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Trial registered on ANZCTR
Registration number
ACTRN12625000105448
Ethics application status
Approved
Date submitted
7/11/2024
Date registered
30/01/2025
Date last updated
16/02/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
M-MAT Tele: Maximising Aphasia Treatment and Recovery across Australia through Innovative Group Telerehabilitation
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Scientific title
M-MAT Tele: Maximising Aphasia Treatment and Recovery across Australia through Innovative Group Telerehabilitation in people 3 - 12 months post stroke
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Secondary ID [1]
313052
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M-MAT Tele
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Universal Trial Number (UTN)
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Trial acronym
M-MAT Tele
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Linked study record
M-MAT Tele is related to the M-MAT study ACTRN12615000618550 in that a similar intervention is used
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Health condition
Health condition(s) or problem(s) studied:
Post stroke aphasia
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Aphasia
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Condition category
Condition code
Neurological
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0
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Other neurological disorders
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Physical Medicine / Rehabilitation
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0
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Speech therapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
M-MAT Tele is a new telehealth version of M-MAT. Telerehabilitation reduces clinician and client travel and need for treatment space while addressing geographical inequity amongst people who have experience a stroke.
-The naming battery items from the COMPARE trial (ACTRN12615000618550) are used within custom made software (see doi: 10.1080/17483107.2024.2366423) which also contains sentence frames and exemplar multimodal cues (recorded gestures, drawings and spelling).
-Games Used in M-MAT Tele
All games require the participant to verbally direct the clinician for their turn using target words, phrases and sentences. Four games are used:
1. Memory - Participants find matching shapes hidden beneath naming pictures.
2. Bingo - Participants verbally claim shapes on their card (e.g., "I have a green salad").
3. Guess the Card - Participants place tokens on pictures using target sentences. Random selection determines points.
4. Snap - Participants identify cards turned over and claim matching pairs. This task focuses on rapid verbal retrieval and interaction.
Games are alternated based on group engagement, with changes recommended every hour.
Cueing Hierarchy
On failure of word retrieval, the clinician initiates a multi-modal cueing hierarchy:
1. Independent Gesture: Participants are prompted to produce a gesture of the target to support word retrieval. If this is unsuccessful, the remained of the hierarchy is completed in full.
2. Gesture: Therapist models the gesture and has the participant repeat the word verbally while gesturing.
3. Drawing: Participants create simple sketches to depict target words and repeat the word verbally.
4. Reading and Writing: Participants write and read the target aloud.
5. Sentence Repetition: Repetition of the full sentence three times to reinforce learning.
Other participants practice the multimodal cueing steps as well to maintain engagement and inclusivity.
Linguistic Levels
1. Single Words (Level 1): e.g., "Couch."
2. Carrier Phrases (Levels 2–4): e.g., "I’d like the red couch."
3. Full Sentences (Levels 5–7): e.g., "The girl is sitting lazily on the large red couch, but she should be at school."
Participants progress to higher levels upon achieving 80% accuracy without cues. Adjustments are made to ensure challenge and engagement, with modifications for non-standard sentence structures (e.g., verbs lacking direct objects).
-Paid, trained speech pathologists
-Online via Zoom and using custom made software (10.1080/17483107.2024.2366423)
-Thirty hours over five weeks. Three therapy days each week, with 2 hours of M-MAT Tele each day. Each session involves one hour of treatment followed by a 15-minute break and another hour of treatment
-Home practice/transfer tasks provided during the five weeks of intervention, plus 12 weeks of self directed maintenance activities during the follow up phase.
-Attendance logs are kept by therapists, as are detailed therapy records including start and stop times, number of utterances produced and percentage correct, linguistic levels targeted and the duration of any interruptions. Participants report back on their home practice and this is logged by therapists. Treatment fidelity is ensured through review of recordings of the first and midpoint sessions with feedback within 48 hours.
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Intervention code [1]
330000
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Treatment: Other
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Intervention code [2]
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Rehabilitation
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Comparator / control treatment
This is a waitlist- controlled study. Participants will be randomised to either receive M-MAT Tele, or to wait 5 weeks whilst having usual care, then commence M-MAT Tele. Usual care participants will undergo aphasia therapy at the type and frequency as is available to them through the rehabilitation centre they are receiving care at.
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Control group
Active
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Outcomes
Primary outcome [1]
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Retention
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Assessment method [1]
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Retention to >80% , defined as the proportion of participants completing the study, i.e. not withdrawn from the trial at 12 week follow-up. This will be quantified through examination of the trial logs, assessment completion rate and withdrawals to identify participants who have formally withdrawn or who are no longer responding to contact from the study.
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Timepoint [1]
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Immediately post intervention
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Acceptability of M-MAT Tele from the perspectives of people with aphasia >80% positive overall rating using the Patient Satisfaction Questionnaire (PSQ)
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Timepoint [2]
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Taken within the 12 weeks post intervention completion
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Secondary outcome [1]
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Mood
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Assessment method [1]
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Using the General Health Questionnaire 12 (GHQ-12)
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Timepoint [1]
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Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
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Secondary outcome [2]
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Treatment fidelity >97% adherent
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Assessment method [2]
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Review of session recordings against pre-specified checklist
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Timepoint [2]
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Taken within the 12 weeks post intervention completion
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Secondary outcome [3]
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Word Retrieval
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Assessment method [3]
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Using the COMPARE Naming Battery
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Timepoint [3]
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Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
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Secondary outcome [4]
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Cost implications
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Assessment method [4]
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Participants will document all aphasia-related therapy or care received during the waitlist period. This information will provide a baseline for comparing resource use between the two groups. The Euroqol-5D-5L will also be taken at all timepoints. Costs of M-MAT Tele and usual care will be estimated using Australian sources for unit prices inflated to a common reference year using the Total Health Price Index. Costs and Quality adjusted Life Years will be described for each arm, and differences between groups will be expressed in cost per quality adjusted life year gained. No statistical comparisons made between arms given the unpowered sample size.
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Timepoint [4]
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12 weeks post intervention commencement
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Secondary outcome [5]
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Communication related Quality of Life (QOL)
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Assessment method [5]
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Using the SAQOL-39G
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Timepoint [5]
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Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
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Secondary outcome [6]
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Functional Communication
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Assessment method [6]
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Using the Communication EffecTiveness Index (CETI)
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Timepoint [6]
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Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
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Eligibility
Key inclusion criteria
1. Diagnosis of aphasia as indicated by a Western Aphasia Battery Revised Aphasia Quotient of less than 93.8 (Kertesz et al., 2007)
2. Aged 18 years or over
3. Living in Australia
4. Stroke 3-12 months prior to commencement of intervention/usual care phase
5. Proficient in English prior to stroke
6. Willing to use videocall for telerehabilitation, using a tablet or computer
7. Able to attend/participate in all assessments and interventions
8. Internet connection at their place of residence of greater than or equal to 25mbps (NBN’s mandated minimum speed)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Non-stroke neurological diagnoses (e.g. head injury, neurosurgery, dementia)
2. Any “marked” or “severe” apraxia of speech or dysarthria as per the Apraxia of Speech Rating Scale 3.5 (Duffy et al., 2023)
3. High level of depression, as measured by SADQ-10 (Sutcliffe & Lincoln, 1998) at time of screening assessment, that would interfere with the ability to participate in the trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by severity and completed within REDCap (Research Electronic Data Capture) with an allocation table generated by a person independent of the study.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/11/2026
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Actual
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Sample size
Target
72
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment hospital [2]
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment postcode(s) [1]
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3081 - Heidelberg West
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Recruitment postcode(s) [2]
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3220 - Geelong
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Government Department of Health and Aged Care: Medical Research Future Fund
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Stroke Foundation
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Address [2]
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Country [2]
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320093
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Country [1]
320093
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/09/2024
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Approval date [1]
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15/01/2025
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Ethics approval number [1]
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HREC/111570/Austin-2024
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Summary
Brief summary
We are conducting a study testing an online, group intervention for aphasia after stroke. This online intervention is called Multi-Modality Aphasia Therapy Tele, or M-MAT Tele. M-Mat Tele is delivered to a group of three people with aphasia with the aim of improving spoken communication. We hope to learn if M-MAT Tele is feasible and enjoyable compared to usual care, and whether to conduct a large trial that tests how well it works. M-MAT Tele is a new telehealth version of M-MAT (Pierce et al., 2024). Telerehabilitation reduces clinician and client travel and need for treatment space while addressing geographical inequity amongst people who have experience a stroke. We have preliminary evidence that M-MAT may be equally effective at a low-moderate intensity (Pierce et al., 2023). This project explores M-MAT Tele at a clinically implementable low-moderate intensity for people with aphasia of less than one year. Feasibility, acceptability, and preliminary efficacy will be explored. Results of this project will provide crucial data for applications for definitive trials of M-MAT Tele in this setting.
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Trial website
https://mmat.rehab.aphasiatherapyonline.com/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr John Pierce
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Address
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Aphasia CRE, Health Sciences Building 1 La Trobe University 1 Kingsbury Drive Bundoora Vic 3086
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Country
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Australia
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Phone
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+61 03 9479 6096
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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John Pierce
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Address
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Aphasia CRE, Health Sciences Building 1 La Trobe University 1 Kingsbury Drive Bundoora Vic 3086
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Country
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Australia
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Phone
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+61 03 9479 6096
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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John Pierce
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Address
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Aphasia CRE, Health Sciences Building 1 La Trobe University 1 Kingsbury Drive Bundoora Vic 3086
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Country
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Australia
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Phone
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+61 03 9479 6096
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Anyone
Conditions for requesting access:
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-
What individual participant data might be shared?
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All deidentified individual data
What types of analyses could be done with individual participant data?
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IPD meta analysis
When can requests for individual participant data be made (start and end dates)?
From:
Following publication, no end date determined
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
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IPD can be obtained by contacting the Chief Investigator Dr John Pierce in the Ahpasia CRE at La Trobe University via
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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.
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