Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001177842
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
1/09/2021
Date last updated
4/08/2022
Date data sharing statement initially provided
1/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Online social media training after brain injury: An effectiveness-implementation study of “social-ABI-lity”
Scientific title
Online social media training after brain injury: A mixed-methods, prospective, Hybrid II effectiveness-implementation study of “social-ABI-lity” in people with acquired brain injury (ABI)
Secondary ID [1] 304976 0
National Health and Medical Research Council (NHMRC) Postgraduate Scholarship Grant [GNT1191284]
Universal Trial Number (UTN)
U1111-1268-4909
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 323127 0
Stroke 323128 0
Condition category
Condition code
Neurological 320703 320703 0 0
Other neurological disorders
Stroke 320735 320735 0 0
Haemorrhagic
Stroke 320736 320736 0 0
Ischaemic
Physical Medicine / Rehabilitation 320737 320737 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
social-ABI-lity is a web-based, self-directed massive open online course (MOOC) providing training in safe and effective social media use to people who have had an acquired brain injury (ABI). 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.

Modules include:

-What is social media?
-Staying safe in social media
-How do I use social media?
-Who can I connect with in social media?

Training content is delivered online via short videos, text and interactive activities. It can be completed from the participants' own home.

Use of social-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 social-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 social-ABI-lity
Intervention code [1] 321366 0
Treatment: Other
Intervention code [2] 321367 0
Rehabilitation
Intervention code [3] 321368 0
Behaviour
Comparator / control treatment
Uncontrolled/ No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328517 0
For implementation of social-ABI-lity: Intervention reach will be measured via user demographic information obtained via an entry survey specifically designed for this study.
Timepoint [1] 328517 0
Pre-intervention (primary timepoint).
Primary outcome [2] 328518 0
For implementation of social-ABI-lity: adherence/fidelity will be calculated via online analytics of:
1. Unique users
2. Modules completed
3. Quiz scores, answers submitted/recorded.
4. Duration of course accessed
5, Date/version of course accessed
Timepoint [2] 328518 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 twelve months (primary timepoint).
Primary outcome [3] 328519 0
For implementation of social-ABI-lity: user satisfaction and experience via a survey specifically designed for this study
Timepoint [3] 328519 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [1] 399314 0
For effectiveness of social-ABI-lity: self-ratings of frequency of use of social media, via a questionnaire developed specifically for this study.
Timepoint [1] 399314 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [2] 399315 0
For effectiveness of social-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] 399315 0
Pre-training, immediately post-training.
Secondary outcome [3] 399316 0
For effectiveness of social-ABI-lity: knowledge of effective and safe social media use, determined via multiple choice test developed specifically for this study
Timepoint [3] 399316 0
Pre-training, immediately post-training,
Secondary outcome [4] 399397 0
For effectiveness of social-ABI-lity: self-ratings of confidence using social media via a questionnaire developed specifically for this study.
Timepoint [4] 399397 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [5] 399398 0
PRIMARY OUTCOME

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 [5] 399398 0
Post-intervention i.e. at the end of the 12-month sampling frame of analytics (primary timepoint)
Secondary outcome [6] 399399 0
PRIMARY OUTCOME

For implementation of social-ABI-lity: user experience of implementation barriers and facilitators when completing the interventions via a survey specifically designed for this study
Timepoint [6] 399399 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [7] 399402 0
PRIMARY OUTCOME

For implementation of social-ABI-lity: usability of the intervention via a survey specifically designed for this study
Timepoint [7] 399402 0
Immediately post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [8] 400136 0
PRIMARY OUTCOME

For implementation of social-ABI-lity: user satisfaction and experience via individual interviews (with a minimum of 5 users) of social-ABI-lity (i.e. people who have had a brain injury) and any voluntary consenting participants who may have assisted the person to complete social-ABI-lity
Timepoint [8] 400136 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [9] 400202 0
PRIMARY OUTCOME

For implementation of social-ABI-lity: usability of the intervention via individual think-aloud interviews (with a minimum of 5 users) of social-ABI-lity (i.e. people who have had a brain injury) and any voluntary consenting participants who may have assisted the person to complete social-ABI-lity
Timepoint [9] 400202 0
As soon as possible post-intervention (primary timepoint). Cumulative participant responses will be collected over the 12-month implementation period.
Secondary outcome [10] 400203 0
PRIMARY OUTCOME

For implementation of social-ABI-lity: user experience of implementation barriers and facilitators when completing the interventions via individual interviews (with a minimum of 5 users) of social-ABI-lity (i.e. people who have had a brain injury) and any voluntary consenting participants who may have assisted the person to complete social-ABI-lity
Timepoint [10] 400203 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 social-ABI-lity will be a publicly available online course, there are no restrictions of inclusion criteria. A minimum of 5 users of social-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 social-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. For users who have an acquired brain injury (ABI), capacity to consent will be determined during a video call with a qualified speech-language pathologist according to our adapted consenting process protocol which includes relevant questions adapted from University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). People with ABI without the ability to respond correctly to all five questions presented using supported communication strategies, as outlined in the attached protocol, will be excluded from the study
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 social-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
Recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
15/01/2022
Date of last participant enrolment
Anticipated
15/01/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
430
Accrual to date
90
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24027 0
New Zealand
State/province [1] 24027 0

Funding & Sponsors
Funding source category [1] 309362 0
Government body
Name [1] 309362 0
National Health and Medical Research Council (NHMRC)
Country [1] 309362 0
Australia
Funding source category [2] 309363 0
University
Name [2] 309363 0
University of Technology Sydney
Country [2] 309363 0
Australia
Funding source category [3] 309364 0
Government body
Name [3] 309364 0
icare NSW
Country [3] 309364 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] 310333 0
Individual
Name [1] 310333 0
Emma Power
Address [1] 310333 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country [1] 310333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309179 0
University of Technology Sydney Medical Research Ethics Committee
Ethics committee address [1] 309179 0
Ethics committee country [1] 309179 0
Australia
Date submitted for ethics approval [1] 309179 0
28/05/2021
Approval date [1] 309179 0
29/06/2021
Ethics approval number [1] 309179 0
ETH21-6111
Ethics committee name [2] 309180 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 309180 0
Ethics committee country [2] 309180 0
Australia
Date submitted for ethics approval [2] 309180 0
11/05/2021
Approval date [2] 309180 0
11/06/2021
Ethics approval number [2] 309180 0
2019/ETH13510
Ethics committee name [3] 309181 0
University of Technology Sydney Medical Research Ethics Committee
Ethics committee address [3] 309181 0
Ethics committee country [3] 309181 0
Australia
Date submitted for ethics approval [3] 309181 0
26/03/2021
Approval date [3] 309181 0
29/06/2021
Ethics approval number [3] 309181 0
ETH21-5899

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

Contacts
Principal investigator
Name 113254 0
Ms Melissa Miao
Address 113254 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 113254 0
Australia
Phone 113254 0
+61 02 95147348
Fax 113254 0
Email 113254 0
melissa.miao@uts.edu.au
Contact person for public queries
Name 113255 0
Melissa Miao
Address 113255 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 113255 0
Australia
Phone 113255 0
+61 02 95147348
Fax 113255 0
Email 113255 0
melissa.miao@uts.edu.au
Contact person for scientific queries
Name 113256 0
Melissa Miao
Address 113256 0
Graduate School of Health
University of Technology Sydney
PO Box 123 Broadway NSW 2007 Australia
Country 113256 0
Australia
Phone 113256 0
+61 02 95147348
Fax 113256 0
Email 113256 0
melissa.miao@uts.edu.au

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
12775Ethical approval  melissa.miao@uts.edu.au



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.