Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000009314
Ethics application status
Approved
Date submitted
7/12/2016
Date registered
3/01/2017
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of computer-based training and compensatory memory rehabilitation in Acquired Brain Injury
Scientific title
Comparison of computer-based training and compensatory memory rehabilitation in Acquired Brain Injury
Secondary ID [1] 290699 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 301252 0
Memory 301253 0
Cognition 301254 0
Condition category
Condition code
Neurological 301008 301008 0 0
Other neurological disorders
Stroke 301009 301009 0 0
Ischaemic
Stroke 301010 301010 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with ABI will be randomly allocated to participate in either six week of: (A) computer-based memory training, (B) compensatory memory rehabilitation (Memory Skills Group) or C) waitlist control group. Participants will complete memory tests and questionnaires at baseline, post-intervention and 6-week follow-up.

A) Computer-based memory training: Participants will complete Lumosity (computer-based memory games) at home for 30 minutes per session, five times per week for six weeks.. LumosityTM offers memory specific training designed primarily to assist in the domains of working memory, visuospatial memory, processing speed, attention, cognitive flexibility and problem solving. Participants can flexibly decide upon which days and times to train . There are 13 different memory games that form part of the training which were selected by the researchers. These games include Face Memory Workout, Familiar Faces, Follow that Frog, Memory Lane, Memory Match, Memory Match Overdrive, Memory Matrix, Moneycomb, Monster Garden, Pinball Recall, Rhyme Workout, Rotation Matrix, and Tidal Treasure. The order in which the games were presented was varied across sessions in order to maximise engagement and the order was set by the researchers. The Researchers will be in regular contact with participants throughout the 6 week training period to address any concerns or technical complications. Frequency of training will be monitored electronically by researchers.
B) Memory Skills Group: Participants will complete the 6-week, Memory Skills Group which focuses on practical training of internal and external memory strategies and education. The 2-hour sessions will be weekly for six weeks, at Epworth HealthCare Camberwell, Richmond or Brighton, and will be facilitated by an interdisciplinary team consisting of a trained clinical neuropsychologist, speech pathologist and occupational therapist. Staff will be trained to facilitate the Memory Skills Group. Sessions will be video recorded and randomly reviewed for treatment consistency across sites. Groups provide participants with education surrounding the impact of brain injury on memory and cover a number of strategies that aim to minimise the impact of these changes on daily functioning. Strategies taught include ways of remembering names, conversations and finding your way around. Some of the strategies taught include internal strategies such as repetition, association, visual imagery and attending to detail, and external strategies such as diaries, calendars, note-taking and using electronic devices.
Intervention code [1] 296583 0
Rehabilitation
Intervention code [2] 296584 0
Treatment: Other
Comparator / control treatment
Participants allocated to the waitlist control group will be placed on a waiting list for 12 weeks during the study period. At the end of the waitlist, participants will be offered a choice of the two intervention groups (Memory Skills Group or computer-based training).
Control group
Active

Outcomes
Primary outcome [1] 300427 0
Goal Attainment Scaling will be used to evaluate the extent to which participants percieve thier personalised memory goals were accomplished during the course of the intervention.
Timepoint [1] 300427 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [1] 329946 0
Total score on Royal Prince Alfred Prospective Memory Task (RPA-ProMem)
Timepoint [1] 329946 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [2] 329947 0
Total self reported memory failures on the Everyday Memory Questionnaire-Revised
Timepoint [2] 329947 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [3] 329948 0
Bilateral working memory performance as assessed by aged scaled scores on Digits backwards and Spatial span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) and Wechsler Memory Scale Fourth Edition (WMS-IV) respectivle
Timepoint [3] 329948 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [4] 329949 0
Visual memory and learning T-scores on the Brief Visuospatial Memory Test Revised (BVMT-R)
Timepoint [4] 329949 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [5] 329950 0
Other reports of patient memory failure assessed on the other version of the Comprehensive Assessment of Prospective Memory (CAPM-other)
Timepoint [5] 329950 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [6] 329951 0
Quality of life as assessed by the Assessment of Quality of Life (AQoL-8D)
Timepoint [6] 329951 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [7] 329952 0
Anxiety total scores on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [7] 329952 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention
Secondary outcome [8] 329953 0
Self reported prospective memory failures on the Comprehensive Assessment of Prospective Memory (CAPM)
Timepoint [8] 329953 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
Secondary outcome [9] 329954 0
Depression total score on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [9] 329954 0
Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.

Eligibility
Key inclusion criteria
- diagnosis of an acquired brain injury (stroke, traumatic brain injury, hypoxic brain injury or encephalitis)
- residing in the community
- Sufficient English language and cognition to ensure successful and valid completion of outcome measures and rehabilitation
- Access to a computer and the internet and computer proficiency necessary to navigate through an online platform of training
- Subjective (self or other) memory complaints
- Ability to attend weekly memory groups held at Epworth HealthCare Richmond, Camberwell or Brighton
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have a degenerative condition impacting their memory (e.g., dementia)
- Participants who are unable to provide written informed consent
- Patients who are not proficient in English
- Patients whose cognitive or physical function would preclude participation in a group and/or completion of the computerised training as judged by their treating neuropsychologist.

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)
Allocation will be concealed in opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization will be used to create the random order for allocation of participants. Block sequences will be generated through computer software and sealed by a person independent to the research project
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
Nil other features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/01/2017
Actual
15/02/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
14/04/2020
Actual
Sample size
Target
66
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7080 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [2] 7081 0
Epworth Rehabilitation Brighton - Brighton
Recruitment hospital [3] 7082 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 14808 0
3124 - Camberwell
Recruitment postcode(s) [2] 14809 0
3186 - Brighton
Recruitment postcode(s) [3] 14810 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 295127 0
Hospital
Name [1] 295127 0
Epworth HealthCare
Country [1] 295127 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
89 Bridge Road, Richmond, VIC, 3121
Country
Australia
Secondary sponsor category [1] 293946 0
University
Name [1] 293946 0
Monash University
Address [1] 293946 0
School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton 3800 VIC
Country [1] 293946 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296477 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 296477 0
Ethics committee country [1] 296477 0
Australia
Date submitted for ethics approval [1] 296477 0
20/09/2016
Approval date [1] 296477 0
14/11/2016
Ethics approval number [1] 296477 0
EH2016-125

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

Contacts
Principal investigator
Name 70994 0
Dr Felicity Lorains
Address 70994 0
Epworth Rehabilitation Camberwell
888 Toorak Road, Camberwell, VIC, 3124
Country 70994 0
Australia
Phone 70994 0
+61 3 9426 8709
Fax 70994 0
Email 70994 0
[email protected]
Contact person for public queries
Name 70995 0
Felicity Lorains
Address 70995 0
Epworth Rehabilitation Camberwell
888 Toorak Road, Camberwell, VIC, 3124
Country 70995 0
Australia
Phone 70995 0
+61 3 9426 8709
Fax 70995 0
Email 70995 0
[email protected]
Contact person for scientific queries
Name 70996 0
Jennie Ponsford
Address 70996 0
Monash-Epworth Rehabilitation Research Centre (MERRC)
Ground Floor
185-187 Hoddle Street
RICHMOND VIC 3121
Country 70996 0
Australia
Phone 70996 0
+61 3 9905 1552
Fax 70996 0
Email 70996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To be confirmed with research team at next research meeting in 2019


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.