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Trial registered on ANZCTR


Registration number
ACTRN12616000296437
Ethics application status
Approved
Date submitted
26/02/2016
Date registered
7/03/2016
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the efficacy of online continuing education for health professionals to improve the management of Chronic Fatigue Syndrome (CFS).
Scientific title
A randomised controlled trial of online continuing education for health professionals to improve the management of CFS.
Secondary ID [1] 288635 0
Nil known
Universal Trial Number (UTN)
UN1111-1180-1073
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue Syndrome 297802 0
Myalgic encephalomyelitis 297803 0
Condition category
Condition code
Other 297981 297981 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an eLearning program that will be accessed online for a duration of four weeks. The eLearning program contains an introduction to CFS and seven learning modules (1: Psychoeducation; 2. Activity pacing and graded exercise therapy; 3. Interventions for sleep-wake cycle disturbance; 4. Interventions of neurocognitive functioning in CFS; 5. Interventions for mood disturbance; 6. Interventions for anxiety; 7. Interventions for coping). Learning activities (e.g., concept maps, free text response questions, fill in the blanks) with feedback regarding responses are embedded within each module to facilitate learning. Each module take approximately 30- to 60-mins to complete. The program has been designed so participants can complete the modules within a time frame of their own choosing (e.g., over multiple sittings if they wish) and are able to revisit completed sections at will. The eLearning software will monitor adherence, time to complete, frequency of visits to the program and participant progress.
Intervention code [1] 294045 0
Treatment: Other
Comparator / control treatment
The control group will consist of health professionals that have been randomly allocated to the waiting list and do not have access to the intervention (i.e., eLearning program). They will receive access to the intervention after post-intervention data has been collected, that is, 4 weeks after the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 297502 0
Participants’ knowledge about CFS and CFS interventions measured at post intervention compared with baseline. Multiple choice and short answer questions, integrated with case vignettes, will test participants’ knowledge about CFS symptoms, differential diagnosis, CFS management strategies and interventions (CBT and GET), and interventions for conditions that commonly arise secondary to fatigue (reduced mood and anxiety).
Timepoint [1] 297502 0
Primary outcome data will be collected at three time points. Both groups will complete the outcome measure at baseline (week 0) and post-intervention (week 4-5), while the follow-up measures will be completed in week 12 for the education group and week 16 for the wait-list control group.
Primary outcome [2] 299384 0
Participants’ self-reported confidence in their knowledge of CFS and confidence in their clinical skills to implement evidence-based CFS interventions. This part of the questionnaire requires participants to rate their confidence in their knowledge and clinical skills related to CFS using a 5-point Likert scale anchored at one end with “not at all confident” and at the other end with “very confident”.
Timepoint [2] 299384 0
Data will be collected at three time points. Both groups will complete the outcome measures at baseline (week 0) and post-intervention (week 4-5), while the follow-up measures will be completed in week 12 for the education group and week 16 for the wait-list control group.
Primary outcome [3] 299385 0
Participants’ self-reported success in treating people with CFS or medically unexplained fatigue. This part of the questionnaire requires participants to rate their level of success in treating people with CFS or medically unexplained fatigue using a 5-point Likert scale, anchored at one end with “completely unsuccessful” and at the other end with “completely successful”.
Timepoint [3] 299385 0
Data collected at the at the 8- week follow-up, i.e., week 12 for the education group and week 16 for the wait list control group.
Secondary outcome [1] 326998 0
Data on adherence to and satisfaction with the education activity will be collected for the education group only. Intervention adherence will be tracked using in-built features of the online education platform, which will monitor: time spent in total on the activity, time spent on each module of the activity and engagement in integrated formative assessment tasks. Participants will be asked to rate their agreement with a number of statements related to their satisfaction with the online education activity. This will be done using a 5-point Likert scale anchored at one end with “strongly disagree” and at the other end with “strongly agree”. Open-ended responses will also be collected.
Timepoint [1] 326998 0
Data will be collected after completing the intervention at weeks 4-5 in the Education group only.
Secondary outcome [2] 326999 0
Participants self-reported portion of clinical practice devoted to people with CFS or medically unexplained fatigue. This part of the questionnaire requires the participant to indicate the percentage of their clinical practice that is devoted to people with CFS or medically unexplained fatigue.
Timepoint [2] 326999 0
Data collected at the at the 8- week follow-up, i.e., week 12 for the education group and week 16 for the wait list control group.
Secondary outcome [3] 327000 0
The secondary outcome measure will be the retention of knowledge about CFS and CFS interventions at follow-up, and participants’ self-reported confidence in their clinical skills, at follow-up. As with the primary outcome measures, multiple choice and short answer questions, integrated with case vignettes, will test participants’ knowledge about CFS symptoms, differential diagnosis, CFS management strategies and interventions (CBT and GET), and interventions for conditions that commonly arise secondary to fatigue (reduced mood and anxiety). Similarly, participants’ self-reported confidence in their knowledge of CFS and confidence in their clinical skills to implement evidence-based CFS interventions will be assessed by a questionnaire requiring them to rate their confidence in their knowledge and clinical skills related to CFS using a 5-point Likert scale anchored at one end with “not at all confident” and at the other end with “very confident”.
Timepoint [3] 327000 0
Data collected at the at the 8- week follow-up, i.e., week 12 for the education group and week 16 for the wait list control group.

Eligibility
Key inclusion criteria
Fully registered member of relevant allied health professional body (e.g., Australian Psychological Society, Exercise and Sports Science Association), currently practicing.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Studying to be a health professional but without having completed the relevant degree.

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 recruited through advertisements placed in e-bulletins released by relevant professional associations. A technical support officer will program the eLearning platform to automatically deliver the intervention at week0 (the intervention group) or at week12 (wait list control group) depending on group allocation. The experimenters will not be aware of when individual participants receive the intervention ensuring allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated using an electronically generated number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
A total sample of 128 participants is required to detect a moderate effect size of improvement in clinician knowledge and confidence, with a power of 80% and a 2-tailed alpha of 0.05. However, 180 participants will be recruited to account for a potential 30% attrition rate.

Change scores (from Baseline to post-intervention) of the knowledge assessment and self-reported confidence for the intervention and control group will be compared using t-tests to determine improved CFS knowledge/skills. Self reported success in treating people and portion of clinical practice devoted to people with CFS will be compared at baseline and follow-up using t-tests.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292993 0
Charities/Societies/Foundations
Name [1] 292993 0
The Judith Jan Mason & Harold Stannett Williams Memorial Foundation
Address [1] 292993 0
4/100 Queen Street
Melbourne VICTORIA 3000
Country [1] 292993 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Australia
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 291767 0
None
Name [1] 291767 0
Address [1] 291767 0
Country [1] 291767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294501 0
UNSW Human research ethics committee
Ethics committee address [1] 294501 0
Ethics committee country [1] 294501 0
Date submitted for ethics approval [1] 294501 0
04/04/2016
Approval date [1] 294501 0
06/07/2016
Ethics approval number [1] 294501 0
HC16419

Summary
Brief summary
Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2-2.6% of the world’s population (Prins et al, 2006). There is Level One evidence indicating that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) is currently the most effective means to manage CFS (for review see Larun et al, 2015; Prince et al, 2008). Despite GET and CBT being widely acknowledged as best-practice interventions for CFS, the great majority of patients in Australia are not receiving these appropriate evidence-based interventions. Recent studies have demonstrated that the reason for this documented gap between research and practice is largely due to practicing health professionals lacking the knowledge and skills to provide appropriate care.
In order to address this lack of knowledge, our group has developed a CFS Treatment Manual and accompanying DVD aimed at providing clinicians with the knowledge and skills required to effectively manage CFS. However, recent studies have documented that seeking to train clinicians simply by providing a manual is ineffective (Wiborg et al, 2014). Other barriers to continuing education of practicing clinicians include the financial expense of courses and the geographical constraints of attending training (McHugh & Barlow, 2010). The proposed study aims to conduct a randomised controlled trial (RCT) to evaluate the efficacy of the eLearning activity in improving clinician knowledge of CFS and their confidence and skills in implementing evidence-based CFS interventions.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63946 0
Dr Sophie Huk Lahn Li
Address 63946 0
UNSW Australia
High Street
Kensington, NSW, 2052
Country 63946 0
Australia
Phone 63946 0
+61 (2) 9385 8657
Fax 63946 0
Email 63946 0
s.h.li@unsw.edu.au
Contact person for public queries
Name 63947 0
Dr Sophie Huk Lahn Li
Address 63947 0
UNSW Australia
High Street
Kensington, NSW, 2052
Country 63947 0
Australia
Phone 63947 0
+61 (2) 9385 8709
Fax 63947 0
Email 63947 0
s.h.li@unsw.edu.au
Contact person for scientific queries
Name 63948 0
Dr Sophie Huk Lahn Li
Address 63948 0
UNSW Australia
High Street
Kensington, NSW, 2052
Country 63948 0
Australia
Phone 63948 0
+61 (2) 9385 8709
Fax 63948 0
Email 63948 0
s.h.li@unsw.edu.au

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