follow up at 8-weeks after the very last intervention
Secondary outcome [3] 241782 0
Self Perception in Rehabilitation Questionnaire (SPIRQ)
Timepoint [3] 241782 0
Baseline, after each 4 intervention sessions, follow up at 8-weeks after the very last intervention

Eligibility
Key inclusion criteria
-Diagnosis of a traumatic brain injury

-At least 18 years old

-Emerged from post-traumatic amnesia (PTA) to allow for informed consent and ensure participants can recall feedback

-Functional in the English language to maximise comprehension of information

-Difference in two scores between the therapist and the participant on the Awareness Questionnaire indicating impaired self-awareness.

Provides informed consent to participate in the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Severe communication disability or behavioural changes that would compromise ability to participate in an intervention

-Expected length of rehabilitation less than intervention study period (i.e. two weeks)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
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)

Funding & Sponsors
Funding source category [1] 5042 0
Hospital
Name [1] 5042 0
Royal Rehab Centre, Sydney
Country [1] 5042 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehab Centre, Sydney
Address
PO Box 6, Ryde NSW, 1680
Country
Australia
Secondary sponsor category [1] 4360 0
None
Name [1] 4360 0
Address [1] 4360 0
Country [1] 4360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239138 0
Royal Rehabilitation Centre Ethics Committe
Ethics committee address [1] 239138 0
PO Box 6, Ryde NSW, 1680
Ethics committee country [1] 239138 0
Australia
Date submitted for ethics approval [1] 239138 0
20/01/2009
Approval date [1] 239138 0
Ethics approval number [1] 239138 0
H/09/RRCS2 (09/02)

Summary
Brief summary
Main Objective:

To determine the effectiveness of video feedback in improving on-line awareness and adjustment in persons with traumatic brain injury compared to verbal feedback and experiential feedback only.

Hypothesis:

1. Treatment Group A (video & verbal feedback) & Treatment Group B (verbal feedback) will demonstrate greater improvement in on-line awareness compared to the control (experiential feedback) group.

2. Treatment Group A (video & verbal feedback) will demonstrate greater improvement in on-line awareness than Treatment Group B (verbal feedback).

3. Gains in on-line awareness will be maintained for Treatment Group A (video & verbal feedback) at four-week follow-up.

4. No hypotheses have been generated about the impact of the treatment on measures of intellectual awareness (AQ) or emotional status (DASS), as these are exploratory variables.
Trial website
n/a
Trial related presentations / publications
Australasian Society of the Study of Brain Impairment, poster presentation on May 2009.
Public notes

Contacts
Principal investigator
Name 29516 0
Address 29516 0
Country 29516 0
Phone 29516 0
Fax 29516 0
Email 29516 0
Contact person for public queries
Name 12763 0
Julia Schmidt
Address 12763 0
PO Box 6, Ryde NSW, 1680
Country 12763 0
Australia
Phone 12763 0
+61.02.9809.2032
Fax 12763 0
Email 12763 0
julia.schmidt@royalrehab.com.au
Contact person for scientific queries
Name 3691 0
Julia Schmidt
Address 3691 0
PO Box 6, Ryde NSW, 1680
Country 3691 0
Australia
Phone 3691 0
+61.02.9809.2032
Fax 3691 0
Email 3691 0
julia.schmidt@royalrehab.com.au

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
EmbaseMaintenance of treatment effects of an occupation-based intervention with video feedback for adults with TBI.2015https://dx.doi.org/10.3233/NRE-151205
N.B. These documents automatically identified may not have been verified by the study sponsor.