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Trial registered on ANZCTR


Registration number
ACTRN12619000823178
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
7/06/2019
Date last updated
6/04/2020
Date data sharing statement initially provided
7/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of different interventions designed to maintain the benefits following a group-based memory rehabilitation program in stroke patients.
Scientific title
Enhancing the effects of post-stroke memory rehabilitation:
A feasibility trial of two e-Health interventions to sustain the benefits of a memory skills group.
Secondary ID [1] 297923 0
N/A
Universal Trial Number (UTN)
Trial acronym
Memory-SuSTAIN (Memory Strategy Skills Training Applied IN the long term)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 312310 0
Memory deficits 312311 0
Condition category
Condition code
Stroke 310872 310872 0 0
Haemorrhagic
Stroke 310873 310873 0 0
Ischaemic
Physical Medicine / Rehabilitation 310874 310874 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to commencing in the trial, participants will have completed a six-week memory skills group program. The group program comprises one two-hour session each week (including breaks) in groups of 3-8 people who report memory difficulties after experiencing an acquired brain injury (ABI). Sessions are facilitated in-person by qualified clinicians. Program content includes psychoeducation regarding memory functioning, practical training in internal and external compensatory memory strategies, and information about relevant impacts to memory functioning from lifestyle factors such as diet, sleep, and exercise. Interactive in-session exercises and between-session homework tasks are included to encourage practice and application of trained skills and strategies in everyday contexts.

All memory skills group sessions will be video recorded throughout the study period, for treatment fidelity checks of a random selection of sessions by an independent expert. Treatment fidelity monitoring will include measures of adherence (using a session content checklist) and competence (using the eNACT Group Facilitation Competency Checklist).

At the conclusion of the memory group program, interested participants will be contacted by study staff to be formally enrolled in the Memory-SuSTAIN study and randomised into one of the following two study arms (or a control condition, consisting of usual care involving no active follow-up maintenance):

Arm 1: Telehealth booster sessions
Participants in the Booster Sessions condition will receive three fortnightly sessions of one-hour duration each, with a trained clinician. Sessions will comprise:
• Checking the progress of rehabilitation goals (previously negotiated with memory group clinicians);
• Reviewing and consolidating key compensatory and lifestyle strategies covered during the memory group program;
• Expanding the number and range of everyday situations to which these memory strategies could be applied; and
• Addressing any barriers to ongoing implementation of strategies.

Booster sessions will occur remotely via videoconferencing using Zoom, a freely available software program facilitating Internet-enabled videoconferencing. Booster sessions will also be video recorded and treatment fidelity checks conducted by an independent expert.

Arm 2: SMS/Email Reminders
Participants in the SMS/Email Reminder condition will receive one strategy message per week for six weeks, sent either to their mobile phone as a text message or to a nominated email address, depending on each participant’s preference. Reminder messages will prompt participants to use their three most relevant strategies learned during the memory group program.

Following group allocation, participants in the SMS/Email Reminders condition will be asked to nominate their three most useful personally salient strategies from a list of all strategies taught in the memory skills group. These strategies will inform the range of reminder prompts that they receive. Strategies will be identified from a list covering the following areas:

Internal Strategies:
o Using repetition to enhance encoding (mental rehearsal, asking others to repeat, re-reading text);
o Using association to enhance retrieval;
o Route-finding strategies: Paying attention to key features to enhance encoding;
o Using context to assist recall;
o Word-finding and conversations: focusing on meaning, using association, and descriptions;
o Learning and recalling names: using alphabet search, association, and elaboration;

External Strategies:
o Optimising the home environment: decreasing distractions, reducing clutter;
o Using note-taking, diaries, calendars, physical reminders, and alarms;
o Using smartphones and electronic devices;
o Using checklists for complex tasks.

Messages will be delivered using the iVERVE platform, an electronic automated messaging system designed and developed by Cadilhac et al. (2018) for message-based e-health interventions. iVERVE will store a bank of strategy reminder messages and securely extract de-identified participant data (selected strategies matched with each relevant participant’s nominated phone number or email address) from a secure web-based database management system (REDCap; Harris et al., 2009). Study data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data capture tools hosted and managed by Helix (Monash University; Harris et al., 2009). REDCap is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. Automated messages will be sent to participants at designated times, once per week for six weeks.
Intervention code [1] 314144 0
Rehabilitation
Intervention code [2] 314145 0
Lifestyle
Comparator / control treatment
All participants will have completed the memory group program. Following completion of the program, participants will be randomised into one of three conditions: two different intervention conditions and a No Active Maintenance condition. Commencing at six weeks after completion of the memory program, the intervention conditions will start for participants randomised into those conditions. and run for a six-week period. During this phase, participants in the No Active Maintenance condition will not be contacted by study staff for any follow-up or maintenance purpose, with the exception of a reminder message for the next follow-up outcome assessment.
Control group
Active

Outcomes
Primary outcome [1] 319695 0
Change in Goal Attainment Scaling (GAS) score.
Timepoint [1] 319695 0
Primary outcome is measured at baseline (T0: prior to memory group), post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24)
Secondary outcome [1] 369200 0
Subjective lapses in everyday memory using the Everyday Memory Questionnaire - Revised (EMQ-R).
Timepoint [1] 369200 0
Measured at baseline (T0: prior to memory group), post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).
Secondary outcome [2] 369201 0
Self-reported memory-related use of internal and external strategies using the Strategy Use Checklist.
Timepoint [2] 369201 0
Measured at baseline (T0: prior to memory group), post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).
Secondary outcome [3] 369202 0
Functional memory performance using the Rivermead Behavioural Memory Test – Third edition (RBMT-3).
Timepoint [3] 369202 0
Measured post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).
Secondary outcome [4] 369203 0
Self-reported quality of life using the Valued Living Questionnaire (VLQ).
Timepoint [4] 369203 0
Measured post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).
Secondary outcome [5] 369204 0
Self-reported social role limitation and community participation using the 6) Community Integration Questionnaire (CIQ).
Timepoint [5] 369204 0
Measured post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).
Secondary outcome [6] 370407 0
Participant-level resource use will be obtained using the Adapted Resource Use Questionnaire for Stroke.
Timepoint [6] 370407 0
Measured post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).
Secondary outcome [7] 370408 0
Service-level program delivery costs for each intervention arm will be estimated as a composite outcome (e.g. costs of staff time to do telehealth sessions or setup the SMS program; costs of equipment; SMS service costs, etc.)
Timepoint [7] 370408 0
Measured post-memory group (T1: @ Week 6), pre-intervention (T2: @ Week 12), post-intervention (T3: @ Week 18), and follow-up (T4: @ Week 24).

Eligibility
Key inclusion criteria
Participants will satisfy the following criteria:
1. Adults (age at least 18 years);
2. Primary diagnosis of stroke as determined by medical records;
3. At least 3 months post-stroke;
4. Everyday memory complaints, reported by self or other;
5. Sufficient cognitive and English language skills to participate in a memory skills group;
6. Completion of a memory skills group program at any of the participating clinical sites (defined as attending at least 4 of the 6 memory group sessions);
7. Access to a computer with a webcam and internet connection; and
8. Access to either SMS text messaging via a mobile phone with active service, or an active email service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe psychiatric illness
2. Known presence of a neurodegenerative conditions (e.g. dementia), severe mental health conditions, or other known neurological disorder impacting cognition
3. Major illness and unlikely to survive up to final follow-up assessment
4. Current participation in other individual rehabilitation sessions focusing on memory or other cognitive functions.

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)
Group allocation will take place within REDCap (a secure, web-based application designed to support data capture for research projects, including a randomisation module). The randomisation schedule is first generated using Stata, before being uploaded to REDCap using the randomisation module, which is designed to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by the Research Officer using Stata Version 15 (StataCorp, 2017). The sequence will be generated using random block sizes with 6 allocations per block (2 per condition), stratified by health service site to ensure equal distribution across sites.
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
For the effectiveness aim of the study:
Pairwise comparisons and linear mixed models will be used to explore between-group differences at each time point in clinical outcomes. The effect size of each maintenance condition, defined as the magnitude of change from T1-T4, will be estimated with Cohen’s d based on output from regression models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2019
Actual
16/12/2019
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
45
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13576 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 13577 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 13578 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 13579 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment postcode(s) [1] 26230 0
3084 - Heidelberg
Recruitment postcode(s) [2] 26231 0
3050 - Parkville
Recruitment postcode(s) [3] 26232 0
3021 - St Albans
Recruitment postcode(s) [4] 26234 0
3215 - North Geelong

Funding & Sponsors
Funding source category [1] 302439 0
Charities/Societies/Foundations
Name [1] 302439 0
Stroke Foundation
Country [1] 302439 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora, Victoria, 3086.
Country
Australia
Secondary sponsor category [1] 302341 0
None
Name [1] 302341 0
Address [1] 302341 0
Country [1] 302341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303108 0
Monash Health HREC
Ethics committee address [1] 303108 0
Ethics committee country [1] 303108 0
Australia
Date submitted for ethics approval [1] 303108 0
02/04/2019
Approval date [1] 303108 0
06/06/2019
Ethics approval number [1] 303108 0
HREC/51287/MonH-2019-170559

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

Contacts
Principal investigator
Name 92502 0
Dr Dana Wong
Address 92502 0
Department of Psychology and Counselling
School of Psychology and Public Health
La Trobe University,
Kingsbury Drive, Bundoora VIC 3086
Country 92502 0
Australia
Phone 92502 0
+61 3 9479 5079
Fax 92502 0
Email 92502 0
[email protected]
Contact person for public queries
Name 92503 0
David Lawson
Address 92503 0
Department of Psychology and Counselling
School of Psychology and Public Health
La Trobe University,
Kingsbury Drive, Bundoora VIC 3086
Country 92503 0
Australia
Phone 92503 0
+61 3 9479 1679
Fax 92503 0
Email 92503 0
[email protected]
Contact person for scientific queries
Name 92504 0
Dana Wong
Address 92504 0
Department of Psychology and Counselling
School of Psychology and Public Health
La Trobe University,
Kingsbury Drive, Bundoora VIC 3086
Country 92504 0
Australia
Phone 92504 0
+61 3 9479 5079
Fax 92504 0
Email 92504 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1825Study protocol    377361-(Uploaded-09-04-2019-15-10-21)-Study-related document.pdf
1826Informed consent form    377361-(Uploaded-09-04-2019-15-11-52)-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
No additional documents have been identified.