Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000826145
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
7/06/2019
Date last updated
7/06/2019
Date data sharing statement initially provided
7/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Too tired to recover: Evaluation of a post-stroke fatigue management guideline
Scientific title
Too tired to recover: Evaluation of a post-stroke fatigue management guideline on the fatigue experience of stroke patients.
Secondary ID [1] 296880 0
Nil known
Universal Trial Number (UTN)
U1111-1225-5940
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-stroke fatigue 310812 0
Condition category
Condition code
Stroke 309485 309485 0 0
Haemorrhagic
Stroke 309486 309486 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this pilot study is twofold: 1) to evaluate the effectiveness of a novel fatigue management guideline for reducing mental fatigue and improving outcomes in adults post stroke; 2) to evaluate the usefulness of a novel fatigue management guideline for enhancing management of mental fatigue in clinical practice; using an exploratory randomised controlled trial (RCT) with two conditions: an active fatigue management (including education and use of newly developed clinical tools) and a standard care group. One-on-one treatment will be carried out by a qualified Ooccupational Therapist in the Metro North Hospital and Health Service (MNHHS) Community Based Rehabilitation Team for a 10 week intervention period consisting of 1 hour weekly sessions. Participants enrolled in the treatment arm will benefit from incorporation of new clinical tools designed specifically for this study to be used by treating Occupational Therapists during therapy, including a routine fatigue management tool, matrix tool, and mental fatigue client education booklet. These tools would help clients and therapists prioritise activities and decisions, to avoid excessive multitasking and decision making, as well as provide external memory strategies to reduce cognitive load, and energy conservation strategies for optimal energy use. Participants randomly assigned to standard care (control group) will not receive education about fatigue or focus on mental fatigue in therapy, but will receive a handout from the stroke foundation on fatigue after stroke, and may receive compensatory strategies for cognitive or fatigue symptoms that are considered within the realm of routine practice. Adherence to intervention sessions will be monitored via a session attendance checklist.
Treating Occupational Therapists were trained in the use of the new clinical tools 1 month prior to recruitment to the study, via a 2 hour inservice presentation which involved practicing using the following tools: The routine tool, the matrix tool and the mental fatigue client education booklet. The routine tool encourages the use of daily habits to promote breaks, relaxation and plans for optimal energy use. An electronic routine tool was developed for therapists to conveniently develop customisable daily routines for clients, and provides an option to monitor client’s adherence to habits to ensure goals are realistic and achievable within a 10 week time frame. The matrix tool was developed to help clients prioritise activities and decisions, to avoid excessive multitasking and decision making, and refer them to external memory strategies to reduce cognitive load.
Intervention code [1] 313302 0
Rehabilitation
Intervention code [2] 313303 0
Behaviour
Intervention code [3] 313304 0
Treatment: Other
Comparator / control treatment
Patients randomly assigned to standard care will not receive education about fatigue or focus on mental fatigue in therapy but may receive some compensatory strategies for cognitive or fatigue-related symptoms that are considered routine Occupational Therapy practice, based on the Australian Stroke Foundation Guidelines for Fatigue After Stroke.
Control group
Active

Outcomes
Primary outcome [1] 318613 0
Levels of mental fatigue will be assessed using the Multidimensional Fatigue Symptom Inventory Short Form: MFSI-SF.
Timepoint [1] 318613 0
10 weeks post-intervention commencement.
Primary outcome [2] 318614 0
Self-efficacy for daily living will be assessed using the Daily Living Self-Efficacy Scale - DLSES.
Timepoint [2] 318614 0
10 weeks post-intervention commencement
Primary outcome [3] 320071 0
Quality of life outcomes will be assessed using the Short Form Health Survey of the Medical Outcomes Study (SF-36)
Timepoint [3] 320071 0
10 weeks post-intervention commencement
Secondary outcome [1] 365527 0
Patients’ level of satisfaction with fatigue management tool usefulnes will be assessed using a short survey of open-ended questions. This survey was designed specifically for the study and is not validated.
Timepoint [1] 365527 0
10 weeks post-intervention commencement
Secondary outcome [2] 365528 0
Therapists’ level of satisfaction with clinical utility of fatigue management guidelines will be assessed using a short survey of open-ended questions. This survey was designed specifically for the study and is not validated.
Timepoint [2] 365528 0
10 weeks post-intervention commencement

Eligibility
Key inclusion criteria
a) diagnosis of stroke; b) aged over 40 years; c) able to communicate in English; d) fatigue issues identified on care plan.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) pre-morbid major psychiatric or neurological disorder; b) significant visual impairment; or c) significant hearing impairment; d) severe aphasia or other communication disorder including difficulty reading or understanding written information; e) severe cognitive impairment.

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)
Eligible respondents who provide informed consent will be randomised to receive either active fatigue management or standard care. A random number generator will be used to allocate participants to treatment group. Opaque envelopes containing each concealed allocation will be sequentially drawn by therapists administering treatment at each site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to allocate participants to treatment group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
Statistical analyses will be conducted to compare the treatment group with standard care using repeated measures ANOVA. Intention to treat analysis will be used. Missing data will be examined to determine if missing completely at random and multiple imputation implemented if required. An alpha level of .05 will be set for statistical significance. A minimum of 36 participants are required to achieve power of .90 to detect a medium effect size (f = .25; G*Power 3). This pilot will recruit 40 post stroke patients (20 per condition).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/05/2019
Date of last participant enrolment
Anticipated
31/10/2019
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
40
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12848 0
Chermside Community Health Centre - Chermside
Recruitment hospital [2] 12849 0
North Lakes Health Precinct - North Lakes
Recruitment hospital [3] 12850 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 12851 0
Caboolture Community Health Centre - Caboolture
Recruitment postcode(s) [1] 25324 0
4032 - Chermside
Recruitment postcode(s) [2] 25325 0
4509 - North Lakes
Recruitment postcode(s) [3] 25326 0
4020 - Redcliffe
Recruitment postcode(s) [4] 25327 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 301451 0
Government body
Name [1] 301451 0
Metro North Health and Hospital Service
Country [1] 301451 0
Australia
Funding source category [2] 301591 0
University
Name [2] 301591 0
University of Queensland
Country [2] 301591 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 301141 0
Government body
Name [1] 301141 0
Metro North Hospital & Health Service
Address [1] 301141 0
Chermside Community Based Rehabilitation Team
Building 26, 490 Hamilton Rd.,
Chermside QLD 4036
Country [1] 301141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302185 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 302185 0
Ethics committee country [1] 302185 0
Australia
Date submitted for ethics approval [1] 302185 0
Approval date [1] 302185 0
28/11/2018
Ethics approval number [1] 302185 0

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

Contacts
Principal investigator
Name 89406 0
Mr Anthony Walsh
Address 89406 0
Chermside Community Based Rehabilitation Team
Building 26, 490 Hamilton Rd
Chermside QLD 4036
Country 89406 0
Australia
Phone 89406 0
+61 7 31396051
Fax 89406 0
Email 89406 0
[email protected]
Contact person for public queries
Name 89407 0
Anthony Walsh
Address 89407 0
Chermside Community Based Rehabilitation Team
Building 26, 490 Hamilton Rd
Chermside QLD 4036
Country 89407 0
Australia
Phone 89407 0
+61 7 31396051
Fax 89407 0
Email 89407 0
[email protected]
Contact person for scientific queries
Name 89408 0
Hannah Gullo
Address 89408 0
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 89408 0
Australia
Phone 89408 0
+61 7 33653004
Fax 89408 0
Email 89408 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
It is anticipated that the overall (not individual) results of this evaluation will be de-identified, summarised and published in an appropriate peer-reviewed journal.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
998Study protocol    376587-(Uploaded-09-01-2019-17-18-22)-Study-related document.docx
999Informed consent form    376587-(Uploaded-09-01-2019-17-18-46)-Study-related document.docx



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.