Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001056987
Ethics application status
Approved
Date submitted
25/05/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Date results information initially provided
16/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Recognising and managing fatigue after brain injury
Scientific title
'Evaluation of a targeted fatigue management program for adult patients with an Acquired Brain Injury'
Secondary ID [1] 301167 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 317292 0
Fatigue 317293 0
Condition category
Condition code
Neurological 315413 315413 0 0
Other neurological disorders
Injuries and Accidents 315414 315414 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those participants allocated to the Fatigue Management Group attended 60 minute sessions twice a week for two weeks until the four modules have been completed. The Fatigue Management Group was set up with the purpose of educating clients about the common effects of fatigue after brain injury. The group was divided into four separate modules, Module 1: What is fatigue? Module 2: Recognising signs of fatigue, Module 3: Understanding your fatigue and Module 4: Healthy living and fatigue. Participants were encouraged to keep a fatigue log to better understand their individual patterns of fatigue and this log was reviewed by the therapist at each session. The group was run by an experienced Occupational Therapist. Those patients allocated to the group did not receive additional fatigue management rehabilitation within their 1 to 1 OT sessions.
Intervention code [1] 317473 0
Rehabilitation
Comparator / control treatment
The participants allocated to the Usual Care Group received therapy from their occupational therapist in one to one sessions in a non protocolised manner but generally included
• One 60 minute session discussing fatigue, and clarifying that it is a common symptom following an ABI.
• Supporting the patient to formulate rehabilitation goals that addressed engagement affected by fatigue at discharge from the inpatient program as well as when planning weekend rehabilitation leave.
• Some therapists encouraged their patient to keep a fatigue log, and reviewed the log with the patient on a weekly basis, but this was not routinely done.
Control group
Active

Outcomes
Primary outcome [1] 323664 0
The Quality of Life After Brain Injury questionnaire (QOLIBRI) is a health related quality of life measure specifically developed to be used by people with brain injury (von Steinbuchel et al., 2010). This comprehensive questionnaire has 37 items covering six dimensions of QOL after brain injury and seeks a person’s perspective on their health condition, functioning and well being in relation to their physical, psychological, social and daily life. The scores are converted to a 0-100 scale where 0 represents the worse possible quality of life and a maximum value of 100 the best possible quality of life.
Timepoint [1] 323664 0
baseline and 2 weeks post enrolment
Primary outcome [2] 323665 0
The Barrow Neurological Institute Fatigue Scale (BNI-FS) is a self-reported questionnaire developed to assess fatigue associated with acquired brain injury during the early stages of recovery. Scores range from 0 (no problem) to 80 (severe problem). The BNI-FS is highly correlated to other tools which measure fatigue and therefore supports the convergent and discriminant validity. The internal consistency reliability for the BNI-FS was shown to be very high , with a Cronbach’s alpha (a) of 0.96 (Waljas et al., 2012).
Timepoint [2] 323665 0
baseline and 2 weeks post enrolment
Primary outcome [3] 323666 0
The Fatigue Knowledge questionnaire to investigate participants’ knowledge and understanding of brain injury related fatigue was developed by the research team and collected information directly related to the aims of the education modules. It was important to investigate whether there were any differences in knowledge acquisition and attitudes to fatigue management between the two groups. Scores ranged from 0 (poor acquisition of knowledge) to 28 (good acquisition of knowledge).
Timepoint [3] 323666 0
baseline and 2 weeks post enrolment
Secondary outcome [1] 382524 0
Perceptions of participants who completed the intervention. Interested participants who attended the intervention were sought from 26/08/2016 until 10 people had consented to attend an interview to share their perceptions regarding their experience of managing fatigue and any benefits or limitations of the group based intervention.
Timepoint [1] 382524 0
within 12 months of baseline

Eligibility
Key inclusion criteria
Inpatient of brain injury rehabilitation unit.
Reported problematic fatigue symptoms.
Cognitive ability and behaviors to cope with education modules in a group learning environment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No problematic fatigue symptoms.
Cognitive or behavioral dysfunction that prevented them from coping with education modules in a group learning environment

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)
A computer generated random sequence with random block sizes was used by a person external to the project to allocate people to 1. Usual care where patients received education and support to manage their fatigue symptoms as a component of their overall inpatient rehabilitation. 2. Attend Fatigue Management Group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random sequence with random block sizes was used by a person external to the project.
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
1. A two factor General Linear Model was used to investigate changes in fatigue, quality of life and knowledge about how fatigue affects a person following an ABI with time (pre-post) and condition (usual care/group education) as factors. Alpha was defined at 0.05.
2. Qualitative data: Data was analysed thematically using nVivo11 software (QSR International Pty Ltd. Version 11, 2015).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/08/2014
Date of last participant enrolment
Anticipated
Actual
5/10/2016
Date of last data collection
Anticipated
Actual
21/10/2016
Sample size
Target
70
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16591 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 30180 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 305611 0
Government body
Name [1] 305611 0
Lifetime Support Authority
Country [1] 305611 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Rm 214, Ground Floor, Rehabilitation Building 12
Repatriation Health Precinct
216 Daws Road, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 306023 0
None
Name [1] 306023 0
Address [1] 306023 0
Country [1] 306023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305907 0
Central Adelaide Local Health Network
Ethics committee address [1] 305907 0
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305907 0
Australia
Date submitted for ethics approval [1] 305907 0
26/06/2014
Approval date [1] 305907 0
04/07/2014
Ethics approval number [1] 305907 0
HREC/14/RAH/198

Summary
Brief summary
A mixed methods study. A randomised controlled trial with 78 participants adult inpatients with severe acquired brain injury; 40 allocated to routine usual care and 38 to four group therapy sessions over two weeks run by an experienced Occupational Therapist. Outcome measures were collected at baseline and at the completion of the therapy (Barrow Neurological Institute Fatigue Scale, Quality of Life after Brain Injury questionnaire and a Fatigue Knowledge questionnaire assessing knowledge related to the aims of the education modules). Ten patients were interviewed to discuss their fatigue journey and impressions of receiving fatigue management therapy in a group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102018 0
Dr Maggie Killington
Address 102018 0
South Australia Brain Injury Rehabilitation Services
Royal Adelaide Hospital
Rm 214, Ground Floor, Rehabilitation Building 12
Repatriation Health Precinct
216 Daws Road, Daw Park South Australia 5041
Country 102018 0
Australia
Phone 102018 0
+61 400061204
Fax 102018 0
Email 102018 0
[email protected]
Contact person for public queries
Name 102019 0
Dr Maggie Killington
Address 102019 0
South Australia Brain Injury Rehabilitation Services
Royal Adelaide Hospital
Rm 214, Ground Floor, Rehabilitation Building 12
Repatriation Health Precinct
216 Daws Road, Daw Park South Australia 5041
Country 102019 0
Australia
Phone 102019 0
+61 400061204
Fax 102019 0
Email 102019 0
[email protected]
Contact person for scientific queries
Name 102020 0
Dr Maggie Killington
Address 102020 0
South Australia Brain Injury Rehabilitation Services
Royal Adelaide Hospital
Rm 214, Ground Floor, Rehabilitation Building 12
Repatriation Health Precinct
216 Daws Road, Daw Park South Australia 5041
Country 102020 0
Australia
Phone 102020 0
+61 400061204
Fax 102020 0
Email 102020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Quantitative outcome measures
When will data be available (start and end dates)?
From May 2020, no end date determined
Available to whom?
researchers for meta-analyses
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
request through email to

Dr Maggie Killington
[email protected]


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.