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Trial registered on ANZCTR


Registration number
ACTRN12618001066279
Ethics application status
Approved
Date submitted
24/06/2018
Date registered
26/06/2018
Date last updated
3/03/2022
Date data sharing statement initially provided
18/03/2019
Date results provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving smartphone use after brain injury
Scientific title
A comparison of systematic instruction and error-based techniques to train the use of smartphone memory apps in people with acquired brain injury: A phase II RCT
Secondary ID [1] 294842 0
None
Universal Trial Number (UTN)
U1111-1213-7866
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory deficits 307789 0
Stroke 308500 0
Traumatic brain injury 313128 0
Encephalitis 313129 0
Hypoxic brain injury 313130 0
Tumour-related brain injury 313131 0
Condition category
Condition code
Stroke 306834 306834 0 0
Haemorrhagic
Stroke 306835 306835 0 0
Ischaemic
Neurological 311604 311604 0 0
Other neurological disorders
Injuries and Accidents 311605 311605 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Systematic Instruction

Under this approach, participants will be taught to use an app (Cozi Family Organiser) using a training method that aims to prevent and minimise error commission during learning.
Procedure: All participants will have an initial session where baseline measures (smartphone ability, neuropsychological measures and self-report questionnaires) will be administered. Following this, participants will be randomly allocated to one of the groups. Training will take place in the second session. The functionalities of the app and their real-life applications will be explained at the beginning of each of four scenarios. Then the trainer will model step by step the correct performance of the task in his/her own smartphone, while the participant follows and repeats the steps in his/her own smartphone. Trainers then provide direct instructions with different levels of prompting (which include full verbal explanation + modelling, verbal explanation + pointing, confirmation of a correct query, and no environmental support), according to the participant's progress. Under this method, errors are prevented as much as possible and if they occur the participant is stopped, and immediate corrective feedback is given. Each task is repeated until 95% of the steps are completed without cuing. Only then, the next scenario will be introduced. A total of four scenarios will be presented and the skills that will be taught include: creating, modifying and sharing a shopping list, creating and modifying an event in the calendar and making use of the smartphone while on a phone call. At the end of the training session there will be a post-training test in which the participant will be asked to independently complete tasks, similar to the ones practiced before. There will also be one- and six-week follow-up sessions in which a similar test will be conducted and where other follow-up measures will be taken.


Error-based Learning

Under this approach, participants will be taught to use an app (Cozi Family Organiser) using a training method that teaches self-regulatory skills, allowing participants to stop, check and modify their actions.
Procedure: All participants will have an initial session where baseline measures (smartphone ability, neuropsychological measures and self-report questionnaires) will be administered. Following this, participants will be randomly allocated to one of the groups. Training will take place in the second session. Participants will be encouraged to provide real-life examples where the functionalities of the app would be useful. Then the participant will read the instructions for each task step-by-step, while the trainer provides a correct demonstration. Following this, the trainer allows participants to independently attempt the tasks, to commit errors and to notice and self-correct them. They will only intervene if errors are not immediately self-corrected, in which case participants are stopped and provided with non-specific or/and specific prompts (See next paragraph). Trainer will prompt participants to make self-predictions of performance, to generate strategies for potential difficulties and will encourage a high level of reflection and self-regulation following a Stop, Check and Correct approach. Each task is repeated until 95% of the steps are completed without errors. Only then, the next scenario will be introduced. A total of four scenarios will be presented and the skills that will be taught include: creating, modifying and sharing a shopping list, creating and modifying an event in the calendar and making use of the smartphone while on a phone call. At the end of the training session there will be a post-training test in which the participant will be asked to independently complete tasks, similar to the ones practiced before. There will also be one- and six-weeks follow-up sessions in which a similar test will be conducted and where other follow-up measures will be taken.

The prompts that the trainer provides in the Error-based learning condition are guided by the following:
1. If an error is self-corrected the trainer reinforces the participant by emphasising the correct action (Well spotted, you noticed that you had to click “save” before trying to enter the time of the event)
2. If there is no self-correction, trainer immediately provides a non-specific prompt (i.e. can I get you to stop for a moment and check where you are up to in the instructions? [tap sheet]).
2.1 If error is self-corrected, give specific praise (Well done, you need to save that information first before doing that next step) and continue.
2.2 If error is still not self-corrected, a specific prompt is provided (You need to click on “save” on the top right of your screen before trying to enter the time of the event, otherwise the date of the event will disappear)
3. If the person asks a question or seeks reassurance, the trainer smiles encouragingly and gets them to check the instructions (e.g. "check the steps and see what you think - does it seem right to you?") - then provide praise or correction as needed.

Materials: All participants will use their own smartphone and will be provided with written scenarios and tasks where they can apply different functionalities of the app. Step-by-step written instructions indicating how to complete each of the trained tasks will also be provided.
All three groups will be trained with the same four scenarios. The following is an example of one of the training scenarios:
.
.
You have a doctor’s appointment on the _(Date)__
This is the relevant information of that appointment:
1. The appointment is at the Medical Centre
2. You are going alone to the appointment
3. The appointment is from 10:30 to 11:00 am
4. You have follow-up appointments every Friday and this ends on the _(date)_
5. You want to set a reminder, 3 hours earlier so you can get ready
6. Every time you go, you need to remember to bring your Medicare card, so you want to make a note about this

You close the app after you have finished
.
.
.

Trainers: The training sessions will be provided by provisionally registered psychologists who are completing their doctoral programme and who will be trained on how to deliver each training technique. The post-training test and follow-up sessions will be conducted by blinded assessors who could either be provisionally registered psychologists or research assistants (bachelor’s in psychology honours students). Both trainers and blinded assessors will be constantly supervised by one of the following endorsed neuropsychologists: Dr Rene Stolwyk (Senior lecturer and research supervisor within the School of Psychological Sciences at Monash University, since 2009. He has published over 45 journal articles in the field of neuropsychological rehabilitation), Dr Dana Wong (Senior lecturer of the School of Psychology & Public Health at La Trobe University, who has extensive experience in a variety of clinical settings since 2002) or Dr Adam McKay (Senior Clinical Neuropsychologist at Epworth Healthcare and Senior lecturer and research supervisor within the School of Psychological Sciences at Monash University).

Mode of delivery: Both training techniques will be delivered face to face and individually.

Time commitment: Four sessions of approximately two hours each. First session is to take baseline measures and to verify technical requirements of the participant’s smartphone. Second session (approximately one or two weeks after the first one) is when the training is provided. The last two sessions are one- and six- weeks follow-ups.

Location: Sessions can be completed at the Monash Psychology Centre in Notting
Hill, at the La Trobe Psychology Clinic in Bundoora, or at the participant’s home.
Intervention code [1] 301151 0
Rehabilitation
Comparator / control treatment
Trial and Error

This condition will include the same materials, scenarios/tasks, trainers, mode of delivery, time commitment and location as the two interventions.

It differs, however, in the procedure during the second (training session) session, which was designed to resemble the way that people are currently taught to use technology in rehabilitation settings. The functionalities of the app and their real-life applications will be explained at the beginning of each scenario. Then the trainer will provide a demonstration of the current performance of the tasks while the participant is observing. Following this, the participant is given the opportunity to complete the tasks through exploratory learning (trial and error). If an error is committed the trainer will provide corrective feedback. No mastery is emphasised and the participant practices until he/she considers the skill has been learnt
Control group
Active

Outcomes
Primary outcome [1] 306415 0
Proficiency of performance as measured by the number of tasks (max 15) correctly executed with the app in an independent way during post-training assessments. Three different scenarios, each with 5 tasks (Similar to the scenarios used during the training session), have been specifically designed for this study. An assessor (researcher), blinded to the type of training, will provide direct supervision during the execution of the tasks and will indicate whether the participant completed the task independently, without any intervention.
Timepoint [1] 306415 0
Three time points: Immediately after training (Second session), one-week and six-weeks (Primary time point) after the training session.
Primary outcome [2] 306435 0
Efficiency of performance as measured by the time (in seconds) taken to perform 15 tasks with the app in an independent way during post-training assessments. Three different scenarios, each with 5 tasks (Similar to the scenarios used during the training session), have been specifically designed for this study.

An assessor (researcher), blinded to the type of training, will provide direct supervision during the execution of the tasks and will measure, with a stopwatch, how long it takes to the participant to complete all the tasks for each scenario.
Timepoint [2] 306435 0
Three time points: Immediately after training (Second session), one-week and six-weeks (Primary time point) after the training session.
Secondary outcome [1] 348535 0
Frequency of smartphone use in general: Time (in minutes) spent “on screen” in the previous 7 or 10 days as recorded by the smartphone system
Timepoint [1] 348535 0
At baseline (during the first session), one- and six- weeks after the training session (Third and fourth sessions)
Secondary outcome [2] 348536 0
Frequency of smartphone use as a memory aid: Indicated by self-report of frequency of use (5-point likert-type scale) in a section of the Strategies of PDA/Smartphone Use Questionnaire developed by Svoboda, Richards, Polsinelli and Guger (2010).
Timepoint [2] 348536 0
At baseline (during the first session), one- and six- weeks after the training session (Third and fourth sessions)
Secondary outcome [3] 348537 0
Memory self-efficacy: As measured by the average of the answers to the items in the 7-point likert-type Memory Controllability Inventory (Lachman, Bandura, Weaver, & Elliott, 1995).
Timepoint [3] 348537 0
At baseline (during the first session), one- and six- weeks after the training session (Third and fourth sessions)
Secondary outcome [4] 348538 0
Confidence in smartphone use: As measured by a modified section (for the purposes of this study) of the Strategies of PDA/Smartphone Use Questionnaire (Svoboda, Richards, Polsinelli and Guger, 2010). Participant self-report with a 5-point Likert-type scale their confidence in using their functions of their smartphone.
Timepoint [4] 348538 0
At baseline (during the first session), one- and six- weeks after the training session (Third and fourth sessions)
Secondary outcome [5] 371170 0
Generalisation of skills as measured by the number of tasks correctly completed in an untrained app (called 24me) with similar functionalities that the one used for training. An assessor (researcher), blinded to the type of training, will provide direct supervision during the execution of the tasks and will indicate whether the participant independently completed the tasks.
Timepoint [5] 371170 0
Two time points: one-week and six-weeks after the training session.
Secondary outcome [6] 387777 0
Number of errors committed during the tasks with the Cozi app and the untrained apps at each time point.
Actions that are considered errors include touching unnecessary areas of the screen, selecting the wrong buttons, failing to select buttons to confirm information (i.e. save, done), clicking on pop-up ads, omitting or deleting information and entering the incorrect information. Steps taken to correct errors (i.e. selecting “cancel” or “back”) or remove ads are not counted as errors, as well as minor spelling errors that do not change the meaning of information or accidentally clicking on a different area to the intended one due to dexterity issues.
Timepoint [6] 387777 0
Three time points: Immediately after training, one-week and six-weeks after the training session.
This variable has been measured since the first participant was recruited and was added as an official secondary outcome at the time that participant number 20 was recruited
Secondary outcome [7] 387778 0
Subjective memory complaint as measured by the Everyday Memory Questionnaire, a self-reported questionnaire comprised by 13 questions.
Timepoint [7] 387778 0
Two time points: At baseline and at the six-week follow up after the training session. This variable has been measured since the first participant was recruited.

Eligibility
Key inclusion criteria
1. Participant has had an acquired brain injury (e.g. stroke, traumatic brain injury, hypoxia, encephalitis, low grade tumour or in remission)
2. Participant > 18 years
3. Participant reports memory difficulties
4. Participant has a smartphone (iPhone or Android)
5. Participant is interested in learning a new app and improve usage of smartphone
6. Participant lives in Metropolitan Melbourne and is available for 4 sessions with trainer (Approx. 2 months)
7. Participant is fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant dysphasia or low proficiency in English preventing intelligible responses and understanding of instructions
2. Severe neglect, vision or hearing difficulties precluding the person from seeing and listening to stimuli
3. Severe cognitive impairment preventing the understanding and completion of tasks
4. Motor or sensory difficulties impeding the person to manipulate a smartphone
5. Other significant neurological or psychiatric diagnoses that might impact performance
6. Having no access to a smartphone, which is the device targeted by the training

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligibility and allocation of participants will be determine by two different individuals.
Once participants have been accepted, allocation will take place though central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Covariate-adaptive randomisation will be used.
The factors that will be considered to balance the groups are:
1. Overall cognitive function (As determined by neuropsychological assessment)
2. Baseline smartphone ability (As determined by the number of basic smartphone functions that the participant can independently use - Please refer to document Smartphone Ability)
3. Age
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is difficult to conduct a sufficient power analysis given the novelty of this trial. However, considering that there have been reports of large size effects of the Systematic Instruction training method over the Trial and Error approach (Powell et al., 2012), it was determined that the total sample required for three-group comparisons was 42 participants (80% power, a = 5%, effect size f = 0.5). Considering attrition rates of 15 to 20% reported in other studies (Brkic et al., 2016; Mares et al., 2014; Powell et al., 2012), this study will aim to recruit 51 participants (18 each group).

The efficacy of the training approaches, reflected in the proficiency of performance with the Cozi app, will be compared with a 3 x 3 mixed ANOVA and post-hoc tests, where the training method is the between-subjects factor and the assessment timepoint (post-training, one- and six-weeks follow up) the within-subjects factor. The same procedure will be implemented for the analysis of the number of errors. Changes in the frequency of use of smartphone (in general and as memory aid), confidence using a smartphone and memory self-efficacy as well as the effect of the training approaches will be examined with four independent 3 x 3 mixed ANOVAs. However, a multivariate ANOVA (MANOVA) will be considered if significant correlations are identified among some or all of these four dependent variables, provided other assumptions of the model are also met. Accuracy of performance in untrained apps (generalisation) will be analysed with a 3 x 2 mixed ANOVA. Statistical significance for the analyses will be set at 0.05 (two-sided) with 95% confidence intervals. Baseline, demographic or other variables with significant effects on the outcomes will be treated as covariates in all relevant analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2018
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
30/03/2020
Date of last data collection
Anticipated
Actual
25/04/2020
Sample size
Target
51
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299439 0
University
Name [1] 299439 0
Monash University
Country [1] 299439 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences
Monash University,
18 Innovation Walk, Clayton Campus,
Wellington Road,
Clayton
VIC, 3800
Australia
Country
Australia
Secondary sponsor category [1] 299245 0
None
Name [1] 299245 0
Address [1] 299245 0
Country [1] 299245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300337 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 300337 0
Ethics committee country [1] 300337 0
Australia
Date submitted for ethics approval [1] 300337 0
29/05/2018
Approval date [1] 300337 0
08/06/2018
Ethics approval number [1] 300337 0
11761

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2801 2801 0 0
/AnzctrAttachments/375071-Ethics approval.pdf (Ethics approval)
Attachments [2] 2804 2804 0 0
/AnzctrAttachments/375071-Consent for the release of information.docx (Participant information/consent)

Contacts
Principal investigator
Name 83342 0
Mr Rene Stolwyk
Address 83342 0
School of Psychological Sciences
Monash University,
18 Innovation Walk, Clayton Campus,
Wellington Road,
Clayton
VIC, 3800
Australia
Country 83342 0
Australia
Phone 83342 0
+61 3 9902 0099
Fax 83342 0
Email 83342 0
Rene.Stolwyk@monash.edu
Contact person for public queries
Name 83343 0
Diana Ramirez
Address 83343 0
Stolwyk Lab
School of Psychological Sciences
Monash University,
18 Innovation Walk, Clayton Campus,
Wellington Road,
Clayton
VIC, 3800
Australia
Country 83343 0
Australia
Phone 83343 0
+61490966264
Fax 83343 0
Email 83343 0
diana.ramirezhernandez@monash.edu
Contact person for scientific queries
Name 83344 0
Diana Ramirez
Address 83344 0
Stolwyk Lab
School of Psychological Sciences
Monash University,
18 Innovation Walk, Clayton Campus,
Wellington Road,
Clayton
VIC, 3800
Australia
Country 83344 0
Australia
Phone 83344 0
+61490966264
Fax 83344 0
Email 83344 0
diana.ramirezhernandez@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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9429Ethical approval  Diana.ramirezhernandez@monash.edu 375071-(Uploaded-14-10-2019-10-53-58)-Study-related document.pdf
9430Study protocolRamirez-Hernandez, D., Stolwyk, R., Ownsworth, T., & Wong, D. (2021). A comparison of systematic instruction, error-based learning and trial and error to train the use of smartphone memory apps after acquired brain injury: A three-armed phase II randomised controlled trial study protocol. Brain Impairment, 22(2), 217-232. doi:10.1017/BrImp.2020.10 Diana.ramirezhernandez@monash.edu
9431Informed consent form    375071-(Uploaded-14-10-2019-11-03-37)-Study-related document.pdf



Results publications and other study-related documents

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