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Trial registered on ANZCTR


Registration number
ACTRN12615000996561
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
23/09/2015
Date last updated
16/06/2021
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: a randomised controlled trial
Scientific title
A randomised controlled trial comparing compensatory training with compensatory plus metacognitive skills training designed to improve everyday prospective memory performance, strategy use and self-awareness in a sample of adults with traumatic brain injury
Secondary ID [1] 287407 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 296112 0
Condition category
Condition code
Injuries and Accidents 296370 296370 0 0
Other injuries and accidents
Neurological 296371 296371 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves metacognitive skills training (0.5 hours) embedded in compensatory strategy training (1.5 hour sessions) each week, for 6 weeks. Compensatory strategy training involves teaching participants how to habitually use external memory aids (e.g. diaries, mobile phones, alarms) and strategies (e.g. note-taking skills, organisational skills) to prevent prospective memory problems. Metacognitive skills training is designed to facilitate the development of self-awareness of impairments, and is combined with compensatory training to ensure the uptake and use of strategies and generalisation of strategy use in everyday life. Metacognitive training techniques include self-evaluation and self-prediction, provision of education, role modelling, and experiential, verbal and video feedback.

Treatment manuals have been developed outlining the procedures for compensatory training (COMP) and compensatory plus metacognitive skills training (COMP-MST), based on pilot research. The COMP treatment manual, which was piloted in an earlier study (Shum et al., 2011) has been amended for use in this treatment program to incorporate electronic devices used as compensatory aides (i.e. mobile phones). The MST component of the COMP-MST treatment manual has been developed by the research team.

Qualified occupational therapists who are experienced with working with people with brain injury will deliver the intervention program by one-to-one consultation in an outpatient clinic setting.

Shum, D., Fleming, J., Gill, H., Gullo, M., & Strong, J. (2011). A randomised controlled trial of prospective memory rehabilitation in adults with traumatic brain injury. Journal of Rehabilitation Medicine, 43, 216-233.
Intervention code [1] 292759 0
Rehabilitation
Intervention code [2] 292877 0
Treatment: Other
Comparator / control treatment
The COMP-MST intervention will be compared to the COMP treatment and a waitlist control condition. The group receiving compensatory training only (6 x 1.5 hour sessions) will receive an additional 30 minutes of cognitive activities as an active control for the COMP-MST group. The waitlist control group who will receive their usual care only (6 weeks duration) followed by the COMP-MST program. Usual care is the rehabilitation outpatient activities that the participant would usually be participating in whilst they are completing the research intervention. The types of usual rehabilitation activities (i.e. physiotherapy treatment) and the frequency (i.e. number of hours per week) will be documented for all participants.

Qualified occupational therapists who are experienced with working with people with brain injury will deliver the intervention program in an outpatient clinic setting.
Control group
Active

Outcomes
Primary outcome [1] 296020 0
Everyday prospective memory performance: The Brief Assessment of Prospective Memory (BAPM)
Timepoint [1] 296020 0
Baseline, immediately after completion of the 6 week intervention, and at 3 and 6 months after completion of the intervention
Primary outcome [2] 296021 0
Level of psychosocial integration: the Sydney Psychosocial Reintegration Scale Version 2 (SPRS-2)
Timepoint [2] 296021 0
Baseline, immediately after completion of the 6 week intervention, and at 3 and 6 months after completion of the intervention
Secondary outcome [1] 317258 0
Prospective memory performance and strategy use: Cambridge Prospective Memory Test (CAMPROMPT) and unprompted spontaneous note taking strategy use observed during the CAMPROMPT assessment.
Timepoint [1] 317258 0
Baseline, immediately after completion of the 6 week intervention, and at 3 and 6 months after completion of the intervention
Secondary outcome [2] 317264 0
Global self-awareness: The Awareness Questionnaire
Timepoint [2] 317264 0
Baseline, immediately after completion of the 6 week intervention, and at 3 and 6 months after completion of the intervention
Secondary outcome [3] 317272 0
Self awareness of prospective memory failure: Discrepancy between participant self-ratings and significant other ratings on the Brief Assessment of Prospective Memory (BAPM)
Timepoint [3] 317272 0
Baseline, immediately after completion of the 6 week intervention, and at 3 and 6 months after completion of the intervention
Secondary outcome [4] 317273 0
Level of support needs: the Care and Needs Scale (CANS)
Timepoint [4] 317273 0
Baseline, immediately after completion of the 6 week intervention, and at 3 and 6 months after completion of the intervention

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they (a) are aged between 18 and 65 years; (b) have had a moderate or severe TBI (as determined by GCS score and/or duration of PTA); (c) are in impaired range on the CAMPROMPT on baseline assessment or if prospective memory problems are reported by the patient or their significant other on the BAPM assessment; (d) have adequate receptive and expressive English communication skills; (e) are ambulant or independently mobile in a manual or electric wheelchair; (f) at least one month since discharge from hospital; (g) has a significant other available to participate in the study; (h)no prior brain injury or hypoxic injury; (i) able to attend the hospital for the 6-week intervention program and (j) gives informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if (a) they have not emerged from post traumatic amnesia; (b) are confused or disoriented; (c) have communication difficulties limiting comprehension of written or spoken language; or (d) are assessed by their treating occupational therapist as having impairment of cognitive function at a basic level.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified by treating therapists or case managers providing rehabilitation to people with brain injury in a specialist brain injury rehabilitation unit at a large metropolitan hospital in Queensland and a Queensland Statewide brain injury outreach service. Flyers advertising the project will also be provided to private brain injury rehabilitation practices in Brisbane, Australia and interested participants will be invited to contact the project manager. The treating therapist or case manager will briefly explain the study to prospective participants and asked if they would like to be contacted by a researcher for more information. Upon consenting to be contacted, a researcher will contact the participant to explain the project and provide them with an information and consent form.

Treating therapists and case managers will refer people with moderate to severe TBI who exhibit prospective memory deficits. Suitability for the study will be confirmed during pre-intervention assessments, where a blinded assessor will administer a neuropsychological battery of assessments testing executive function and premorbid IQ, as well as tests of prospective memory function and administration of questionnaires illiciting informaton about everyday prospective memory performance. Participant's will be classified as either 'severely impaired' (<10th percentile) or 'less severely impaired' (=or< 10th percentile) in prospective memory function defined by the CAMPROMPT normative tables based on age and premorbid IQ.
Participants in both categories will be randomly allocated to one of the three groups using sequentially numbered and sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random assignment will be conducted independent of the project staff involved in the interventions and the blind assessor. Participants will be randomly allocated to groups using stratified sampling. The CAMPROMPT will be used to classify participants as being 'severely' or 'less severely' impaired in prospective memory function. Participants in both categories will be randomly allocated to one of the three groups using sequentially numbered and sealed opaque envelopes. The envelopes will contain group allocation on a written insert, based on a predetermined random computer generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To determine required sample size, a power calculation was conducted using the primary outcome variable with the most conservative effect size from our previous RCT (i.e. the change score between pre and post SPRS score). Using G-Power and setting alpha to.05, power to .80 and an effect size of 0.70, the required sample size for each group is 26 (G*Power version 3.1.7). Sample size has been inflated to 30 participants per group to allow for an estimated dropout rate of approximately 10%. Therefore, it is calculated that a sample size of 90 participants is required for the study to be adequately powered to detect significant differences between groups.

Between-group differences will be calculated, accounting for baseline scores for all three groups on all outcomes. To address the primary aim, unstructured linear mixed regression will be used to test for group differences on the primary outcomes, with group allocation as the between subject factor and time (baseline, post-intervention, follow-up) as the within-subject or repeated variable. Any demographic or neuropsychological variables that are significantly associated with the primary outcome and unevenly distributed between the groups will be included as covariates. The same approach will be used with secondary outcome variables to address the secondary aim. Missing data will be handled using intention-to-treat analysis (i.e. most recent available data will be imputed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2015
Actual
28/10/2015
Date of last participant enrolment
Anticipated
Actual
18/06/2019
Date of last data collection
Anticipated
30/12/2019
Actual
30/12/2019
Sample size
Target
90
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4301 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 291980 0
Government body
Name [1] 291980 0
NHMRC
Country [1] 291980 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jenny Fleming
Address
Centre for Functioning and Health Research
3rd Floor, Buranda Village
Corner Cornwall Street and Ipswich Road
BURANDA QLD 4102

Mail address: PO Box 6053, BURANDA QLD 4102
Country
Australia
Secondary sponsor category [1] 290645 0
None
Name [1] 290645 0
Address [1] 290645 0
Country [1] 290645 0
Other collaborator category [1] 278608 0
University
Name [1] 278608 0
The University of Queensland
Address [1] 278608 0
The University of Queensland
School of Health and Rehabilitation Sciences
Therapies Building (84A)
Services Road
St Lucia Queensland 4072
Country [1] 278608 0
Australia
Other collaborator category [2] 278609 0
University
Name [2] 278609 0
Griffith University
Address [2] 278609 0
School of Applied Psychology
Psychology Building (M24)
Griffith University
Messines Ridge Road
Mt Gravatt Qld 4122
Country [2] 278609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293472 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 293472 0
Ethics committee country [1] 293472 0
Australia
Date submitted for ethics approval [1] 293472 0
Approval date [1] 293472 0
17/04/2015
Ethics approval number [1] 293472 0
HREC/15/QPAH/090
Ethics committee name [2] 293478 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 293478 0
Ethics committee country [2] 293478 0
Australia
Date submitted for ethics approval [2] 293478 0
Approval date [2] 293478 0
29/04/2015
Ethics approval number [2] 293478 0
2015000644

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

Contacts
Principal investigator
Name 59982 0
A/Prof Jennifer Fleming
Address 59982 0
Centre for Functioning and Health Research
3rd Floor, Buranda Village
Corner Cornwall Street and Ipswich Road, BURANDA QLD 4102

Mail address: PO Box 6053, BURANDA QLD 4102
Country 59982 0
Australia
Phone 59982 0
+61 7 3008 6955
Fax 59982 0
Email 59982 0
j.fleming@uq.edu.au
Contact person for public queries
Name 59983 0
Jennifer Fleming
Address 59983 0
Centre for Functioning and Health Research
3rd Floor, Buranda Village
Corner Cornwall Street and Ipswich Road, BURANDA QLD 4102

Mail address: PO Box 6053, BURANDA QLD 4102
Country 59983 0
Australia
Phone 59983 0
+61 7 3008 6955
Fax 59983 0
Email 59983 0
j.fleming@uq.edu.au
Contact person for scientific queries
Name 59984 0
Jennifer Fleming
Address 59984 0
Centre for Functioning and Health Research
3rd Floor, Buranda Village
Cornerr Cornwall Street and Ipswich Road, BURANDA QLD 4102

Mail address: PO Box 6053, BURANDA QLD 4102
Country 59984 0
Australia
Phone 59984 0
+61 7 3008 6955
Fax 59984 0
Email 59984 0
j.fleming@uq.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
Further discussion with investigative team


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5976Study protocol    369231-(Uploaded-23-11-2018-15-43-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: Study protocol for a randomized controlled trial.2017https://dx.doi.org/10.1186/s13063-016-1758-6
EmbaseEfficacy of Prospective Memory Rehabilitation Plus Metacognitive Skills Training for Adults With Traumatic Brain Injury: A Randomized Controlled Trial.2022https://dx.doi.org/10.1177/15459683221110886
N.B. These documents automatically identified may not have been verified by the study sponsor.