Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000553370
Ethics application status
Approved
Date submitted
16/09/2008
Date registered
3/11/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an Online Fatigue Self-management Group Intervention for Adults with Multiple Sclerosis
Scientific title
Effectiveness of an online fatigue self-management program on quality of life, fatigue and activity participation in adults with fatigue secondary to multiple sclerosis in comparison with a face-to-face 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 3705 0
Condition category
Condition code
Neurological 3870 3870 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fatigue Management online intervention group: This 7-week intervention will follow the published protocol outlined in Managing fatigue (Packer et al., 1995). Full participation requires 2 hours per week of online contribution. Each session is highly structured and includes an education session, practice activities, discussions and homework assignment. The topics include the importance of rest, communication and body mechanics , organizing work stations, setting priorities and standards, balancing schedules and setting goals. All teaching content, worksheets, and homework assignments are provided online. 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] 3417 0
Rehabilitation
Comparator / control treatment
Control group 1: No Intervention (control) Group: Participants in this group will receive only the routine care provided for people with multiple sclerosis ranging from nothing to specialist care and/or community care. The participants in this group will complete the pre, post and follow up tests.

Control group 2: Face-to-face intervention group: The intervention will follow the published protocol outlined in Managing fatigue (T. Packer et al., 1995) including one 2-hour session weekly for 6 weeks. Each session is highly structured and includes an education session, practice activities, discussions and homework assignment. All teaching content, worksheets, handouts and homework assignments are standardized and provided. Based on self-efficacy theory (Bandura, 1997) each session incorporates strategies known to increase confidence in the ability to engage in specific behaviours. Each face-to-face course will be taught at a community setting easily accessible to group participants. Face-to-face programs will be offered at a minimum of 3 States through the Multiple Sclerosis Society of that State. Facilitators administering the interventions will be qualified health professionals (occupational therapists, nurses or social workers) who have completed a 2-day training course.
Control group
Active

Outcomes
Primary outcome [1] 4773 0
Primary Outcome 1: Fatigue impact on persons' life measured by the Modified Fatigue Impact Scale
Timepoint [1] 4773 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Primary outcome [2] 4774 0
Primary Outcome 2: Quality of life measured by the Leeds Multiple Sclerosis Quality of Life Scale
Timepoint [2] 4774 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Primary outcome [3] 4775 0
Primary Outcome 3: Activity Participantion measured by the Australian version of Activity Card Sort
Timepoint [3] 4775 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Secondary outcome [1] 8064 0
Secondary Outcome 1: Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 8064 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Secondary outcome [2] 8065 0
Secondary Outcome 2: Disease progression measured by the Patient Determined Disease Steps
Timepoint [2] 8065 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Secondary outcome [3] 8066 0
Secondary Outcome 3: Multiple sclerosis-associated disability measured by the Performance Scales
Timepoint [3] 8066 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Secondary outcome [4] 8067 0
Secondary Outcome 4: Social support measured by the Duke Social Support Index
Timepoint [4] 8067 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Secondary outcome [5] 8068 0
Secondary Outcome 5: Self-efficacy measured by the Multiple Sclerosis Self-Efficacy
Timepoint [5] 8068 0
Timepoints: At baseline, after completion of the intervention and 3 months later
Secondary outcome [6] 8069 0
Secondary Outcome 6: Depression, anxiety and stress measured by the Depression Anxiety Stress Scale - short form
Timepoint [6] 8069 0
Timepoints: At baseline, after completion of the intervention and 3 months later

Eligibility
Key inclusion criteria
Diagnosis of multiple sclerosis;
Aged 20 or older at time of selection;
A Fatigue Severity Scale (Dittner, Wessely, & Brown, 2004) 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 a 'Fatigue Management' face-to-face or an online self-management group intervention.

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)
Participants will be enrolled once time one questionnaires were completed and then allocated to group. Allocation will be concealed by central randomization of participants by sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using sealed envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The online program has originally been developed to provide service to the group of people who live in rural and remote areas and have no access to the face-to-face programs. Therefore a two stage allocation process will be required. On enrolment, participants with access to transportation (i.e. they can be present in community setting either by themselves or by somebody else’s help one day a week for 6 weeks) will participate in face-to-face intervention. All the others will be randomly allocated to one of the two groups (an online fatigue self-management program or a no intervention group) through randomization using sealed envelopes.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3883 0
Government body
Name [1] 3883 0
Multiple Sclerosis Research Australia
Country [1] 3883 0
Australia
Funding source category [2] 3885 0
Charities/Societies/Foundations
Name [2] 3885 0
Multiple Sclerosis Society of WA (Inc)
Country [2] 3885 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
School of Occupational Therapy and Social Work, GPO Box U1987, WA 6845
Country
Australia
Secondary sponsor category [1] 3487 0
None
Name [1] 3487 0
Address [1] 3487 0
Country [1] 3487 0
Secondary sponsor category [2] 3568 0
None
Name [2] 3568 0
Address [2] 3568 0
Country [2] 3568 0
Other collaborator category [1] 415 0
Charities/Societies/Foundations
Name [1] 415 0
MS Society of Victoria
Address [1] 415 0
391 Hagreaves Street, Bendigo VIC 3550
Country [1] 415 0
Australia
Other collaborator category [2] 416 0
Charities/Societies/Foundations
Name [2] 416 0
MS Society of South Australia & Northern Territory
Address [2] 416 0
274 North East Road, Klemzig, SA 5087
Country [2] 416 0
Australia
Other collaborator category [3] 417 0
Charities/Societies/Foundations
Name [3] 417 0
MS Society of Queensland
Address [3] 417 0
286 Gladstone Road Dutton Park QLD 4102
Country [3] 417 0
Australia
Other collaborator category [4] 418 0
Charities/Societies/Foundations
Name [4] 418 0
MS Society of New Soth Wales
Address [4] 418 0
Studdy MS Centre, Joseph Street Lidcombe NSW, 2141
Country [4] 418 0
Australia
Other collaborator category [5] 419 0
Charities/Societies/Foundations
Name [5] 419 0
MS Society of Australian Capital Territory
Address [5] 419 0
Gloria McKerrow House, 117 Denison Street, Deakin, ACT 2600
Country [5] 419 0
Australia
Other collaborator category [6] 420 0
Charities/Societies/Foundations
Name [6] 420 0
MS Society of Tasmania
Address [6] 420 0
Locked Bag 4, Sandy Bay, Tas 7005
Country [6] 420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5934 0
Curtin University Human research Ethics
Ethics committee address [1] 5934 0
Ethics committee country [1] 5934 0
Australia
Date submitted for ethics approval [1] 5934 0
Approval date [1] 5934 0
02/09/2008
Ethics approval number [1] 5934 0
HR 114/2008

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

Contacts
Principal investigator
Name 28942 0
Address 28942 0
Country 28942 0
Phone 28942 0
Fax 28942 0
Email 28942 0
Contact person for public queries
Name 12099 0
Ms. Setareh Ghahari
Address 12099 0
School of Occupational Therapy, Curtin University of Technology, GPO Box U1987, WA 6845
Country 12099 0
Australia
Phone 12099 0
+61 8 9266 1790
Fax 12099 0
+61 8 9266 3636
Email 12099 0
[email protected]
Contact person for scientific queries
Name 3027 0
Prof. Tanya L. Packer
Address 3027 0
School of Occupational Therapy, Curtin University of Technology, GPO Box U1987, WA 6845
Country 3027 0
Australia
Phone 3027 0
+61 8 9266 3621
Fax 3027 0
+61 8 9266 3636
Email 3027 0
[email protected]

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.