Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001445864
Ethics application status
Approved
Date submitted
21/05/2021
Date registered
25/10/2021
Date last updated
5/10/2022
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of combined Cognitive Rehabilitation and Psychological Intervention following stroke.
Scientific title
A randomised controlled trial of combined Cognitive Rehabilitation and Psychological Intervention for memory dysfunction following stroke.
Secondary ID [1] 304244 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 321945 0
Condition category
Condition code
Stroke 319676 319676 0 0
Haemorrhagic
Stroke 319677 319677 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The manualised Making the Most of your Memory: An everyday Memory Skills Program (Radford, et al., 2012) adapted for Telehealth delivery (Lawson, et al., 2020), will be modified to include psychological intervention for managing distress, mood and anxiety commonly exacerbated following stroke. Weekly sessions will be 2.5 hours for 6 weeks in length and follow a consistent structure each week: (i) Psychoeducation on cognitive functioning, (ii) Introduction and practice of internal and external cognitive compensatory strategies, (iii) Education on Lifestyle factors (diet, sleep and exercise on cognitive function and wellbeing), and (iv) Psychoeducation and Practice of Psychological Strategies for mood and anxiety (eg. psychoeducation on emotional changes following stroke, including stress, depression and anxiety, cognitive and behavioural interventions including cognitive challenging of unhelpful thinking, behavioural interventions for low mood, stress management strategies including relaxation and mindfulness, and Value-based action). The mode of delivery will be telehealth sessions of 8 participants. They will be conducted by Clinical Psychologists and/or Clinical Neuropsychologists via PEXIP, a NSW Health approved platform with the capability to provide secure group-based intervention with presentation capabilities to display content and for interactive participant engagement. We will monitor attendance, engagement in skills practice during Group, and completion of homework tasks.

Reference:
Radford, K., Lah, S., Thayer, Z., Say, M. J., & Miller, L. A. (2012). Improving memory in outpatients with neurological disorders using a group-based training program. Journal of the International Neuropsychological Society: JINS, 18(4), 738.

Lawson, D. W., Stolwyk, R. J., Ponsford, J. L., McKenzie, D. P., Downing, M. G., & Wong, D. (2020). Telehealth delivery of memory rehabilitation following stroke. Journal of the International Neuropsychological Society, 26(1), 58-71.
Intervention code [1] 320581 0
Rehabilitation
Intervention code [2] 320582 0
Other interventions
Intervention code [3] 321590 0
Behaviour
Comparator / control treatment
Waitlist control.
Participants who are randomly selected to be part of the waitlist control group will still complete the same assessments of mood and cognition, (Initial, 7-8 weeks, and Further 3 month’s follow-up) as those participants who complete the Telehealth Group. After completion of the waitlist period (which is after the further 3 month follow-up testing session), waitlist participants will then be invited to complete the Telehealth Group. The purpose of the waitlist control group is to allow an accurate evaluation of whether the Telehealth Group is of benefit, over and above the improvements people may notice with time since their stroke. After completion of the waitlist period, waitlist participants will then be invited to complete the Telehealth Group.
Control group
Active

Outcomes
Primary outcome [1] 327562 0
Rey Auditory Verbal Learning Test (RAVLT) long delay recall
Timepoint [1] 327562 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [1] 395669 0
Rivermead Behavioural Memory test - version II)
Timepoint [1] 395669 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [2] 395670 0
Comprehensive Assessment of Prospective Memory
Timepoint [2] 395670 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [3] 395671 0
Oxford Cognitive Screen
Timepoint [3] 395671 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [4] 395672 0
auditory working memory assessed by WAIS-IV Digit Span Subtest
Timepoint [4] 395672 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [5] 395673 0
verbal impulse control assessed by Hayling’s sentence completion test,
Timepoint [5] 395673 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [6] 395674 0
visual impulse control assessed by Trail Making Test.
Timepoint [6] 395674 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [7] 400389 0
Everyday Memory Questionnaire (EMQ)
Timepoint [7] 400389 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [8] 400390 0
visual working memory assessed by WMS Symbol Span subtest
Timepoint [8] 400390 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.
Secondary outcome [9] 400391 0
abstract reasoning WAIS-IV Matrix Reasoning subtest
Timepoint [9] 400391 0
This will be assessed post-enrolment (1-2 weeks prior to intervention), after 7 to 8 weeks (1-2 weeks post intervention completion) and again after a further 3 months.

Eligibility
Key inclusion criteria
Participants (i) must be at least 18 years of age, (ii) have a confirmed diagnosis of stroke within the previous 6 months and no longer in hospital, (iii) self-reported cognitive difficulties and/or adjustment concerns, which are confirmed by neuropsychological and clinical assessment on pre-testing, (iv) English as preferred language of use, (v) estimated premorbid full scale IQ greater than or equal to 80, (vi) access to a technology suitable for Telehealth, and (vii) ability to attend weekly sessions over a 6 week period, and an assessment session before and immediately after the intervention, as well as at 3 month follow up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) non-English speaking background, diagnosis (ii) diagnosis of a neurodegenerative disorder, (ii) diagnosis of traumatic brain injury or other serious neurological condition eg. epilepsy or brain tumour, (iii) diagnosis of premorbid psychiatric illness (other than mood or anxiety) or (iv) severe physical, language or cognitive deficits that are not able to be otherwise supported and prevent engagement with the Telehealth intervention.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
GPower was used to calculate power for the Intervention Group x Time on our primary outcome measure, Rey Auditory Verbal Learning Test (RAVLT), as previous research indicates medium effect sizes of cognitive rehabilitation in this patient group (Miller & Radfor, 2014). With 0.8 power, to detect a conservative small to medium effect (f=.15) on this measure, a total of 74 participants is required (n=37 in each experimental Group). To account for potential dropout, an additional 6 participants will be recruited (3 in each group) giving a total of 80 participants.
Reference:
Miller, L. A., & Radford, K. (2014). Testing the effectiveness of group-based memory rehabilitation in chronic stroke patients. Neuropsychological Rehabilitation, 24(5), 721-737.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
17/05/2022
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
80
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19517 0
Port Kembla Hospital - Warrawong
Recruitment hospital [2] 19518 0
Wollongong Hospital - Wollongong
Recruitment hospital [3] 19519 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 34116 0
2500 - Wollongong
Recruitment postcode(s) [2] 34115 0
2502 - Warrawong
Recruitment postcode(s) [3] 34117 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 308620 0
Government body
Name [1] 308620 0
Illawarra Shoalhaven Local Health District
Country [1] 308620 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Research Support Office
Level 8 - Block C West, Wollongong Hospital
Loftus Street, Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 309489 0
None
Name [1] 309489 0
Address [1] 309489 0
Country [1] 309489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308552 0
University of Wollongong Ethics
Ethics committee address [1] 308552 0
Research Services Office
Level 1, Building 20
Northfields Avenue
Wollongong NSW 2522
Ethics committee country [1] 308552 0
Australia
Date submitted for ethics approval [1] 308552 0
14/05/2021
Approval date [1] 308552 0
11/08/2021
Ethics approval number [1] 308552 0
2021/ETH00971

Summary
Brief summary
This study aims to evaluate the effectiveness of a combined 6 week Cognitive Rehabilitation and Psychological intervention delivered via Telehealth in improving patient outcomes post-stroke in a pragmatic randomised wait-list controlled trial. It is expected that the proposed intervention will improve patients’ cognition, psychological wellbeing, functional abilities and QoL. Eighty participants with a diagnosis of stroke within the previous 6-months and self-reported cognitive or psychological difficulties referred to the ISLHD Rehabilitation and Medical Psychology Department by multidisciplinary teams on Rehabilitation and Neurology wards within ISLHD, will be randomised to a 6-week combined Cognitive Rehabilitation and Psychological Telehealth Intervention or Waitlist Control Group. Participants will attend an assessment session prior to the Group, immediately following the Group, and at 3 months follow up after completing group, and will be assessed with a varied of neuropsychological tests (primary outcome measure being RAVLT) and psychological wellbeing measures (DASS-21) and quality of life(SF-36) .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111110 0
Dr Kate Croaker
Address 111110 0
Unit Head Psychology
Rehabilitation and Medical Psychology department, level 3,
Port Kembla Hospital, 89-91 Cowper Street, PO Box 21 WARRAWONG NSW 2502
Country 111110 0
Australia
Phone 111110 0
+61 439 435 567
Fax 111110 0
+61 02 4223 8133
Email 111110 0
kate.croaker@health.nsw.gov.au
Contact person for public queries
Name 111111 0
Dr Kate Croaker
Address 111111 0
Unit Head Psychology
Rehabilitation and Medical Psychology department, level 3,
Port Kembla Hospital, 89-91 Cowper Street, PO Box 21 WARRAWONG NSW 2502
Country 111111 0
Australia
Phone 111111 0
+61 02 4223 8232
Fax 111111 0
+61 02 4223 8133
Email 111111 0
kate.croaker@health.nsw.gov.au
Contact person for scientific queries
Name 111112 0
Dr Kate Croaker
Address 111112 0
Unit Head Psychology
Rehabilitation and Medical Psychology department, level 3,
Port Kembla Hospital, 89-91 Cowper Street, PO Box 21 WARRAWONG NSW 2502
Country 111112 0
Australia
Phone 111112 0
+61 02 4223 8232
Fax 111112 0
+61 02 4223 8133
Email 111112 0
kate.croaker@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No – data will shared. Nil plans for contributions to meta-analysis


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.