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Trial registered on ANZCTR


Registration number
ACTRN12607000268448
Ethics application status
Approved
Date submitted
4/05/2007
Date registered
18/05/2007
Date last updated
18/05/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an Online Fatigue Self-management Group Intervention for Adults with Chronic Neurological Conditions
Scientific title
Effectiveness of an online fatigue self-management program on well-being, fatigue and activity participation in adults with fatigue secondary to chronic neurological conditions in comparison with an online support group and a no intervention group
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue secondary to Multiple Sclerosis, Parkinson's disease (PD), Cerebral Palsy, chronic fatigue syndrome and Post-polio syndrome 1808 0
Condition category
Condition code
Neurological 1896 1896 0 0
Dementias
Neurological 1897 1897 0 0
Multiple sclerosis
Neurological 1898 1898 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Information Only Group: To exclude the possibility that "attention" accounts for improvement, this group of participants will receive information once per week via the Internet. They will be able to read the information about how to manage fatigue. The education information will be posted once per week. The length of this group will be 7 weeks.

Fatigue Management online intervention group: This 7-week intervention will follow the published protocol outlined in Managing fatigue (Packer et al., 1995). Each session is highly structured and includes an education session, practice activities, discussions and homework assignment. All teaching content, worksheets, and homework assignments are provided online. Based on self-efficacy theory (Bandura, 1997) each session incorporates strategies known to increase confidence in the ability to engage in specific behaviours. Also participants can share information, express their ideas or feelings and offer advice or support to one another. The intervention will be run by facilitators who have been trained.
Intervention code [1] 1742 0
Rehabilitation
Comparator / control treatment
No Intervention (control) Group: Participants in this group will receive no intervention but will complete all the tests. Face to face interventions are offered as usual care in some locations for people with MS, however, participants in this study cannot travel/attend these sessions. Hence for this group no intervention is usual care. For those other than with MS, the usual care is no intervention.
Control group
Active

Outcomes
Primary outcome [1] 2695 0
The Fatigue Impact Scale
Timepoint [1] 2695 0
At baseline, after completion of the intervention and 3 months later
Primary outcome [2] 2696 0
The Personal Wellbeing Index
Timepoint [2] 2696 0
At baseline, after completion of the intervention and 3 months later
Primary outcome [3] 2697 0
The Australian version of Activity Card
Timepoint [3] 2697 0
At baseline, after completion of the intervention and 3 months later
Secondary outcome [1] 4560 0
The Generalised self-efficacy scale
Timepoint [1] 4560 0
At baseline, after completion of the intervention and 3 months later
Secondary outcome [2] 4561 0
The 11-item Duke Social Support Index
Timepoint [2] 4561 0
At baseline, after completion of the intervention and 3 months later
Secondary outcome [3] 4562 0
The Depression Anxiety Stress Scale
Timepoint [3] 4562 0
At baseline, after completion of the intervention and 3 months later

Eligibility
Key inclusion criteria
Confirmed diagnosis of multiple sclerosis, cerebral palsy, Parkinson's disease, chronic fatigue syndrome or post-polio syndrome (letter from their physicians);Access to the internet three times per week for at least one hour;A Fatigue Severity Scale score of 4 or higher (i.e. moderate-to-high fatigue impact).
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous participation in 'Fatigue Management' face-to-face self-management group intervention; orPoor cognitive ability (Greater than 9 on the Memory Orientation Concentration Test

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be employed. Enrollment and pre-test data collection will occur prior to randomization. Central, block randomization will be done via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Restricted randomization using blocking. For each block the sequence will be done using a randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
blinding is not possible in education based interventions which require active participation of participants and therapists
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2042 0
University
Name [1] 2042 0
Curtin University
Country [1] 2042 0
Funding source category [2] 2043 0
Name [2] 2043 0
Lottery West
Country [2] 2043 0
Funding source category [3] 2044 0
Charities/Societies/Foundations
Name [3] 2044 0
MS Society WA
Country [3] 2044 0
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 1850 0
Charities/Societies/Foundations
Name [1] 1850 0
Multiple Sclerosis Society, Western Australia
Address [1] 1850 0
Country [1] 1850 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3779 0
Curtin University of Technology
Ethics committee address [1] 3779 0
Ethics committee country [1] 3779 0
Australia
Date submitted for ethics approval [1] 3779 0
Approval date [1] 3779 0
10/01/2006
Ethics approval number [1] 3779 0
OT-2005-14
Ethics committee name [2] 3780 0
Multiple Sclerosis Society of WA
Ethics committee address [2] 3780 0
Ethics committee country [2] 3780 0
Australia
Date submitted for ethics approval [2] 3780 0
Approval date [2] 3780 0
Ethics approval number [2] 3780 0

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

Contacts
Principal investigator
Name 27845 0
Address 27845 0
Country 27845 0
Phone 27845 0
Fax 27845 0
Email 27845 0
Contact person for public queries
Name 10931 0
Setareh Ghahari
Address 10931 0
Curtin Univeristy
Kent Street
GPO Box U1987
Perth WA 6845
Country 10931 0
Australia
Phone 10931 0
+61 8 92661790
Fax 10931 0
+61 8 92663636
Email 10931 0
ghahari.setareh@postgrad.curtin.edu.au
Contact person for scientific queries
Name 1859 0
Professor Tanya L. Packer
Address 1859 0
Curtin Univeristy
Kent Street
GPO Box U1987
Perth WA 6845
Country 1859 0
Australia
Phone 1859 0
+61 8 92663621
Fax 1859 0
+61 8 92663636
Email 1859 0
t.packer@curtin.edu.au

No information has been provided regarding IPD availability


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.