Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001180808
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
2/09/2021
Date last updated
3/08/2022
Date data sharing statement initially provided
2/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Online conversation skills training after brain injury: An effectiveness-implementation study of “convers-ABI-lity”
Scientific title
Online conversation skills training after brain injury: A mixed-methods, prospective, Hybrid II effectiveness-implementation study of “convers-ABI-lity” in adults with acquired brain injury (ABI) and their communication partners
Secondary ID [1] 304975 0
National Health and Medical Research Council (NHMRC) Postgraduate Scholarship Grant [GNT1191284]
Universal Trial Number (UTN)
U1111-1268-4849
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 323125 0
Stroke 323126 0
Condition category
Condition code
Neurological 320702 320702 0 0
Other neurological disorders
Stroke 320726 320726 0 0
Haemorrhagic
Stroke 320727 320727 0 0
Ischaemic
Physical Medicine / Rehabilitation 320728 320728 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
convers-ABI-lity is a web-based conversation skills training program for a communication dyad including a person who has had an acquired brain injury (ABI) and a familiar communication partner (e.g. family, friend, partner).

convers-ABI-lity has been specifically designed for this study, adapted from a previous program called TBIconneCT. The convers-ABI-lity program is only being tested in this study, and is not publicly available at this stage.

The program will include 10 x 1 hour weekly video call sessions with a speech-language pathologist (10 hours total) and 10 x 0.5 hour weekly self-guided eLearning activities (5 hours total).

Areas covered by the program include:
-how TBI affects communication
-roles in conversation
-effective speaking and listening skills
-working together well in conversations
-keeping conversations going
-asking positive questions

Training content is delivered via weekly eLearning activities, presented via short videos, text and interactive activities, then followed up that week via a video call with the speech-language pathologist.

It can be completed from the participants' own home.

Speech-language pathologists delivering convers-ABI-lity will receive training from the research team to administer the intervention. This will include initial one hour training over Zoom video conferencing software to introduce the program, independent time (estimated two hours) to try using the platform, and one hour of follow-up training over Zoom to discuss and problem-solve use.

Use of convers-ABI-lity will be monitored through online analytics as follows:
1. Number of unique users
2. Which pages are viewed and how often
3. Answers submitted/recorded
4. Bookings/cancellations and start/finish of telehealth appointments
5. Date/version accessed

User experience of convers-ABI-lity will also be monitored through exit surveys for all users and interviews with 5 administering speech-language pathologists, 10 people with brain injury and their 10 communication partners.
Intervention code [1] 321363 0
Treatment: Devices
Intervention code [2] 321364 0
Rehabilitation
Intervention code [3] 321365 0
Behaviour
Comparator / control treatment
Uncontrolled/ No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328515 0
For implementation of convers-ABI-lity: adherence/fidelity will be obtained using online analytics of:
1. Unique users
2. Bookings/cancellations and start/finish of telehealth appointments
3. Date/version accessed
Timepoint [1] 328515 0
Immediately post-intervention for individual dyads (i.e. person with brain injury and their communication partner) (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Primary outcome [2] 328516 0
For implementation of convers-ABI-lity: user satisfaction and experience of the interventions via a survey specifically designed for this study for:
1) ten people with brain injury and
2) their ten familiar communication partners (e.g. friends, family) who have completed convers-ABI-lity
3) five clinicians delivering convers-ABI-lity
Timepoint [2] 328516 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Primary outcome [3] 328548 0
For implementation of convers-ABI-lity: usability of the intervention via a survey specifically designed for this study with:
1) ten people with brain injury and
2) their ten familiar communication partners (e.g. friends, family) who have completed convers-ABI-lity
3) five clinicians delivering convers-ABI-lity
Timepoint [3] 328548 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Secondary outcome [1] 399309 0
For effectiveness of convers-ABI-lity: conversation quality as determined from conversation recordings using the Traumatic Brain Injury (TBI) Conversation Rating Scales: Adapted Measure of Participation in Conversation and Measure of Support in Conversation (Togher et al., 2010)

Togher, L., Power, E., Tate, R., McDonald, S., & Rietdijk, R. (2010). Measuring the social interactions of people with traumatic brain injury and their communication partners: The adapted Kagan scales. Aphasiology, 24, 914-927. doi:https://doi.org/10.1080/02687030903422478
Timepoint [1] 399309 0
Initial assessment, post-assessment (immediately post-completion of final session) and 3-month follow-up, as well as additional conversation practice tasks uploaded to convers-ABI-lity over the duration of the program
Secondary outcome [2] 399310 0
For effectiveness of convers-ABI-lity: Quality of life as assessed by the Quality of Life After Brain Injury scale (von Steinbuchel et al., 2010), completed online

von Steinbuchel, N., Wilson, L., Gibbons, H., Hawthorne, G., Hofer, S., Schmidt, S., . . . QOLIBRI Task Force. (2010). Quality of Life after Brain Injury (QOLIBRI): Scale development and metric properties. Journal of Neurotrauma, 27, 1167-1185. doi:https://doi.org/10.1089/neu.2009.1076
Timepoint [2] 399310 0
Initial assessment, post-assessment (immediately post-completion of final session) and 3-month follow-up
Secondary outcome [3] 399313 0
For effectiveness of convers-ABI-lity: Perception of communicative ability via the La Trobe Communication Questionnaire (self-report and other-report) (Douglas et al., 2000), completed online

Douglas, J. M., O'Flaherty, C. A., & Snow, P. C. (2000). Measuring perception of communicative ability: the development and evaluation of the La Trobe communication questionnaire. Aphasiology, 14(3), 251-268. doi:10.1080/026870300401469
Timepoint [3] 399313 0
Initial assessment, post-assessment (immediately post-completion of final session) and 3-month follow-up
Secondary outcome [4] 399390 0
For effectiveness of convers-ABI-lity: Quantitative evaluation of conversation quality via facial expression (e.g. smile, frown and engagement) measures on a scale of 0-100, generated from conversation recordings by custom iMotions software
Timepoint [4] 399390 0
For effectiveness of convers-ABI-lity: Initial assessment, post-assessment (immediately post-completion of final session) and 3-month follow-up, as well as additional conversation practice tasks uploaded to convers-ABI-lity over the duration of the program
Secondary outcome [5] 399491 0
PRIMARY OUTCOME

For implementation of convers-ABI-lity: user satisfaction and experience of the interventions via individual interviews with:
1) ten people with brain injury and
2) their ten familiar communication partners (e.g. friends, family) who have completed convers-ABI-lity
3) five clinicians delivering convers-ABI-lity
Timepoint [5] 399491 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Secondary outcome [6] 399492 0
PRIMARY OUTCOME

For implementation of convers-ABI-lity: user experience of implementation barriers and facilitators when completing the interventions, obtained via a survey specifically designed for this study, with:
1) ten people with brain injury and
2) their ten familiar communication partners (e.g. friends, family) who have completed convers-ABI-lity
3) five clinicians delivering convers-ABI-lity
Timepoint [6] 399492 0
Immediately post-intervention for individual dyads (i.e. person with brain injury and their communication partner) (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Secondary outcome [7] 399493 0
PRIMARY OUTCOME

For implementation of convers-ABI-lity: usability of the intervention via individual think-aloud interviews with:
1) ten people with brain injury and
2) their ten familiar communication partners (e.g. friends, family) who have completed convers-ABI-lity
3) five clinicians delivering convers-ABI-lity
Timepoint [7] 399493 0
Immediately post-intervention for individual dyads (i.e. person with brain injury and their communication partner) (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Secondary outcome [8] 399494 0
PRIMARY OUTCOME

For implementation of convers-ABI-lity: Intervention reach will be measured via user demographic information obtained via an entry survey specifically designed for this study.
Timepoint [8] 399494 0
Pre-intervention (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.
Secondary outcome [9] 400138 0
PRIMARY OUTCOME

Online healthcare costs and equivalent face-to-face costs using a bottom-up costing approach will be calculated using online analytics of:
1. Unique users
2. Which pages are viewed and how often
3. Bookings/cancellations and start/finish of telehealth appointments
Timepoint [9] 400138 0
At the end of the six-month sampling frame of online analytics (primary timepoint).
Secondary outcome [10] 400139 0
PRIMARY OUTCOME

For implementation of convers-ABI-lity: user experience of implementation barriers and facilitators when completing the interventions, obtained via individual interviews with:
1) ten people with brain injury and
2) their ten familiar communication partners (e.g. friends, family) who have completed convers-ABI-lity
3) five clinicians delivering convers-ABI-lity
Timepoint [10] 400139 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 6-month implementation period.

Eligibility
Key inclusion criteria
Participants with acquired brain injury (ABI) must:
1. Have a definite moderate-severe ABI at least six months previously based on the Mayo classification scheme (at least one of the following: loss of consciousness of 30 minutes or more, post-traumatic amnesia of 24 hours of more, worst Glasgow Coma Scale total score in the first 24 hours < 13, or evidence of a significant brain imaging abnormality). People with a non-traumatic brain injury (restricted specifically to the aetiologies of stroke, hypoxic injury, brain tumour, poisoning, infection) will also be eligible to participate
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 (either self-identified or identified by a usual communication partner)
4. Have insight into their social communication skills deficits
5. Be aged between 18 and 70 years
6. Have adequate English proficiency for completing assessment tasks without the aid of an interpreter
7. Functional reading skills in English
8. Have a communication partner with whom they interact regularly who is willing to participate in co-design sessions and/or the training program

Family members or friends or paid support workers participating in the study must:
1. Regularly interact with a person with ABI (i.e., at least once a week). This person with ABI should be at least six months post-injury.
2. Have known the person with ABI for at least three months
3. Have not sustained a severe ABI
4. Be aged 18 years or over

Speech-language pathologists participating in the study must:
1. Be currently employed in a clinical speech-language pathology role
2. with people with ABI forming at least 20% of the caseload
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for participants with ABI are:
1. Aphasia of a severity which prevents any participation in conversation
2. Severe amnesia which would prevent participants from providing informed consent, as evaluated using the UBACC (University of California, San Diego Brief Assessment of Capacity to Consent; D. V. Jeste et al., “A new brief instrument for assessing decisional capacity for clinical research,” Arch Gen Psychiatry, vol. 64, no. 8, pp. 966–974, Aug. 2007, doi: 10.1001/archpsyc.64.8.966).
3. Dysarthria of a severity which significantly reduces intelligibility during conversation, as evaluated by the researcher
4. Drug or alcohol addiction which would prevent participants from reliably participating in sessions
5. Active psychosis
6. Co-occurring degenerative neurological disorder, more than one episode of moderate-severe brain injury or premorbid intellectual disability.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/07/2021
Date of last participant enrolment
Anticipated
Actual
13/11/2021
Date of last data collection
Anticipated
Actual
24/07/2022
Sample size
Target
25
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309360 0
Government body
Name [1] 309360 0
National Health and Medical Research Council (NHMRC)
Country [1] 309360 0
Australia
Funding source category [2] 309361 0
University
Name [2] 309361 0
University of Technology Sydney
Country [2] 309361 0
Australia
Funding source category [3] 309397 0
Government body
Name [3] 309397 0
icare NSW
Country [3] 309397 0
Australia
Primary sponsor type
Individual
Name
Melissa Miao
Address
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country
Australia
Secondary sponsor category [1] 310331 0
Individual
Name [1] 310331 0
Emma Power
Address [1] 310331 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country [1] 310331 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309177 0
University of Technology Sydney Medical Research Ethics Committee
Ethics committee address [1] 309177 0
Ethics committee country [1] 309177 0
Australia
Date submitted for ethics approval [1] 309177 0
26/03/2021
Approval date [1] 309177 0
29/06/2021
Ethics approval number [1] 309177 0
ETH21-5899
Ethics committee name [2] 309178 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 309178 0
Ethics committee country [2] 309178 0
Australia
Date submitted for ethics approval [2] 309178 0
11/05/2021
Approval date [2] 309178 0
11/06/2021
Ethics approval number [2] 309178 0
2019/ETH13510

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

Contacts
Principal investigator
Name 113250 0
Ms Melissa Miao
Address 113250 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 113250 0
Australia
Phone 113250 0
+61 02 95147348
Fax 113250 0
Email 113250 0
[email protected]
Contact person for public queries
Name 113251 0
Melissa Miao
Address 113251 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 113251 0
Australia
Phone 113251 0
+61 02 95147348
Fax 113251 0
Email 113251 0
[email protected]
Contact person for scientific queries
Name 113252 0
Melissa Miao
Address 113252 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 113252 0
Australia
Phone 113252 0
+61 02 95147348
Fax 113252 0
Email 113252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12774Ethical approval  [email protected]



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.