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Trial registered on ANZCTR


Registration number
ACTRN12616001056482
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
8/08/2016
Date last updated
13/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of computer versus group memory training for memory rehabilitation post-stroke
Scientific title
A Comparison of Compensatory and Restorative Approaches to Memory Rehabilitation Post-STroke
Secondary ID [1] 289588 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition 299351 0
memory loss 299402 0
Condition category
Condition code
Stroke 299336 299336 0 0
Ischaemic
Stroke 299342 299342 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated into one of three conditions; restoration, compensation or a wait list control group. Participants allocated into the restoration condition will be asked to complete six weeks of computer memory training while participants in the compensation condition will be asked to attend a face to face memory group once a week for six weeks. Further details of each respective intervention are provided below.

For the computer memory training (i.e. restoration condition), participants will be required to complete a project specific suite of memory games developed in collaboration with Lumos labs. Training is completed on a computer at home for 30 minutes, five times per week for six weeks. Participants can flexibly decide upon which days and times to train . There are 13 different memory games that form apart of the training, with each session alternating between these games. 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.

For the group memory sessions (i.e. compensation), participants will be required to attend a face to face memory skills group for 2 hours on a weekday for a six week period. The groups are held in Notting Hill, the Austin Hospital and Monash Health sites and are run by neuropsychologists who have experience in the field of brain injury. Groups provide participants with education surrounding the impact of stroke on memory and cover a number of strategies that aim to minimise the impact of these changes on daily functioning. For instance, the group covers strategies that may be helpful to remember peoples names. Compliance with group training will be monitored using a register of attendance at each session. We will attempt to match participants to the closest group where possible.

Finally all participants will be asked to complete 'pen and paper' memory tasks immediately prior to the rehabilitation, immediately following the rehabilitation and at a six week follow up.
Intervention code [1] 295192 0
Rehabilitation
Intervention code [2] 295227 0
Treatment: Other
Comparator / control treatment
If allocated to the waitlist control condition, participants will be placed on a waiting list for a 12 week period but will be given the choice about which rehabilitation they would like to complete (i.e. either the group or the computer training).
Control group
Active

Outcomes
Primary outcome [1] 298808 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] 298808 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] 325269 0
Total score on Royal Prince Alfred Prospective Memory Task (RPA-ProMem)
Timepoint [1] 325269 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] 325270 0
Total self reported memory failures on the Everyday Memory Questionnaire-Revised
Timepoint [2] 325270 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] 325271 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) respectivley
Timepoint [3] 325271 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] 325272 0
Visual memory and learning T-scores on the Brief Visuospatial Memory Test Revised (BVMT-R)
Timepoint [4] 325272 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] 325273 0
Other reports of patient memory failure assessed on the other version of the Comprehensive Assessment of Prospective Memory (CAPM-other)
Timepoint [5] 325273 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] 325274 0
Quality of life as assessed by the Assessment of Quality of Life (AQoL-8D)
Timepoint [6] 325274 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] 325275 0
Anxiety total scores on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [7] 325275 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] 325397 0
Self reported prospective memory failures on the Comprehensive Assessment of Prospective Memory (CAPM)
Timepoint [8] 325397 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] 325398 0
Depression total score on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [9] 325398 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 stroke occurring at least three months prior to the intervention start date
*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 Notting Hill, the Austin hospital or Monash Health sites
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*History of other neurological conditions such as epilepsy and traumatic brain injury
*Diagnosis of dementia or mild cognitive impairment
*Diagnosis of transient ischemic attack (TIA) rather than stroke
*History of psychiatric or medical issues impacting upon cognition

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 was 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
A 3(restorative, compensation, waitlist) x 3(baseline, post intervention, follow up) mixed model ANOVA will be conducted.

G*power calculations (version 3.1), with an expected small-medium effect size (conservative estimate based upon recent meta analytic findings), suggest that a sample size of 69 would achieve 80% power, at an alpha level of .05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6068 0
Kingston Centre - Cheltenham
Recruitment postcode(s) [1] 13516 0
3800 - Monash University
Recruitment postcode(s) [2] 13517 0
3152 - Knox City Centre
Recruitment postcode(s) [3] 13518 0
3168 - Clayton
Recruitment postcode(s) [4] 13519 0
3153 - Bayswater
Recruitment postcode(s) [5] 13520 0
3192 - Cheltenham
Recruitment postcode(s) [6] 13521 0
3199 - Frankston
Recruitment postcode(s) [7] 13522 0
3191 - Sandringham
Recruitment postcode(s) [8] 13523 0
3150 - Brandon Park
Recruitment postcode(s) [9] 13524 0
3150 - Wheelers Hill
Recruitment postcode(s) [10] 13525 0
3150 - Glen Waverley
Recruitment postcode(s) [11] 13526 0
3152 - Studfield
Recruitment postcode(s) [12] 13527 0
3154 - The Basin
Recruitment postcode(s) [13] 13528 0
3151 - Burwood East
Recruitment postcode(s) [14] 13529 0
3156 - Ferntree Gully
Recruitment postcode(s) [15] 13530 0
3158 - Upwey
Recruitment postcode(s) [16] 13531 0
3159 - Menzies Creek
Recruitment postcode(s) [17] 13532 0
3162 - Caulfield
Recruitment postcode(s) [18] 13533 0
3163 - Glen Huntly
Recruitment postcode(s) [19] 13534 0
3166 - Oakleigh
Recruitment postcode(s) [20] 13535 0
3167 - Oakleigh South
Recruitment postcode(s) [21] 13536 0
3101 - Kew
Recruitment postcode(s) [22] 13537 0
3103 - Balwyn
Recruitment postcode(s) [23] 13538 0
3105 - Bulleen
Recruitment postcode(s) [24] 13539 0
3108 - Doncaster
Recruitment postcode(s) [25] 13540 0
3109 - Tunstall Square Po
Recruitment postcode(s) [26] 13541 0
3102 - Kew East
Recruitment postcode(s) [27] 13542 0
3121 - Burnley
Recruitment postcode(s) [28] 13543 0
3121 - Richmond
Recruitment postcode(s) [29] 13544 0
3122 - Hawthorn
Recruitment postcode(s) [30] 13545 0
3124 - Camberwell
Recruitment postcode(s) [31] 13546 0
3128 - Box Hill
Recruitment postcode(s) [32] 13547 0
3126 - Canterbury
Recruitment postcode(s) [33] 13548 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 293978 0
University
Name [1] 293978 0
Monash Unviersity
Address [1] 293978 0
School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton, VIC 3800
Country [1] 293978 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton 3800 VIC
Country
Australia
Secondary sponsor category [1] 292793 0
None
Name [1] 292793 0
Nil
Address [1] 292793 0
Nil
Country [1] 292793 0
Other collaborator category [1] 279055 0
Hospital
Name [1] 279055 0
Monash Health
Address [1] 279055 0
246 Clayton Rd, Clayton VIC 3168
Country [1] 279055 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295393 0
Monash Health
Ethics committee address [1] 295393 0
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 295393 0
Australia
Date submitted for ethics approval [1] 295393 0
22/01/2015
Approval date [1] 295393 0
10/03/2015
Ethics approval number [1] 295393 0
15037A
Ethics committee name [2] 295394 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 295394 0
Monash University

Room 111, Chancellery Building E

24 Sports Walk, Clayton Campus, Wellington Rd, Clayton VIC 3800, Australia
Ethics committee country [2] 295394 0
Australia
Date submitted for ethics approval [2] 295394 0
10/03/2015
Approval date [2] 295394 0
23/03/2015
Ethics approval number [2] 295394 0
CF15/916 - 2015000408

Summary
Brief summary
Approximately half of all survivors of stroke experience memory impairment, which can significantly impact functional independence and quality of life. Two different approaches have typically been implemented in an effort to rehabilitate memory: restoration (computer based training) and compensation (group based training).
Overall, there is no clear consensus as to whether either computer-based training or compensatory approaches to memory rehabilitation are effective or efficient for stroke patients. As a result, many survivors of stroke are purchasing costly computer training programs with unknown effectiveness.

At Monash University, we are currently running a randomised controlled trial to explore the efficacy and cost efficiency of different approaches to memory rehabilitation post stroke. Eligible participants will be randomised into a waitlist control,memory group or computer training group and will receive free memory rehabilitation over a six week period.

In doing so we aim to explore the most cost-efficient and effective way in which memory can be rehabilitated post stroke, thereby addressing a clear gap in service provision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67102 0
Dr Rene Stolwyk
Address 67102 0
School of Psychological Sciences, 18 Innovation Walk, Monash Unviersity, Clayton 3800 VIC
Country 67102 0
Australia
Phone 67102 0
+61 434 194 230
Fax 67102 0
Email 67102 0
rene.stolwyk@monash.edu
Contact person for public queries
Name 67103 0
Ms Toni Withiel
Address 67103 0
School of Psychological Sciences, 18 Innovation Walk, Monash Unviersity, Clayton 3800 VIC
Country 67103 0
Australia
Phone 67103 0
+61 411 729 045
Fax 67103 0
Email 67103 0
toni.withiel@monash.edu
Contact person for scientific queries
Name 67104 0
Ms Toni Withiel
Address 67104 0
School of Psychological Sciences, 18 Innovation Walk, Monash Unviersity, Clayton 3800 VIC
Country 67104 0
Australia
Phone 67104 0
+61 411 729 045
Fax 67104 0
Email 67104 0
toni.withiel@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary