ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Fatigue

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

Rehabilitation

Intervention code [2]

Behaviour

Intervention code [3]

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]

Fatigue

Timepoint [1]

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]

Fatigue

Timepoint [1]