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Trial registered on ANZCTR


Registration number
ACTRN12611000790943
Ethics application status
Approved
Date submitted
27/07/2011
Date registered
28/07/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing fatigue after brain injury: a pilot study
Scientific title
The effect of education versus activity coaching on fatigue in adults post-traumatic brain injury (TBI) when compared to usual care: a pilot study
Secondary ID [1] 262723 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild or moderate traumatic brain injury 270429 0
Fatigue 270434 0
Condition category
Condition code
Neurological 270575 270575 0 0
Other neurological disorders
Injuries and Accidents 270576 270576 0 0
Other injuries and accidents
Alternative and Complementary Medicine 270577 270577 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 CBT based fatigue management education, one hour group based session held weekly for 6 weeks.

Arm 2 Activity coaching (an approach using techniques, such as motivational interviewing, problem identification, solution generation and goal setting, to increase motivation and identify activities that are meaningful and sustainable for the participant) one hour group based session held weekly for 6 weeks

Arm 3 Usual care
Intervention code [1] 267067 0
Rehabilitation
Intervention code [2] 267068 0
Behaviour
Comparator / control treatment
Treatment as usual - this is defined as receipt of medical and psychological treatment as provided by the service as part of standard care.
Control group
Active

Outcomes
Primary outcome [1] 269318 0
Fatigue as measured by fatigue severity scale
Timepoint [1] 269318 0
At baseline, 6 and 12 weeks
Primary outcome [2] 269319 0
Fatigue as measured by the Checklist of Individual Strength
Timepoint [2] 269319 0
At baseline, 6 and 12 weeks
Secondary outcome [1] 279364 0
Health related quality of life as assessed by the RAND Short form-36
Timepoint [1] 279364 0
At baseline, 6 and 12 weeks
Secondary outcome [2] 279365 0
Memory as assessed by the Cognitive failures questionnaire
Timepoint [2] 279365 0
At baseline, 6 and 12 weeks
Secondary outcome [3] 279366 0
Mood as assessed by the Hospital Anxiety and Depression Scale
Timepoint [3] 279366 0
At baseline, 6 and 12 weeks
Secondary outcome [4] 279367 0
Illness perceptions as assessed by the Brief Illness Perception Questionnaire
Timepoint [4] 279367 0
At baseline, 6 and 12 weeks
Secondary outcome [5] 279368 0
Level of Physical Activity as assessed by the Physical Activity and Disability Survey - Revised
Timepoint [5] 279368 0
At baseline, 6 and 12 weeks

Eligibility
Key inclusion criteria
3-12 months post- (mild or moderate) TBI
Experiencing moderate to severe fatigue as defined as a Fatigue Severity Scale score >3
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Significant impairments which preclude them from benefiting from the intervention;
2) Behaviour which would interfere with participation in a group setting;
3) Not fluent in English or have dysphasia;
4) They are medically unstable;
5) Participation in another study that may affect fatigue or add significantly to a participants burden;
6) Travel from their residence to the study centre for group meetings impacts fatigue to a level that precludes participation in group activities; or
7) Co-morbid condition that could impact results.

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)
Participants will be recruited via concussion clinics in the Auckland region of New Zealand (NZ). After confirming eligibility to participate in the study, participants will be randomised to one of the three treatment groups (CBT based fatigue management, activity coaching or usual care). Participants will be randomised centrally by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
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] 3757 0
New Zealand
State/province [1] 3757 0
Auckland

Funding & Sponsors
Funding source category [1] 267543 0
University
Name [1] 267543 0
Auckland University of Technology (AUT)
Address [1] 267543 0
AUT North Shore Campus
90 Akoranga Drive
Northcote, Auckland 0627
Country [1] 267543 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT)
Address
AUT North Shore Campus
90 Akoranga Drive
Northcote, Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 266580 0
None
Name [1] 266580 0
Address [1] 266580 0
Country [1] 266580 0
Other collaborator category [1] 252139 0
Commercial sector/Industry
Name [1] 252139 0
Integrated Partners in Health (IPH)
Address [1] 252139 0
29 Enfield Street,
Mount Eden, Auckland 1150
Country [1] 252139 0
New Zealand
Other collaborator category [2] 252140 0
Commercial sector/Industry
Name [2] 252140 0
ABI Rehabilitation New Zealand
Address [2] 252140 0
180 Metcalfe Rd
Ranui, Waitakere 0612
Country [2] 252140 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269499 0
Northern X Regional Ethics Committee
Ethics committee address [1] 269499 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Road, Penrose
Auckland 1061
Ethics committee country [1] 269499 0
New Zealand
Date submitted for ethics approval [1] 269499 0
15/11/2010
Approval date [1] 269499 0
14/02/2011
Ethics approval number [1] 269499 0
NTX/10/10/107

Summary
Brief summary
Fatigue is a common and persistent problem after brain injury. This study aims to look at whether group sessions focusing on increasing physical activity or fatigue management education can reduce levels of fatigue for people who have experienced a brain injury, in comparison to those receiving treatment as usual
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32941 0
Dr Alice Theadom
Address 32941 0
AR415, 90 Akoranga Drive,
Northcote
Auckland 0627
Country 32941 0
New Zealand
Phone 32941 0
+64 9 921 9999 x7805
Fax 32941 0
Email 32941 0
alice.theadom@aut.ac.nz
Contact person for public queries
Name 16188 0
Mr Rohit Bhattacharjee
Address 16188 0
AA254C, AUT North Shore Campus
90 Akoranga Drive
Northcote, Auckland 0627
Country 16188 0
New Zealand
Phone 16188 0
+64 9 921 9999 x7126
Fax 16188 0
+64 9 921 9620
Email 16188 0
rbhattac@aut.ac.nz
Contact person for scientific queries
Name 7116 0
Dr Alice Theadom
Address 7116 0
AR415, 90 Akoranga Drive,
Northcote
Auckland 0627
Country 7116 0
New Zealand
Phone 7116 0
+64 9 921 9999 x7805
Fax 7116 0
+64 9 921 9620
Email 7116 0
alice.theadom@aut.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary