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Trial registered on ANZCTR


Registration number
ACTRN12617000618358
Ethics application status
Approved
Date submitted
26/04/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth delivery of memory rehabilitation following stroke.
Scientific title
Efficacy of telehealth delivery of memory rehabilitation following stroke.
Secondary ID [1] 291748 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 302960 0
Memory deficits 302961 0
Condition category
Condition code
Stroke 302428 302428 0 0
Ischaemic
Stroke 302429 302429 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Making the Most of Your Memory

The Making the Most of your Memory is a manualised six-week memory skills program. It has been designed for small rehabilitation groups and validated for people with stable neurological disorders and everyday memory complaints. For the purposes of this project, the program has been adapted for delivery to participants on an individual basis, as well as delivery via internet videoconferencing (i.e. software programs such as Skype or Zoom).

Participants will attend one memory skills training session per week for a six week period. The sessions will be up to two hours in duration, based on the needs of the participant and level of interaction. Sessions will be administered by Provisional Psychologists on Clinical Psychology or Neuropsychology placement at the Monash Psychology Centre (MPC), supervised by Dr Dana Wong. Participants will engage with the program either via group delivery at the MPC, individually face-to-face at the MPC, or individually via internet videoconferencing. Therefore there will be four arms to the study: group face-to-face, individual face-to-face, individual internet delivery, and a wait-list control.

Sessions will cover psychoeducation regarding the impact of stroke on memory and the contributions from lifestyle factors such as diet, exercise, sleep, and stress. Participants will also be provided with comprehensive training in a range of internal strategies, use of external tools, and environmental adjustments designed to support everyday memory functioning. The program also includes exercises to be discussed and carried out either in-session or as homework between sessions, designed to encourage practise and generalisation of skills.

Adherence to the requirements of the program will be monitored by shared spreadsheets and calendars accessible by related clinicians and the researcher, in order to register session attendance.

A booster session will be offered to participants on a randomised allocation, at a follow-up point approximately 6 weeks following completion of the program. The booster session will run for up to 2 hours (based on the needs of the participant and level of interaction) and will follow the same format as the participant's earlier sessions (i.e. group face-to-face, individual face-to-face, or individual internet delivery). The booster session will be less structured than the earlier sessions, and will focus on goals and strategies that will have been highlighted through discussion as most relevant to the participant.

A single session will also be offered to a close friend or family member during the process, in order to provide additional support to the participant at home. This session will run for approximately 1.5 hours, and will follow the same format as their close-other (i.e. group/individual face-to-face, or individual internet delivery). The session will comprise a condensed summary of the psychoeducation, lifestyle factors, internal memory strategies and environmental adjustment sections of the memory skills program.

All participants will also be asked to complete a range of objective and subjective assessment tasks designed to measure memory functioning immediately prior to the rehabilitation, immediately following the rehabilitation, and at six-week and twelve-week follow up points.
Intervention code [1] 297858 0
Rehabilitation
Intervention code [2] 297910 0
Treatment: Other
Intervention code [3] 297911 0
Lifestyle
Comparator / control treatment
Participants allocated to the waitlist control condition are placed on a waiting list for a 12 week period before commencement of their intervention. These participants receive either group or individual rehabilitation treatment. These participants will receive the carer/close-other session, but will not receive the booster session.
Control group
Active

Outcomes
Primary outcome [1] 301843 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] 301843 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] 334007 0
Total score on Royal Prince Alfred Prospective Memory Task (RPA-ProMem)
Timepoint [1] 334007 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] 334008 0
Total self reported memory failures on the Everyday Memory Questionnaire-Revised
Timepoint [2] 334008 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] 334009 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] 334009 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] 334010 0
Visual memory and learning T-scores on the Brief Visuospatial Memory Test Revised (BVMT-R)
Timepoint [4] 334010 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] 334011 0
Other reports of patient memory failure assessed on the other version of the Comprehensive Assessment of Prospective Memory (CAPM-other)
Timepoint [5] 334011 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] 334012 0
Quality of life as assessed by the Assessment of Quality of Life (AQoL-8D)
Timepoint [6] 334012 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] 334013 0
Anxiety total scores on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [7] 334013 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] 334014 0
Self reported prospective memory failures on the Comprehensive Assessment of Prospective Memory (CAPM)
Timepoint [8] 334014 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] 334015 0
Depression total score on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [9] 334015 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
Inclusion criteria comprise the following:
- Diagnosis of stroke occurring at least three months prior to the intervention start date
- Subjective or objective memory complaints
- Sufficient English language and cognition to ensure successful and valid completion of outcome measures and rehabilitation
For telehealth group condition:
- Access to a computer with internet access and video camera, plus sufficient computer proficiency to operate Zoom videoconferencing software program and to complete online questionnaires.
For face-to-face group condition:
- Ability to attend weekly memory groups held at Monash Psychology Centre, Notting Hill, Victoria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria comprise the following:
- Any cognitive or language impairment of a severity level to preclude valid completion of assessment measures or inability to sufficiently comprehend and engage with the content of the rehabilitation program;
- History of other neurological conditions including evidence of a progressive neurodegenerative process

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to face-to-face intervention delivery or telehealth delivery will not be concealed as group will often be determined by residence location and distance/availability to attend intervention sessions face-to-face.
Allocation to booster session or no-booster session groups will follow allocation concealment:
Random permuted blocks will be used. Randomisation will be performed by a Monash-Epworth Rehabilitation Research Centre employee who is independent of the study. The research centre employee will utilise an online randomization program to create allocation sequences, which will be transcribed onto cards, placed into opaque envelopes, and passed into the Study Coordinator. Randomization lists will be separately prepared for face-to-face and telehealth participants to ensure equal numbers across strata. Staff conducting follow-up assessments will be masked to group membership and independent of treatment delivery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The research centre employee will utilise an online randomization program to create allocation sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A 4 (group delivery, individual face-to-face delivery, telehealth delivery, waitlist control) x 4 (baseline, post intervention, follow up, further follow-up) mixed model ANOVA will be conducted.

G*power calculations (version 3.1) for the above design, with an expectedmedium effect size (conservative estimate based upon recent meta analytic findings), suggest that a sample size of 80 would achieve 80% power, at an alpha level of .05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
21/12/2018
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296030 0
University
Name [1] 296030 0
Monash University
Country [1] 296030 0
Australia
Funding source category [2] 296278 0
Charities/Societies/Foundations
Name [2] 296278 0
Stroke Foundation
Country [2] 296278 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences
18 Innovation Walk, Clayton Victoria 3800
Country
Australia
Secondary sponsor category [1] 294918 0
None
Name [1] 294918 0
Nil
Address [1] 294918 0
Nil
Country [1] 294918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297289 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 297289 0
Ethics committee country [1] 297289 0
Australia
Date submitted for ethics approval [1] 297289 0
17/12/2015
Approval date [1] 297289 0
21/12/2015
Ethics approval number [1] 297289 0
15037A

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

Contacts
Principal investigator
Name 73594 0
Mr David Lawson
Address 73594 0
School of Psychological Sciences
18 Innovation Walk, Monash University, Clayton, VIC 3800
Country 73594 0
Australia
Phone 73594 0
+61 3 9905 3965
Fax 73594 0
+61 3 9905 3948
Email 73594 0
[email protected]
Contact person for public queries
Name 73595 0
David Lawson
Address 73595 0
School of Psychological Sciences
18 Innovation Walk, Monash University, Clayton, VIC 3800
Country 73595 0
Australia
Phone 73595 0
+61 3 9905 3965
Fax 73595 0
+61 3 9905 3948
Email 73595 0
[email protected]
Contact person for scientific queries
Name 73596 0
Dana Wong
Address 73596 0
School of Psychological Sciences
18 Innovation Walk, Monash University, Clayton, VIC 3800
Country 73596 0
Australia
Phone 73596 0
+61 3 9905 3933
Fax 73596 0
+61 3 9905 3948
Email 73596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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