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Trial registered on ANZCTR


Registration number
ACTRN12622000835741
Ethics application status
Approved
Date submitted
1/06/2022
Date registered
14/06/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
14/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of smart home, mobile or wearable assistive technology used by people with Acquired Brain Injury
Scientific title
Piloting the efficacy of assistive technology used for executive function support by people with Acquired Brain Injury: A single case experimental design case series
Secondary ID [1] 307267 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 326521 0
Condition category
Condition code
Neurological 323785 323785 0 0
Other neurological disorders
Injuries and Accidents 323786 323786 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-case experiments will be conducted in Victoria (N=10) and New South Wales (N=10) by a member of the research team to test the effectiveness of smart home, mobile and wearable assistive technologies used for executive function by people with Acquired Brain Injury (ABI). These single-case experiments will be planned by the research team to ensure scientific rigor, using the Risk of Bias in N-of-1 Trials Scale. The choice of design will be individualized to each participant, based on the specific client goals and the best way to evaluate the uptake of the assistive technology. The most common design will be an A1-B1-A2-B2 withdrawal design. However, alternating treatments or multiple baseline may also be employed.

Each phase will commence immediately after the preceding phase with no wash out period to minimize changes associated with natural recovery and other rehabilitation interventions administered as part of routine care. The individual intervention (Assistive Technology product) will be tailored to each individual, based on their personal goal for executive function support and participation in activities within home and community settings. Photos of the participants home environment will be taken by an occupational therapist in the research group. These will be used to help with discussions with the research team about potential considerations regarding the layout of the house for possible technology use.

An occupational therapist in the research group will discuss the shortlist of assistive technologies, and in consultation with the participant (+/- their proxy, allied health professional) one will be selected for application. Technologies could include apps, wearables, home sensors, smart lights for example.

The specified target behavior will therefore be tailored to each participant, and as such the measurement will also vary. Some anticipated examples are measurement of whether an identified activity (e.g. taking medication, brushing teeth) was completed or not and the frequency of successful / timely task completion (measured by completion of an activity log); and the effect of a prescribed Assistive Technology product (e.g. smartwatch with a schedule of timed alerts) in changing the number of verbal cues required from a support person (measured by completion of an activity log). The frequency of measurement of the target behavior will also vary depending on the target behavior being addressed for the individual participant, but they will all be measured at most daily and at least weekly. Each phase will include a minimum of five data points.

The A 'baseline' phase will measure the target behavior and will serve as the control condition. The target behavior outcome will report whether an identified activity was completed or not, and the frequency of successful / timely task completion. For some technologies, it may be possible to use system-generated log reports, and as such, the technology will be set-up/installed (but will not be activated i.e. for reminders/prompts). If system-generated log reports are not possible, the technology will not be installed; rather a paper-based target behavior form will be completed by a proxy and used to collect data throughout all four phases.

The B phase will be the ‘intervention’ phase where Assistive Technology (AT) will be installed, worn and/or activated. If required participants (+/- their proxy) will receive a single one-hour training session by an occupational therapist on how to use the technology. Any barriers to technology use will also be identified and ameliorated, if possible. For example, if the device is not effectively mounted on the participants’ wheelchair, the occupational therapist will conduct an assessment. They will then recommend/implement a solution to mount the device, prior to the start of the intervention phase. Measurement of the target behavior will be collected as per baseline phase, i.e. same duration, with a minimum of five data points.

In the A2 ‘baseline’ phase, the technology will be uninstalled or deactivated. Measurement of the target behavior will be collected as per initial baseline phase, i.e. same duration, via proxy, with a minimum of five data points.

In the B2 ‘intervention’ phase, the technology will be reinstalled, re-worn and/or re-activated. If required participants (+/- their proxy) will received another single one-hour training session by an occupational therapist on how to use the technology. Measurement of the target behavior will be collected as per baseline phase, (i.e., same duration, via proxy), with a minimum of five data points.
Intervention code [1] 323701 0
Rehabilitation
Comparator / control treatment
Within the single-case experimental design, each participant acts as their own control. Participants undergo both the intervention and control treatments with each phase collecting a minimum of five data points.

The A phases will be the control, in which data will be collected on the target behavior, constituting usual care in the environment in which the person typically completes the target behaviour (e.g., their home).
Control group
Active

Outcomes
Primary outcome [1] 331553 0
The specified target behaviors will vary widely for each participant, hence the measurement of target behaviors will vary. Some anticipated examples are measurement of whether an identified activity (e.g. taking medication, brushing teeth) was completed or not and the frequency of successful / timely task completion (measured by completion of an activity log); and the effect of the smart home, mobile or wearable assistive technology applied in changing the number of verbal cues required from a support person (also measured by completion of an activity log).
Timepoint [1] 331553 0
The frequency of measurement of target behaviors will vary depending on the target behavior and the trial design being addressed for the individual participant, but they will all be measured at most twice daily and at least weekly during each phase of the design.
Primary outcome [2] 331554 0
Measure of goal achievement using the Goal Attainment Scaling (GAS).

To track goal achievement in conjunction with target behavior measurement, a participant-driven schedule of measurable activity will be developed, drawing upon the Goal Attainment Scaling (GAS) (Turner-Stokes, 2009). The GAS is sensitive to change, as it is a criterion-referenced measure that can quantify the degree to which adherence to the intervention has been achieved. This may include whether an identified activity was completed or not, and the frequency of successful / timely task completion. An important feature of GAS is the ‘a priori’ establishment of criteria for a successful outcome prior to the intervention, so that there is a realistic expectation of what is likely to be achieved. Each goal is rated, ranging from -2 to +2, representing level of attainment. A score of 0 meaning the expected outcome was achieved, -1 to -2 meaning the expected outcome was achieved much less and +1 to +2 suggesting the goal reached an attainment level greater than expected.
Timepoint [2] 331554 0
To be taken prior to phase A1, and at the end of each intervention phase (B1-B2).
Secondary outcome [1] 410243 0
Community Integration Questionnaire-Revised (CIQ-R).
The CIQ-R (Callaway et al., 2016) is a widely used 18-item scale that measures community integration across four domains; (1) home integration (e.g., meal preparation, housework); (2) social integration (e.g., shopping, visiting friends, leisure activities); (3) productive activity (e.g., full-time vs. part-time work, school, volunteer activities) and (4) electronic social networking (ESN) enabled social integration (e.g. use of internet-enabled ESN communication tools for social integration).
Timepoint [1] 410243 0
To be taken prior to phase A1, and at the second intervention phase (B2).
Secondary outcome [2] 410244 0
EQ-5D-5L.
The EQ-5D-5L (Devlin & Brooks, 2017) will provide a profile of health-related quality of life. The participant will be asked to rate five dimensions of their health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. They will also be asked to indicate their overall health status (‘TODAY’) using the visual analogue scale (EQ-VAS), from 0 to 100 with the end points labelled ‘the worst health you can imagine’ to ‘the best health you can imagine’.
Timepoint [2] 410244 0
To be taken prior to phase A1, and at the end of the second intervention phase (B2).
Secondary outcome [3] 410245 0
Psychosocial Impact of Assistive Devices Scale (PIADS).
The PIADS (Jutai & Day, 2002) will measure the psychosocial effects of the assistive technology device has on the participant. It is a 26-item questionnaire which involves the participant rating the impact the assistive device has had on their sense of competence, adaptability and self-esteem in daily life.
Timepoint [3] 410245 0
To be taken at the end of the second intervention phase (B2).
Secondary outcome [4] 410246 0
Quebec User Evaluation of Satisfaction with Technology (QUEST).
The Quebec User Evaluation of Satisfaction with assistive Technology, version 2.0 (QUEST) (Demers et al., 2000) will measure the participants satisfaction with a technology device and its related services. It is a 12-item measure which involves the participant (or a proxy) rate the assistive technology with regard to its physical properties, ease of use and effectiveness, using a five-point Likert scale from 1 (not satisfied at all) to 5 (very satisfied). If applicable the participant will also be asked to rate delivery, maintenance and follow up services using the same five-point scale. The participant then has the opportunity to choose the three assistive technology satisfaction items that are most important to them, from a total of 12 items.
Timepoint [4] 410246 0
To be taken at the end of the second intervention phase (B2).
Secondary outcome [5] 410247 0
Disability support utilisation and cost.

With study participants consent, disability support costs will be sourced from an administration of their funding organisation to ascertain whether the assistive technology intervention impacted disability support utilisation and cost. This data will be augmented with discussions with the participant (+/- their proxy) using a Customer Economic Evaluation Questionnaire to ensure all cost data, including informal supporter costs has been accurately captured. Data will be gathered for a maximum of three months prior to the intervention and three months following the intervention. Where three months of data is not available, a shorter time frame will be utilized with the results extrapolated to three months. Where costs are not available for disability support through the funding organisation, market rates will be applied, with the cost of informal care based on the Australian minimum wage (Australian Government, 2021). All costs will be inflated to 2022/23 by applying the Consumer Price Index (ABS, 2021).
Timepoint [5] 410247 0
To be taken prior to phase A1, and at the end of the second intervention phase (B2).

Eligibility
Key inclusion criteria
Inclusion criteria comprise: (i) having sustained an ABI; (ii) being aged 18 years or over; (iii)
living alone or with others, in a community dwelling in Victoria or New South Wales (metro / rural region); (iv) experiencing executive dysfunction (as measured by the Frontal Systems Behaviour Scale) and (v) have substantial support needs for everyday living (documented by a rating of level 4 or higher on the Care and Needs Scale).

People who do not identify as either male or female (i.e. non-binary) will also be eligible to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria comprise: (i) current severe mental health problems (as documented on the HONOS-ABI, Fleminger et al, 2005) and (ii) challenging behaviors (as documented on the Overt Behavior Scale-Adult, Kelly et al., 2013).

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
Efficacy
Statistical methods / analysis
Data from the primary and secondary outcomes will be evaluated for each individual separately, using both structured visual analysis, together with statistical techniques suitable for within-subject, time-series data. Structured visual analysis will use the standard protocol of Kratochwill et al. (2013). It will focus on six features of the data making both within- and between-phase comparisons for response level, trend, variability, immediacy, consistency, and overlap. The Tau-U technique will be used to statistically quantify overlap and generate effect sizes.

A cost benefit analysis will also be conducted by a comparison of a new intervention (i.e. the assistive technology product applied in the intervention phase) against an alternative, or comparator. In this trial, the comparator is the intervention that would usually apply to the care of the patient population of interest in the absence of the new technology, often referred to as standard care (i.e. baseline phase). From this analysis, both the incremental benefits and incremental costs of the new technology intervention over those of the comparator state for each single case will be used to determine whether the additional funding of the new technology can be justified as an intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2022
Actual
20/06/2022
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
20
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 22476 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 37709 0
3000 - Melbourne
Recruitment postcode(s) [2] 37710 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 311563 0
Government body
Name [1] 311563 0
Transport Accident Commission (VIC)
Country [1] 311563 0
Australia
Funding source category [2] 311564 0
Government body
Name [2] 311564 0
Lifetime Care and Support Authority (NSW)
Country [2] 311564 0
Australia
Primary sponsor type
Government body
Name
Transport Accident Commission (VIC)
Address
60 Brougham Street,
Geelong, VIC, Australia 3220
Country
Australia
Secondary sponsor category [1] 312980 0
Government body
Name [1] 312980 0
Lifetime Care and Support Authority (NSW)
Address [1] 312980 0
Level 24, 580 George Street
Sydney, NSW, Australia 2000
Country [1] 312980 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311012 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 311012 0
Ethics committee country [1] 311012 0
Australia
Date submitted for ethics approval [1] 311012 0
Approval date [1] 311012 0
19/01/2020
Ethics approval number [1] 311012 0
2019/ETH14038
Ethics committee name [2] 311014 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 311014 0
Ethics committee country [2] 311014 0
Australia
Date submitted for ethics approval [2] 311014 0
Approval date [2] 311014 0
18/03/2021
Ethics approval number [2] 311014 0
27923

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

Contacts
Principal investigator
Name 119694 0
A/Prof Libby Callaway
Address 119694 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre,
School of Primary and Allied Health Care,
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 119694 0
Australia
Phone 119694 0
+61 421 356 359
Fax 119694 0
Email 119694 0
Libby.Callaway@monash.edu
Contact person for public queries
Name 119695 0
Libby Callaway
Address 119695 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre,
School of Primary and Allied Health Care,
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 119695 0
Australia
Phone 119695 0
+61 421 356 359
Fax 119695 0
Email 119695 0
Libby.Callaway@monash.edu
Contact person for scientific queries
Name 119696 0
Libby Callaway
Address 119696 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre,
School of Primary and Allied Health Care,
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 119696 0
Australia
Phone 119696 0
+61 421 356 359
Fax 119696 0
Email 119696 0
Libby.Callaway@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All participant data will be deidentified and only reported at group level for the purposes of confidentiality for participants.

There are no plans for sharing IPD at this stage.


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
No additional documents have been identified.