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
ACTRN12621001170819
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
30/08/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
30/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Online communication partner training after brain injury: An effectiveness-implementation study of “interact-ABI-lity”
Scientific title
Online communication partner training after brain injury: A mixed-methods, prospective, Hybrid II effectiveness-implementation study of “interact-ABI-lity” in the general public
Secondary ID [1] 304523 0
National Health and Medical Research Council (NHMRC) Postgraduate Scholarship Grant [GNT1191284]
Universal Trial Number (UTN)
U1111-1266-6628
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 322390 0
Stroke 322391 0
Condition category
Condition code
Neurological 320049 320049 0 0
Other neurological disorders
Stroke 320730 320730 0 0
Haemorrhagic
Stroke 320731 320731 0 0
Ischaemic
Public Health 320732 320732 0 0
Health promotion/education
Physical Medicine / Rehabilitation 320734 320734 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
interact-ABI-lity is a web-based, self-directed massive open online course (MOOC) providing communication partner training (CPT) to communication partners of people with acquired brain injury (ABI), including family, friends, partners, paid support workers, clinicians and the general public. It is designed for this study and available for 3 years (with possible extension pending funding). It is self-paced for an estimated 2 hours total.

Module topics include:
-Understand brain injury
-Learn about brain injury
-Why your communication is important
-Talk like a teammate
-Interacting with someone who communicates without speech
-Interacting with someone who has difficulty speaking or understanding
-Interacting with someone who has difficulty with social communication

Training is provided via short videos, text and interactive activities. It can be completed from the participants' own home/workplace.

Use of interact-ABI-lity will be monitored through online analytics (quantitative data from a minimum of 430 users) as follows:
1. Number of unique users
2. Modules completed
3. Quiz scores, and answers submitted/recorded.
4. Duration of course access
5. Date/version of course accessed

User experience of interact-ABI-lity will also be monitored through exit surveys for all users and additional qualitative interviews with a minimum of 5 voluntary consenting users of interact-ABI-lity.
Intervention code [1] 320878 0
Treatment: Other
Intervention code [2] 320879 0
Rehabilitation
Intervention code [3] 320882 0
Behaviour
Comparator / control treatment
Uncontrolled/No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327924 0
For implementation of interact-ABI-lity: adherence/fidelity via online analytics of:
1. Unique users
2. Modules completed
3. Quiz scores, answers submitted/recorded.
4. Duration of course access
5. Date/version of course accessed
Timepoint [1] 327924 0
Six weeks after soft launch (i.e. at 6 weeks), six weeks after full launch (i.e. at approximately 4 months), at six-months, and at twelve months (primary timepoint).
Primary outcome [2] 327925 0
For implementation of interact-ABI-lity: user satisfaction and experience via a survey specifically designed for this study.
Timepoint [2] 327925 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Primary outcome [3] 328549 0
For implementation of interact-ABI-lity: Intervention reach will be measured via user demographic information obtained via an entry survey specifically designed for this study.
Timepoint [3] 328549 0
Pre-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [1] 397018 0
For effectiveness of interact-ABI-lity: self-ratings of confidence interacting with people with TBI, via a questionnaire developed specifically for this study
Timepoint [1] 397018 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [2] 397019 0
For effectiveness of interact-ABI-lity: the number of appropriate strategies generated by participants in each TBI case study. Two experienced speech-language pathologists will review the lists of strategies generated by participants in each case study. The speech-language pathologists will code the strategies as appropriate or inappropriate using a consensus rating procedure.
Timepoint [2] 397019 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [3] 397020 0
For effectiveness of interact-ABI-lity: knowledge of effective communication with a person with brain injury, determined via multiple choice test developed specifically for this study
Timepoint [3] 397020 0
Pre-training, immediately post-training
Secondary outcome [4] 399391 0
PRIMARY OUTCOME

For implementation of interact-ABI-lity: the following online analytics will be used to calculate online healthcare costs and equivalent face-to-face costs using a bottom-up costing approach:
1. Unique users
2. Modules completed
3. Quiz scores, answers submitted/recorded.
4. Duration of course access
Timepoint [4] 399391 0
Post-intervention i.e. at the end of the twelve-month sampling frame of analytics (primary timepoint)
Secondary outcome [5] 399394 0
PRIMARY OUTCOME

For implementation of interact-ABI-lity: user experience of implementation barriers and facilitators when completing the interventions via a survey specifically designed for this study.
Timepoint [5] 399394 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [6] 399395 0
PRIMARY OUTCOME

For implementation of interact-ABI-lity: usability of the intervention via a survey specifically designed for this study.
Timepoint [6] 399395 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [7] 400130 0
PRIMARY OUTCOME:

For implementation of interact-ABI-lity: user satisfaction and experience via individual interviews (with a minimum of 5 users) of interact-ABI-lity
Timepoint [7] 400130 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [8] 400131 0
PRIMARY OUTCOME

For implementation of interact-ABI-lity: usability of interact-ABI-lity via individual think-aloud interviews (with a minimum of 5 users)
Timepoint [8] 400131 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [9] 400132 0
PRIMARY OUTCOME

For implementation of interact-ABI-lity: user experience of implementation barriers and facilitators when completing the interventions via individual interviews (with a minimum of 5 users) of interact-ABI-lity
Timepoint [9] 400132 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.

Eligibility
Key inclusion criteria
As interact-ABI-lity will be a publicly available online course, there are no restrictions of inclusion criteria.

A minimum of 5 users of interact-ABI-lity will need to meet the following additional criteria to participate in post-training interviews:
1. Have registered for and used at least some modules of interact-ABI-lity, as verified by course records
2. Have indicated consent at course enrolment to be contacted for further research participation opportunities related to the course
3. Have provided informed written consent to participate in the interview.
4. At least 18 years of age
5. Have adequate English proficiency to participate in the study without aid of an interpreter, with functional reading skills in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As interact-ABI-lity will be a publicly available online course, there are no restrictions of exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
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
2/07/2021
Date of last participant enrolment
Anticipated
Actual
2/07/2022
Date of last data collection
Anticipated
2/10/2022
Actual
12/10/2022
Sample size
Target
1000
Accrual to date
Final
1069
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24026 0
New Zealand
State/province [1] 24026 0

Funding & Sponsors
Funding source category [1] 308888 0
Government body
Name [1] 308888 0
National Health and Medical Research Council (NHMRC)
Country [1] 308888 0
Australia
Funding source category [2] 308891 0
University
Name [2] 308891 0
University of Technology Sydney
Country [2] 308891 0
Australia
Funding source category [3] 308892 0
Government body
Name [3] 308892 0
icare NSW
Country [3] 308892 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] 310355 0
Individual
Name [1] 310355 0
Emma Power
Address [1] 310355 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country [1] 310355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308791 0
University of Technology Sydney Medical Research Ethics Committee
Ethics committee address [1] 308791 0
Ethics committee country [1] 308791 0
Australia
Date submitted for ethics approval [1] 308791 0
28/05/2021
Approval date [1] 308791 0
29/06/2021
Ethics approval number [1] 308791 0
ETH21-6111
Ethics committee name [2] 308794 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 308794 0
Ethics committee country [2] 308794 0
Australia
Date submitted for ethics approval [2] 308794 0
11/05/2021
Approval date [2] 308794 0
11/06/2021
Ethics approval number [2] 308794 0
2019/ETH13510
Ethics committee name [3] 309176 0
University of Technology Sydney Medical Research Ethics Committee
Ethics committee address [3] 309176 0
Ethics committee country [3] 309176 0
Australia
Date submitted for ethics approval [3] 309176 0
26/03/2021
Approval date [3] 309176 0
29/06/2021
Ethics approval number [3] 309176 0
ETH21-5899

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

Contacts
Principal investigator
Name 111898 0
Ms Melissa Miao
Address 111898 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 111898 0
Australia
Phone 111898 0
+61 02 95147348
Fax 111898 0
Email 111898 0
[email protected]
Contact person for public queries
Name 111899 0
Melissa Miao
Address 111899 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 111899 0
Australia
Phone 111899 0
+61 02 95147348
Fax 111899 0
Email 111899 0
[email protected]
Contact person for scientific queries
Name 111900 0
Melissa Miao
Address 111900 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 111900 0
Australia
Phone 111900 0
+61 02 95147348
Fax 111900 0
Email 111900 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
12132Ethical 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.