Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000387527
Ethics application status
Approved
Date submitted
7/03/2024
Date registered
3/04/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a novel co-designed ‘Fatigue-o-meter' to tackle post-stroke fatigue
Scientific title
Evaluation of a novel co-designed psychoeducational tool (the ‘Fatigue-o-meter') to treat post-stroke fatigue
Secondary ID [1] 311690 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 333151 0
Fatigue 333152 0
Condition category
Condition code
Stroke 329849 329849 0 0
Ischaemic
Stroke 329850 329850 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a psychoeducational tool that has been co-designed with survivors of stroke, caregivers, health professionals, and researchers.
The tool is a booklet that contains information about the topics listed below and interactive questions as self-reflection prompts. Participants will meet online with a health professional once per week, for an 8-week intervention period to work through the 8 different chapters in the booklet.
Topics covered during the 8 sessions include:
Week 1. Discussion about the following topics: Learning about your fatigue and how it may protect you; what does fatigue look like after stroke?; Neuroplasticity and the brain;
Week 2. Things that make your fatigue go up or down; Discussion and guided questions for self-reflection of the individual aggravating and easing factors for fatigue.
Week 3. Discussion and guided self-reflection questions about the participants fatigue;
and their alert zone (what levels of fatigue they are comfortable / uncomfortable with);
Week 4. Discussion and guided questions for self-reflection and action planning about how fatigue is variable and can change. In this chapter "Planning for fatigue and using the Fatigue-o-meter" the Fatigue-o-meter is a visual tool that allows participants to "rate their fatigue" across the following zones: no fatigue, alert zone, wipe-out zone.
Week 6, Goal setting: Individual goal setting around fatigue levels and participation guided by the health professional.
Week 7, Refining your plan for fatigue - review of goal setting, modification as required.
Week 8: Putting it all together - final review of goal setting and action planning for the future.

A health professional will use the chapters in the booklet to guide conversations and self-reflection during 8 one-on-one sessions across an 8-week duration. Each session will be around 30 minutes duration.

Participants will have the choice of receiving the education sessions one-on-one face-to-face at a clinic or one-on-one via videoconferencing.

While post-stroke fatigue shares some common features, every person's experience is personal. The intervention will be personalized depending on each participant's experience of post-stroke fatigue. For example, participants will share different and personal triggers for their fatigue and the health professional will assist them to problem solve around these personal factors and develop personal strategies accordingly.

Adherence to the program and the content delivered in each session will be monitored by the health professional delivering the intervention and subsequently checked by another member of the research team.

The three study phases are as follows:
(1) Baseline phase (A):
Randomization: The duration of the baseline phase will be randomised for each participant (internal validity) in the dyad as either 3 or 4 weeks. By applying baselines of varying length, the effects of the intervention can be assessed for replication in a way that demonstrates experimental control.
(2) Intervention phase (B):
The intervention will be delivered over an 8-week duration comprising of 8 individual education sessions with a health professional.
(3) Follow-up phase (A1):
The follow-up phase will be a 6-week duration with no health professional contact.

During the baseline and follow-up phases (A and A1) participants will record their fatigue levels each day at a standardised time of day. During the intervention phase (B) participants will only complete the intervention sessions described above.
Intervention code [1] 328151 0
Rehabilitation
Intervention code [2] 328152 0
Behaviour
Intervention code [3] 328153 0
Treatment: Other
Comparator / control treatment
We are using a Single Case Experimental Design (with multiple baselines). Therefore we are using within participant control, with the added control of comparison with a multiple baseline across participants.
Control group
Active

Outcomes
Primary outcome [1] 337618 0
Fatigue
Timepoint [1] 337618 0
Daily during baseline monitoring phase (A) 3 or 4 weeks duration depending on randomisation
and daily during the follow-up phase (A1) 6 weeks duration.
Secondary outcome [1] 432538 0
Fatigue
Timepoint [1] 432538 0
Study inception (week 0), end baseline (week 3 or 4 depending on randomisation), end intervention (week 11 or 12 depending on randomisation), end follow-up (week 17 or 18 depending on randomisation)
Secondary outcome [2] 432539 0
Quality of life
Timepoint [2] 432539 0
Study inception (week 0), end baseline (week 3 or 4 depending on randomisation), end intervention (week 11 or 12 depending on randomisation), end follow-up (week 17 or 18 depending on randomisation)
Secondary outcome [3] 432540 0
Self-efficacy
Timepoint [3] 432540 0
Study inception (week 0), end baseline (week 3 or 4 depending on randomisation), end intervention (week 11 or 12 depending on randomisation), end follow-up (week 17 or 18 depending on randomisation)
Secondary outcome [4] 432541 0
Participation
Timepoint [4] 432541 0
Study inception (week 0), end baseline (week 3 or 4 depending on randomisation), end intervention (week 11 or 12 depending on randomisation), end follow-up (week 17 or 18 depending on randomisation)
Secondary outcome [5] 432542 0
Mood
Timepoint [5] 432542 0
Study inception (week 0), end baseline (week 3 or 4 depending on randomisation), end intervention (week 11 or 12 depending on randomisation), end follow-up (week 17 or 18 depending on randomisation)
Secondary outcome [6] 432543 0
Cognitive flexibility
Timepoint [6] 432543 0
Study inception (week 0), end baseline (week 3 or 4 depending on randomisation), end intervention (week 11 or 12 depending on randomisation), end follow-up (week 17 or 18 depending on randomisation)

Eligibility
Key inclusion criteria
Stroke survivors: aged over 18-years of age, living in the community, with self-reported post-stroke fatigue.
Caregivers: Where stroke survivors report living with a caregiver, they will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are unable to actively and effectively participate in the intervention. People who are non-English speaking and cannot be accommodated through interpreting services who can support their participation, or people who have cognitive impairment that limits participation in the online intervention will be excluded from this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
A single case experimental design (SCED: A-B-A1 phases) with multiple baselines.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
23/12/2024
Actual
Date of last data collection
Anticipated
28/04/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316018 0
Charities/Societies/Foundations
Name [1] 316018 0
Stroke Foundation
Country [1] 316018 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 318170 0
None
Name [1] 318170 0
None
Address [1] 318170 0
Country [1] 318170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314841 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 314841 0
Ethics committee country [1] 314841 0
Australia
Date submitted for ethics approval [1] 314841 0
07/03/2024
Approval date [1] 314841 0
22/05/2024
Ethics approval number [1] 314841 0

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

Contacts
Principal investigator
Name 132894 0
Dr Dawn Simpson
Address 132894 0
The University of Newcastle ICT Building University Drive, Callaghan NSW 2308
Country 132894 0
Australia
Phone 132894 0
+61 02 4042 0822
Fax 132894 0
Email 132894 0
dawn.simpson@newcastle.edu.au
Contact person for public queries
Name 132895 0
Dawn Simpson
Address 132895 0
The University of Newcastle ICT Building University Drive, Callaghan NSW 2308
Country 132895 0
Australia
Phone 132895 0
+61 02 4042 0822
Fax 132895 0
Email 132895 0
dawn.simpson@newcastle.edu.au
Contact person for scientific queries
Name 132896 0
Dawn Simpson
Address 132896 0
The University of Newcastle ICT Building University Drive, Callaghan NSW 2308
Country 132896 0
Australia
Phone 132896 0
+61 02 4042 0822
Fax 132896 0
Email 132896 0
dawn.simpson@newcastle.edu.au

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?

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.