Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001024538
Ethics application status
Approved
Date submitted
8/09/2015
Date registered
1/10/2015
Date last updated
3/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using telehealth for social communication skills training for people with traumatic brain injury and their carers
Scientific title
Do people with traumatic brain injury and their carers receive equal benefit from Skype-based intervention compared to in-person intervention in terms of change in communication skills?
Secondary ID [1] 287259 0
NIL
Universal Trial Number (UTN)
Trial acronym
TBIconneCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 295877 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296130 296130 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten session, manualised communication skills program (TBIconneCT) involving education and video-based feedback to identify and develop use of positive conversation skills by the person with TBI and positive support skills by the communication partner (family member, friend, carer). Participants allocated to the telehealth group will receive all training sessions via Skype video sessions. Sessions are 1.5 hour duration and conducted weekly over ten weeks. Sessions are conducted by a speech pathologist. Intervention adherence will be monitored via a log of completed sessions, and an audit of a sample of sessions to check adherence to a checklist of intervention components.
Intervention code [1] 292559 0
Rehabilitation
Intervention code [2] 292560 0
Treatment: Other
Intervention code [3] 292561 0
Behaviour
Comparator / control treatment
Participants in the control group will receive the same therapy sessions as the intervention group, but delivered in person via home visits as per standard care.
Control group
Active

Outcomes
Primary outcome [1] 295803 0
Measure of Support in Conversation: Level of skill of the partner in providing conversational support to the person with TBI, as assessed by an independent observer
Timepoint [1] 295803 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [1] 316561 0
Measure of Participation in Conversation: Level of participation in conversation by the person with TBI, as assessed by an independent observer
Timepoint [1] 316561 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [2] 316562 0
Bond and Godfrey conversation scales: Overall quality of conversation in terms of how appropriate, effortful, interesting and rewarding the interaction is judged to be by an independent observer
Timepoint [2] 316562 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [3] 316563 0
La Trobe Communication Questionnaire: A questionnaire about the frequency of communication problems reported by the person with TBI and their communication partner
Timepoint [3] 316563 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [4] 316564 0
Communication Confidence Rating Scale for Aphasia: Confidence in communication ability self-reported by the person with TBI
Timepoint [4] 316564 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [5] 316565 0
Participation Assessment with Recombined Tools (Objective): A measure of participation across a range of areas of social and community life, as reported by the person with TBI
Timepoint [5] 316565 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [6] 316566 0
Quality of Life after Brain Injury scale: A measure of health-related quality of life as reported by the person with TBI
Timepoint [6] 316566 0
Immediately post-intervention and 3 months post-intervention
Secondary outcome [7] 316567 0
Agnew Relationship Measure (Therapeutic alliance): A measure of the strength of client-therapist alliance, as reported by the person with TBI and their communication partner
Timepoint [7] 316567 0
Post-intervention

Eligibility
Key inclusion criteria
Participants with TBI must:
(1) Have a moderate-severe TBI at least 6 months previously defined as a score on the Glasgow Coma Scale (GCS) of 9-12 (moderate) 8 or less (severe) and/or a period of Post Traumatic Amnesia (PTA) of 1-24 hours (moderate) more than 24 hours (severe),
(2) Be discharged or partially discharged from hospital, and able to spend time at home on a regular basis
(3) Have significant social communication skills deficits as identified by brain injury staff (or for self-referred participants, as observed by two independent speech pathologists using Prutting’s pragmatic protocol)
(4) Have a communication partner with whom they interact regularly
(5) Have a computer with internet connection at their home
(6) Have adequate English proficiency for completing assessment tasks without the aid of an interpreter.

Communication partners must:
(1) Interact with the person with TBI on a regular basis
(2) Have adequate English proficiency for completing assessment tasks without the aid of an interpreter
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with TBI must not have:
(a) aphasia of a severity which prevents any participation in conversation
(b) severe amnesia which would prevent participants from providing informed consent, as determined by the local neuropsychologist
(c) dysarthria of a severity which would significantly affect intelligibility to an unfamiliar listener
(d) drug or alcohol addiction, or active psychosis
(e) co-occurring degenerative neurological disorder

Communication partners must not have:
(a) Sustained a brain injury
(b) Have a known psychiatric history

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)
Participants within the Sydney metropolitan area will be allocated to either the Skype or in-person intervention at a ratio of 1:3. After completing initial assessments with the participant, the researcher will open a sealed opaque envelopes to determine the intervention.

Participants outside the Sydney metropolitan area will be allocated directly to the Skype intervention. As this arm of the study is non-randomised, allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
sample size calculations indicate that a minimum of 16 participants with TBI in each condition are required for detecting a difference between the groups using an alpha level of 0.05 and a statistical power of 80% on the primary outcome measure of Measure of Support in Conversation: Reveal Competence within a casual conversation. The sample size will therefore be set at 36 (n=18 in each group) to allow for 10% attrition during the study. 36 communication partners for these participants will also be recruited.

Initial analyses will involve repeated measures mixed ANOVAs using the outcomes of the two treatment groups and the historical control group, using the primary outcome measure, secondary outcome measures and process measures. Repeated measures mixed ANOVAs comparing post-treatment and 3 month follow-up scores will provide information about the maintenance of treatment effects. Intention to treat analyses will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2015
Actual
27/01/2015
Date of last participant enrolment
Anticipated
31/12/2017
Actual
7/11/2017
Date of last data collection
Anticipated
Actual
31/07/2018
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 4211 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 4212 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [3] 4213 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [4] 6847 0
Bathurst Base Hospital - Bathurst
Recruitment hospital [5] 6848 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment postcode(s) [1] 14512 0
2795 - Bathurst
Recruitment postcode(s) [2] 14513 0
2450 - Coffs Harbour

Funding & Sponsors
Funding source category [1] 291855 0
University
Name [1] 291855 0
The University of Sydney
Country [1] 291855 0
Australia
Funding source category [2] 294755 0
Government body
Name [2] 294755 0
Lifetime Care and Support Authority of NSW
Country [2] 294755 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 290520 0
None
Name [1] 290520 0
Address [1] 290520 0
Country [1] 290520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293366 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293366 0
Ethics committee country [1] 293366 0
Australia
Date submitted for ethics approval [1] 293366 0
26/04/2012
Approval date [1] 293366 0
19/07/2012
Ethics approval number [1] 293366 0
12/06/20/4.04

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

Contacts
Principal investigator
Name 59454 0
Prof Leanne Togher
Address 59454 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 59454 0
Australia
Phone 59454 0
+61293519639
Fax 59454 0
Email 59454 0
[email protected]
Contact person for public queries
Name 59455 0
Rachael Rietdijk
Address 59455 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 59455 0
Australia
Phone 59455 0
+61402159516
Fax 59455 0
Email 59455 0
[email protected]
Contact person for scientific queries
Name 59456 0
Rachael Rietdijk
Address 59456 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 59456 0
Australia
Phone 59456 0
+61402159516
Fax 59456 0
Email 59456 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
EmbaseA Clinical Trial Investigating Telehealth and In-Person Social Communication Skills Training for People with Traumatic Brain Injury: Participant-Reported Communication Outcomes.2020https://dx.doi.org/10.1097/HTR.0000000000000554
N.B. These documents automatically identified may not have been verified by the study sponsor.