Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000992606
Ethics application status
Approved
Date submitted
25/08/2023
Date registered
12/09/2023
Date last updated
12/09/2023
Date data sharing statement initially provided
12/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a Motivational RehabChat App for Brain Injury Rehabilitation
Scientific title
Mixed methods feasibility pilot trial of a Motivational Embodied Conversational Agent for Brain Injury Rehabilitation
Secondary ID [1] 310438 0
Lifetime Support Authority Research Grant: Application number R2229
Universal Trial Number (UTN)
Trial acronym
Linked study record
Hocking J, Maeder A. Motivational Embodied Conversational Agent for Brain Injury Rehabilitation. In: Maeder A, Higa C, van den Berg M, Gough C, editors. Ebook: Telehealth Innovations in Remote Healthcare Services Delivery Global TeleHealth 2020. 2772021. p. 37 - 46.

This record is a sub-study of this study.

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury 331220 0
stroke 331221 0
Condition category
Condition code
Neurological 327982 327982 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 327983 327983 0 0
Other physical medicine / rehabilitation
Stroke 327984 327984 0 0
Ischaemic
Stroke 327985 327985 0 0
Haemorrhagic
Injuries and Accidents 328104 328104 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study incorporates a chatbot app intervention – RehabChat – which is used alongside usual brain injury rehabilitation care by client-clinician dyads to support goal-setting and goal pursuit. RehabChat has been co-designed with clients with brain injury, and with clinicians providing brain injury rehabilitation. The software platform for RehabChat is the Virtual Human platform by Clevertar Pty Ltd. All data collected by RehabChat is securely stored by Clevertar. RehabChat is an adjunct tool which helps clients achieve their rehabilitation goals and complete their practice activities by providing personalised reminders and motivational cues in-between structured therapy appointments. Early results from previous work suggest that RehabChat supports client motivation and therapy engagement.

RehabChat is used on a computing device (for example an iPad or laptop) and provides a human-computer interface with which a person can converse. The User Interface includes on the left side a human-like avatar on the left side, and text bubbles for the conversation dialogues the right side. The avatar speaks each dialogue, and the client types or clicks options to enter their responses. RehabChat is used by the client-clinician dyad at weekly appointments to enter in and update key rehabilitation content for the client’s needs (including goals, practice activities, and symptom checks). The client also uses RehabChat independently in-between appointments for reminders and motivation about their rehabilitation goals and practice activities.

The content of RehabChat is delivered as an interactive conversation, with the avatar explaining points and asking questions, and the client entering answers in response. There are two RehabChat Modules – a Training Module (completed by the participant during initial 1:1 training facilitated by the researcher), and a Rehabilitation Module (completed by a client-clinician dyad alongside usual care). The Training Module conversation is about simple topics of the weather, and of travelling in one’s local area. This Module has two parts: the first part is completed with researcher providing support and cues as needed to assist learning; and the second part is completed independently by the participant, to ensure they feel confident using RehabChat. The Rehabilitation Module focuses on goal-setting, completing prescribed practice activities in-between weekly appointments, progress reviews etc. The client-clinician dyad work through the Rehabilitation Module alongside at weekly appointments, and the client uses RehabChat independently in-between appointments.

RehabChat can be used as an adjunct intervention in varied brain injury rehabilitation contexts including outpatients, home and community services, tele-rehabilitation, and inpatient care. The intended end-users for our work are adult clients with brain injury or stroke, and clinicians who provide rehabilitation care for these clients.

In the current project, participants receive 1:1 training to learn to use RehabChat. The 1:1 training session lasts approximately one hour and includes the following: an overview discussion of how RehabChat is used alongside usual care; a RehabChat User Guide is provided and explained; the participant completes the RehabChat Training module. The participant can repeat the Training Module as many times as they like until they feel confident using the RehabChat software platform.

After the participant has completed the 1:1 training, the participant then chooses if they would like to use RehabChat alongside usual rehabilitation care for any duration up to a maximum of six weeks. The intervention duration is determined by the client-clinician dyad.

This project will recruit from governance-approved settings (private and NGO settings, and public hospitals), and additional approvals will be obtained for recruitment from other public health services to expand recruitment over the data collection period. The intended sample size is 12-20 client-clinician dyads. All participants will complete an informed consent process. Individuals who do not consent to use RehabChat will not be included in this study.

The aims of this study are to appraise the feasibility, acceptability, and usability of using RehabChat alongside usual brain injury rehabilitation care. We will gather quantitative outcome measures data and qualitative interview data. Additionally, we will extract usage data from the software portal for the Rehabilitation Module with these data categories including duration of use; and which sections of RC were completed e.g. weekly reviews (at appointments), and doing practice activities (independent use between appointments). The findings of this study will inform about any needed design updates for RehabChat, and the development of a larger randomised controlled trial.
Intervention code [1] 326840 0
Treatment: Other
Intervention code [2] 326841 0
Rehabilitation
Comparator / control treatment
No control group.
This is a single arm study for appraising feasibility, acceptability, and usability of RehabChat being used alongside usual care.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335835 0
Level of engagement in rehabilitation therapy, measured using the 'Rehabilitation Therapy Engagement Scale'
Timepoint [1] 335835 0
Completed at baseline, at completion of intervention, and one-month following completion of intervention.
Primary outcome [2] 335846 0
Level of self-efficacy, measured using the General Self-Efficacy Scale (GSE)
Timepoint [2] 335846 0
Completed at baseline, at completion of intervention, and one-month following completion of intervention.
Primary outcome [3] 335847 0
Level of motivation (primarily intrinsic motivation) during brain injury rehabilitation, measured using the Motivation for Traumatic Brain Injury Rehabilitation Questionnaire.
Timepoint [3] 335847 0
Completed at baseline, at completion of intervention, and one-month following completion of intervention.
Secondary outcome [1] 425869 0
PRIMARY OUTCOME:
Level of motivation (primarily extrinsic motivation) measured using the Brain Injury Rehabilitation Trust Motivation Questionnaire-Self (completed by client).
Timepoint [1] 425869 0
Completed at baseline, at completion of intervention, and one-month following completion of intervention.
Secondary outcome [2] 425870 0
PRIMARY OUTCOME:
Level of motivation (primarily extrinsic motivation) measured using the Brain Injury Rehabilitation Trust Motivation Questionnaire-Relative (completed by clinician).
Timepoint [2] 425870 0
Completed at baseline, at completion of intervention, and one-month following completion of intervention.
Secondary outcome [3] 425871 0
Level of anxiety and depression, measured using the Hospital Anxiety and Depression Scale.
Timepoint [3] 425871 0
Completed from one-week prior to starting intervention, throughout the intervention, and to one-week following completion of intervention.
Secondary outcome [4] 425872 0
Quick screening of general wellbeing, measured using four researcher-developed questions: for Anxiety, Depression, Motivation, and Energy.
Timepoint [4] 425872 0
Completed twice weekly: from one-week prior to starting intervention, during the intervention, and to one-week following completion of intervention.
Secondary outcome [5] 425873 0
Level of attainment of rehabilitation goals - main goal and weekly sub-goals - measured using the Goal Attainment Scale-Light version (GAS-Light).
Timepoint [5] 425873 0
Completed weekly during the intervention.
Secondary outcome [6] 425874 0
How easy RehabChat is to use, measured using the System Usability Scale.
Timepoint [6] 425874 0
Completed within one-week following completion of intervention.
Secondary outcome [7] 426328 0
The usability of RehabChat, appraised during semi-structured 1:1 interviews after training and intervention.

The 1:1 interviews will be conducted with each participant after the training session (15-20 minutes) and after the intervention (30-60 minutes) to appraise key outcomes, including usability, feasibility, acceptability.

Clients and clinicians will be interviewed separately.
Timepoint [7] 426328 0
The interview after training will be conducted at the end of the 1:1 training session. The interview after the intervention will be conducted within one-week following completion of the intervention.
Secondary outcome [8] 426329 0
The feasibility of RehabChat and using it alongside usual care, appraised during semi-structured 1:1 interviews after training and intervention.

The 1:1 interviews will be conducted with each participant after the training session (15-20 minutes) and after the intervention (30-60 minutes) to appraise key outcomes, including usability, feasibility, acceptability.

Clients and clinicians will be interviewed separately.
Timepoint [8] 426329 0
The interview after training will be conducted at the end of the 1:1 training session. The interview after the intervention will be conducted within one-week following completion of the intervention.
Secondary outcome [9] 426330 0
Acceptability of RehabChat and using it alongside usual care, appraised during semi-structured 1:1 interviews after training and intervention.

The 1:1 interviews will be conducted with each participant after the training session (15-20 minutes) and after the intervention (30-60 minutes) to appraise key outcomes, including usability, feasibility, acceptability.

Clients and clinicians will be interviewed separately.
Timepoint [9] 426330 0
The interview after training will be conducted at the end of the 1:1 training session. The interview after the intervention will be conducted within one-week following completion of the intervention.

Eligibility
Key inclusion criteria
INCLUSION CRITERIA FOR CLINICIAN PARTICIPANTS
Clinician employed by clinical site, and providing rehabilitation care for clients with brain injury or stroke.

INCLUSION CRITERIA FOR CLIENT PARTICIPANTS:
Has had at least 3 appointments with clinician
Diagnosis of brain injury or stroke
Can use a computing device (e.g. tablet, or laptop)
Can provide their own consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If individual does not provide assent.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative data will be analysed using descriptive summaries and thematic analysis.
Descriptive comparison of quantitative measures in addition to repeated measures analysis of variance where appropriate.

This study aims to recruit 12-20 client-clinician dyad pairs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314645 0
Government body
Name [1] 314645 0
Lifetime Support Authority
Country [1] 314645 0
Australia
Primary sponsor type
University
Name
Flinders Univeristy
Address
Caring Futures Institute, College of Nursing and Health SciencesFlinders UniversitySturt Rd, Bedford ParkSouth Australia 5042
Country
Australia
Secondary sponsor category [1] 316609 0
None
Name [1] 316609 0
Address [1] 316609 0
Country [1] 316609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313665 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 313665 0
CALHN Research ServicesCentral Adelaide Local Health Network Inc., SA HealthLevel 3, Roma Mitchell Building136 North TerraceAdelaide, SA 5000
Ethics committee country [1] 313665 0
Australia
Date submitted for ethics approval [1] 313665 0
Approval date [1] 313665 0
25/07/2023
Ethics approval number [1] 313665 0
CALHN number: 14079

Summary
Brief summary
It is important that people with brain injury and stroke engage in rehabilitation activities outside of their clinical appointments to maximise their recovery. Issues with memory, motivation, and therapy engagement can make it difficult for clients to undertake activities between appointments.
We have developed RehabChat – a motivational chatbot app - to assist with goal setting and achieving goals. RehabChat was co-designed with clients with brain injury and brain injury rehabilitation clinicians. RehabChat is easy to use and helps clients be motivated and involved in their rehabilitation to complete their practice activities and reach their goals. It is designed to be used alongside usual care by a client with brain injury or stroke, with their therapist providing clinical oversight. The client-clinician pair use RehabChat at weekly appointments to enter key rehabilitation information about the client’s goals and practice activities. The client then uses RehabChat independently in-between appointments for motivational cues and reminders which support the client to complete their prescribed practice activities. Results from earlier testing of RehabChat suggest that RehabChat supports client motivation and therapy engagement.
This study aims to appraise how feasible and easy it is to use RehabChat alongside usual rehabilitation care. Each participant will first receive 1:1 training to use RehabChat. Client and clinician pairs will then use RehabChat for up to six weeks and provide feedback of their experiences and perceptions. The findings from this study will inform the development of a larger clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128938 0
A/Prof Belinda Lange
Address 128938 0
Caring Futures Institute, College of Nursing and Health SciencesFlinders UniversitySturt Rd, Bedford ParkSouth Australia 5042
Country 128938 0
Australia
Phone 128938 0
+61 8 8201 8285
Fax 128938 0
Email 128938 0
belinda.lange@flinders.edu.au
Contact person for public queries
Name 128939 0
Dr Judith Hocking
Address 128939 0
Caring Futures Institute, College of Nursing and Health SciencesFlinders UniversitySturt Rd, Bedford ParkSouth Australia 5042
Country 128939 0
Australia
Phone 128939 0
+61 0466 187 793
Fax 128939 0
Email 128939 0
judith.hocking@flinders.edu.au
Contact person for scientific queries
Name 128940 0
Dr Judith Hocking
Address 128940 0
Caring Futures Institute, College of Nursing and Health SciencesFlinders UniversitySturt Rd, Bedford ParkSouth Australia 5042
Country 128940 0
Australia
Phone 128940 0
+61 0466 187 793
Fax 128940 0
Email 128940 0
judith.hocking@flinders.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?

Current supporting documents:

Updated to:
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.