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Trial registered on ANZCTR


Registration number
ACTRN12619000626167
Ethics application status
Approved
Date submitted
5/04/2019
Date registered
26/04/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Fatigue After STroke Educational Recovery trial (FASTER)
Scientific title
Reducing fatigue after stroke: A randomised controlled trial
Secondary ID [1] 297885 0
Nil known
Universal Trial Number (UTN)
U1111-1218-1453
Trial acronym
Fatigue After STroke Educational Recovery (FASTER)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-stroke fatigue 312258 0
Condition category
Condition code
Stroke 310804 310804 0 0
Haemorrhagic
Stroke 310805 310805 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following written informed consent, participants will be randomly assigned to receive either a single 90 minute Usual Care (UC) group session or six weekly standardised fatigue management group (FMG) sessions of 60 to 90 minutes duration per week. FMG sessions
will focus on fatigue management, sleep, exercise, nutrition and mood. Participants will receive a study-specific handouts to accompany each session, and will be asked to complete a fatigue and activity diary. Across both groups, all sessions will be run by registered clinical psychologists (or similar appropriately registered health professionals) using a brief cognitive behavioural therapy framework already tested in an earlier pilot trial. While caregivers will not attend sessions, they will also receive a handouts containing all the information covered in the respective group. All participants across both groups (and nominated family caregivers where available) will complete an in-person baseline assessment, with follow-up assessments directly after the completion of group session/s and at 3-months later. Each assessment is expected to take no longer than 60 minutes for adults with stroke, and 20 minutes for each participating family caregiver. All assessments will be administered by a research assistant 'blinded' to group status.

All intervention group sessions will be delivered by registered personnel trained in the delivery of either the intervention or usual care group session. All participants will provide informed written consent before attending any groups session or the collection of any study data. There will be no testing of new medical devices or treatments.

The brief CBT framework, altered to accommodate cognitive deficiencies common post-stroke, will emphasise compensatory strategies (i.e. energy conservation) given likely organic factors linked to PSF. This professionally guided process recognises the expertise of the group members, validates their experiences, and enables the sharing of knowledge, reflection, and experiences. Behaviour change will be achieved by goal setting, planning, and trialling fatigue management strategies in the home and community.

Standardised data collection will be achieved using a systematic competency assessment with all research assistants and clinical psychologists to be delivered and monitored by study management. On-going training and feedback will ensure sustained quality of the trial. To monitor clinical psychologists’ adherence to FMG and GSE treatment regime and fidelity, group sessions will be audio-recorded with participant’s consent and a random 10% will be independently assessed by two CBT experts. Potential therapist effects will be minimised by each clinical psychologist being trained in the delivery of either the FMG or GSE sessions. A standardised CBT quality criteria instrument will also assess adherence to CBT, FMG and GSE delivery, with additional training provided if required. Participant adherence to protocol will be monitored via diary data, session attendance, and reviews at each session.



Intervention code [1] 314114 0
Behaviour
Intervention code [2] 314197 0
Treatment: Other
Comparator / control treatment
The UC session will offer broad general stroke education (i.e. what is stroke?) with limited focus on PSF. There will be opportunities for mutual understanding of stroke by sharing experiences on specific topics (i.e., nutrition, exercise). Usual care sessions (60-90 minutes) will also be delivered by Clinical Psychologists (or other suitable registered health professionals)
Control group
Active

Outcomes
Primary outcome [1] 319650 0
Aim 1 (Primary objective) - to assess the effectiveness of the FMG intervention on subjective experiences of PSF severity immediately after the intervention (6-weeks) compared to a UC usual care group using Fatigue Severity Scale - 9.
Timepoint [1] 319650 0
Immediately after the intervention (6-weeks)
Primary outcome [2] 319759 0
to assess the effectiveness of the FMG intervention on subjective experiences of PSF dimensionality immediately after the intervention (6-weeks) compared to a Usual Care (UC) group using the Multidimensional Fatigue Inventory - 20.
Timepoint [2] 319759 0
immediately after the intervention (6-weeks)
Secondary outcome [1] 369016 0
Aim 2 (Secondary objective) – to evaluate the effectiveness of the FMG intervention on objective fatigue at 6-weeks following the start of intervention compared to a UC group using computer-based tests of attentional control.

The computer-based tasks of attentional control are will include either a visual oddball task or an effortful decision-making task depending on feasibility for stroke patinets and potential floor and ceiling effects.

A 3-stimulus novelty visual oddball task would provide robust data in a brief 30-minute session. Behavioural data will include response times and correct/incorrect responses to a target stimulus. Mental fatigue will be evident in slower response times and increasing error rates. For each stimulus and response type 3 event-related potentials are quantified: 1) Attentional fatigue, indexed by increases in onset latency for target stimuli; 2) Distraction by non-target stimuli (attentional fatigue), indexed by increases in amplitude to novelty.

An effort-based decision-making task may better detect declines in performance due to cognitive fatigue. But considerably more trials are needed (to obtain stable data and avoid confounding or poor signal/noise ratios) and effort-based floor effects must be avoided.

Therefore, we are currently testing a more effortful decision-making task (90-120-minute visual memory/selective attention in stroke patients. If feasible, this task will replace the oddball task.

Timepoint [1] 369016 0
Immediately after intervention (6-weeks)
Secondary outcome [2] 369435 0
Aim 3 (Secondary objective) – to evaluate the effectiveness of the FMG intervention on subjective and objective fatigue at 3-months following the start of the intervention compared to a UC group using both primary outcome measures (FSS-9 and MFI-20) and computer-based tests of attentional control, as discussed above.
Timepoint [2] 369435 0
3-months following the start of the intervention
Secondary outcome [3] 369436 0
Aim 4 (Secondary objective) – to evaluate the effectiveness of the FMG intervention on stroke survivor HRQoL and ADL, carer HRQoL, and the cost-effectiveness of the FMG intervention at each follow-up compared to a UC group using the Short-Form 36 and the Barthel Index. Cost effectiveness evaluation will be analysed in accordance with the Consolidated Health Economic Evaluation Reporting Guidelines. Primary outcome will be the FSS-9 total score and the MFI-20 general subscale. Secondary outcome quality adjusted life years will be generated from the SF-36 questionnaire from baseline and 3-months post-intervention, using standard procedures. Further analysis will determine any cost offsets by cost savings generated from reduced health service use during follow-up.
Timepoint [3] 369436 0
immediately after the intervention (6-weeks) and 3-months following the start of the intervention.

Eligibility
Key inclusion criteria
To be eligible to take part in the study, potential participants must meet the following criteria:
(a) CT/MRI confirmed stroke to enable exclusion of stroke-mimic conditions;
(b) clinically significant fatigue at 3 to 18-months after first-ever stroke;
(c) residing in the study areas (Auckland, Waikato) to ensure feasibility;
(d) ability to converse in English to support understanding of group discussions and materials; and
(e) able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-stroke fatigue, given differing aetiology requiring a different intervention approach; significant cognitive (MMSE <23 or Montreal Cognitive Assessment <26) or behavioural impairments (e.g. agitation, major depressive criteria measured by the CES-D revised - depression scale); significant disability (mRS 4-5) due to high dependence for basic Acitivities of Daily Living making some Fatigue Severity Scale (FSS) items not applicable (i.e. ‘my fatigue prevents sustained physical functioning) making it difficult to accurately detect changes in fatigue; identified causes of chronic fatigue (e.g. sleep apnea); medical instability, or other health condition (e.g. dementia, drug/alcohol abuse) that would preclude full participation; participation in another clinical trial; and a known history of stroke.

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)
Central minimisation randomisation using free online programme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To minimise confounding bias, 1:1 allocation randomisation will ensure groups are balanced for these key prognostic factors: age (<65; 65+); gender; stroke disability (modified Rankin Sacle: no significant disability 0-1; slight to moderate disability 2-3); and depression (CES-Depression revised total depression: no depression <16; depression =16+).
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A total sample size of 200 (100 per group, allowing for 20% drop-out) will have
85% power (2-sided p=0.05) to detect minimally clinically important differences of 0.60[19] (SD=1.27) in FSS and 1.70 points (SD=3.6) in MFI-20 between the FMG and GSE groups at 3-months. A 1.70 point difference in general fatigue scores (a 34% change on a 5-item scale), for example, may reflect a change from agreeing with the statement ‘get little done in a day’ to agreeing with ‘do a lot in a day’.

Primary analyses will utilise data from all time points but will focus on identifying the key differences between intervention and control groups at 6-weeks. Secondary analyses will model changes over time from baseline to 6-weeks and 3-months between FMG and UC groups and within each group, accounting for potential confounders (arising from any imbalance between the two trial arms) and adjusting for clinically important covariates.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 21387 0
New Zealand
State/province [1] 21387 0
Auckland & Waikato

Funding & Sponsors
Funding source category [1] 302408 0
Government body
Name [1] 302408 0
Health Research Council of New Zealand
Address [1] 302408 0
Level 3/110 Stanley St, Grafton, Auckland 1010
New Zealand
Country [1] 302408 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive
Northcote,
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 302300 0
None
Name [1] 302300 0
Address [1] 302300 0
Country [1] 302300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303077 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 303077 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
New Zealand
Ethics committee country [1] 303077 0
New Zealand
Date submitted for ethics approval [1] 303077 0
07/08/2018
Approval date [1] 303077 0
02/04/2019
Ethics approval number [1] 303077 0
18/CEN/279

Summary
Brief summary
Fatigue is a common and persistent deficit in up to 92% of stroke survivors that can
negatively impact functioning. It is imperative that new strategies be developed to tackle post-stroke fatigue, a debilitating but often overlooked sequelae of stroke. Cognitive and behavioural (educational) interventions for fatigue have been successful in other conditions (e.g. traumatic brain injury, multiple sclerosis, chronic fatigue syndrome), but have not been fully examined in the context of stroke. Building on promising findings from our pilot study, this full-scale randomised controlled trial aims to assess the effect of the intervention on reducing physical, psychological and mental fatigue and improving quality of life in stroke survivors. Family carer quality of life and burden, as well as impact of the intervention on other functional outcomes and costs will also be examined. This trial has potential to improve quality of life and day-to-day functioning for stroke survivors and their families.
Trial website
https://nisan.aut.ac.nz/research-programmes/stroke/current-projects/faster-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92386 0
Dr Kelly Jones
Address 92386 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 1142
New Zealand
Country 92386 0
New Zealand
Phone 92386 0
+64 9 921 9999
Fax 92386 0
Email 92386 0
kelly.jones@aut.ac.nz
Contact person for public queries
Name 92387 0
Dr Kelly Jones
Address 92387 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 1142
New Zealand
Country 92387 0
New Zealand
Phone 92387 0
+64 9 921 9999
Fax 92387 0
Email 92387 0
kelly.jones@aut.ac.nz
Contact person for scientific queries
Name 92388 0
Dr Kelly Jones
Address 92388 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 1142
New Zealand
Country 92388 0
New Zealand
Phone 92388 0
+64 9 921 9999
Fax 92388 0
Email 92388 0
kelly.jones@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent does not cover sharing of individual-level data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results