Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000826741
Ethics application status
Approved
Date submitted
2/05/2022
Date registered
10/06/2022
Date last updated
25/01/2024
Date data sharing statement initially provided
10/06/2022
Date results information initially provided
25/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Multiple Sclerosis (MS) WorkSmart Feasibility Study
Scientific title
A pragmatic randomised controlled feasibility study of MS WorkSmart: an online intervention for Australians with MS who are employed.
Secondary ID [1] 306824 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 325907 0
Condition category
Condition code
Neurological 323219 323219 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those in the intervention group receive the MS WorkSmart intervention package, which includes access to the MS WorkSmart Program, the My SymptoMS App, Support via zoom, and a closed Facebook group. The total duration of the intervention is 10 weeks.

MS WorkSmart Program
Those randomised to the MS WorkSmart intervention package will be emailed with a link to access the MS WorkSmart website. The MS WorkSmart Program consists of 9 modules. Participants will be asked to complete one module per week, with a week’s break after module 5. The modules take about 1-1.5 hrs and the tasks 0.5 to 1 hour. MS WorkSmart has been specifically designed for people with MS.

Overview MS WorkSmart intervention

Module 1 Your Work Introduction module that discusses barriers in employment, the factors that might impact on employment and quality of life more broadly. It allows the participant to gain insights into their MS, including symptoms, clinical care team, and medications, as well as their employment, including the type of work, working hours, barriers in their workplace, reasons of working, the implications of not working, and work satisfaction.
Module 2 Your Symptoms This module enables participants to gain insights into the symptoms that are most impacting on their work. It introduces a six-step plan of symptom management, including prevention through planning and boundaries, understanding patterns in symptoms and factors, looking for signs that something may be amiss, recognising when symptoms are present or are worsening, acting to try to improve those symptoms, and planning for a recovery when a break is needed.
Module 3 Smart Talk This module is about effective communication, the importance of it and the aspects that influence effective communication. The participants will gain insights into how to approach communicating their MS and will be provided with a series of questions to use for planning important conversations.
Module 4 Disclosure This module is about how to disclose MS to an employer, colleagues, friends, and family. Participants learn that disclosure is not a one-off scenario but is an ongoing process. They are encouraged to consider the reason for disclosing (or not), whether it is safe to disclose, how much to disclose, how to disclose, and when to disclose. Participants will be able to put their newly gained communication skills into action.
Module 5 Smart Facts This module is about the importance of knowing and communicating facts. Knowing and understanding facts about oneself, including one’s MS and personality traits around self-care, can spur participants into action. It also aims to deepen participants’ knowledge about using facts to communicate their needs in the workplace.
Module 6 Transforming Thoughts This module aims to create a shift in thinking about challenges in the workplace and life with MS in general. It explains how thoughts can impact on actions. Participants will identify thoughts that may result in unpreferred outcomes and how to go about changing those.
Module 7 Mindful living This module supports participants to identify stressors in their workplace and life more broadly, and suggests ways to reduce the impact of these stressors.
Module 8 Smart Work This module is about understanding what participants can do to change their workplace including the physical aspects as well as individual work practices and circumstances.
Module 9 Your Future This module focuses on planning for the future: how to implement the learnings of MS WorkSmart in the short and longer term; how to prevent falling back into ‘old habits’, and; how to plan for a future that is uncertain.

The intervention uses a mixture of videos, text, images, quotes, tips, quizzes and tasks to engage the participant, to allow participants to reflect upon their personal scenario, to learn from peers and experts, and to assist participants with implementing the learnings into practice. It has a dashboard that saves personal information (quizzes, tasks, and journal) and it provides access to the resources. Participants can pin useful resources on their dashboard as a favourite as they go through the modules. The dashboard will remind participants if there are quizzes or tasks that have not yet been completed.

Every module has a number of tasks where participants can apply any new knowledge to their personal scenario. The tasks will: give participants a deeper understanding of their personal circumstances; allow them to practice specific skills covered in the modules; assist them to consider what to change in the workplace or personal life, and; assist them with the preparation of specific changes. One example is to describe what they find rewarding about their work and what is coming in between them and their work goals. Another example is to plan for a conversation where they need to disclose their MS or explain some of their symptoms. They plan this by answering some of the questions covered in the module: Why am I giving this information?; Which information is necessary to give?; What outcome am I hoping for?; How do I think the receiver will respond?; What do I expect the receiver to do with the information?; What other factors that I need to take in to consideration?; What is the best way to communicate this?, and; When is the best way to communicate this?.

My SymptoMS App
To assist participants in identifying patterns in their symptoms and identifying whether behaviours, management strategies or medications have an impact on their symptoms, a companion App has been developed. This App aims to reduce the reliance on health professional assistance. It has been specifically designed for smartphones but is also accessible on ipads and computers.
Within MS WorkSmart, participants will be encouraged to choose to track the symptoms that have the highest impact on their work or the symptoms they feel they can manage better. Next, the participants will be asked to identify and track new behaviours that may influence the symptoms they wish to track. The visualisation within the App will provide feedback how they are tracking over time. Participants will be asked to use the App daily, i.e. one entry a day. Tasks specifically related to the My SymptoMS App are included in module 2, 5 and 7.

Support
Support will be provided by MS WorkSmart coaches. For the feasibility study, the coaches will be registered or provisionally registered psychologists with experience in delivering cognitive behaviour therapy and trained in occupational aspects for MS. A clinical psychologist will oversee the development of a training manual. It is intended that the final intervention (once fully implemented at the conclusion of this feasibility study) can also be delivered by an occupational therapist or other health professional with relevant expertise and training in MS WorkSmart protocols.
Each participant will receive a phone/zoom call from a coach after module 1, 3, 5, 7 and 9. The purpose of the telephone/zoom support is to address any issues the participant might have had with the module and the tasks, to discuss issues most important to them and to provide support for participants to implement changes in the workplace setting, which will increase motivation and engagement. They will also discuss how the participants are going with the My SymptoMS App. The calls are anticipated to last between 10 and 45 minutes. The feasibility study will identify whether the support can be reduced or tailored better to participant needs.
The intervention may empower participants to discuss work-related issues with their employer or have workplace assessments conducted. Ms Shapland (General Manager and MS Credentialed Nurse, MS Society Western Australia) will assist with referrals to local experts.

Closed Facebook group
We will set up a closed Facebook group where participants can communicate with fellow participants who also complete MS WorkSmart. The Support Team will post questions to which participants can respond, about one post per module. Examples include: “What works well for you in relation to managing your symptoms?”; “Are you able to share a positive experience where you communicated something important about your MS in the workplace? Why was the experience positive? What did you do well and what was the response?”. Participation in this component will be optional.

Usual care
Usual care will vary from not having any intervention/information/contact with a health professional, to having or having had discussions with an occupational therapist/employment services, or visiting a psychologist. We will ask participants to log any additional symptom management and vocational rehabilitation interventions they receive.

Intervention adherence and fidelity measures
We will capture information that will allow us to estimate participate adherence and dosage:
• The coaches will record information in the MS WorkSmart REDCap database: modules completed, phone/zoom support sessions completed (date calls due, date actual calls) and supports provided (tick from list with type of supports; free text fields for detail).
• Data collected as part of the MS WorkSmart Program has data on the completion of each quiz and task.
• The My SymptoMS data provides data on the engagement with symptom tracking and behaviour modification.

In terms of fidelity, all phone/zoom calls will be recorded, and an independent rater will conduct fidelity checks on 20% of calls to rate treatment adherence, integrity and fidelity to ensure the coaches are implementing the intervention as intended (i.e. dose delivered, dose received, and fidelity). Coach adherence criteria for each session will be checked in supervision meetings and the coaches will be provided with immediate and ongoing feedback.
Intervention code [1] 323288 0
Behaviour
Intervention code [2] 323670 0
Treatment: Other
Comparator / control treatment
Control participants will receive usual care only. We have chosen usual care because we wish to evaluate the real-world effectiveness of MS WorkSmart in a pragmatic trial rather than testing whether it works under an optimal situation (explanatory trial). With psychological interventions, clinical attention is an integral component of the intervention rather than a rival explanation. In our setting, usual care will vary from not having any intervention/information/contact with a health professional, to having or having had discussions with an occupational therapist/employment services, or visiting a psychologist. There are no readily available treatments available for symptom management in the workplace. We will ask participants to log any additional symptom management and vocational rehabilitation interventions they receive.
Control group
Active

Outcomes
Primary outcome [1] 331494 0
Recruitment rate is assessed as the percentage of eligible people interested in participating, using a recruitment survey, with participants indicating whether they are interested in participating and if not, the reason for not interested in participating.
Timepoint [1] 331494 0
After the recruitment has been completed.
Primary outcome [2] 331495 0
Drop out rates:
- The MS WorkSmart Program drop-out rate is assessed as the percentage of people randomised to the MS WorkSmart arm who complete more than 60% of the material, quizzes and tasks. This excludes participants who were prevented of completing the program due to a serious and lasting adverse event unrelated to the intervention. The data is collected using the data analytics from the online program.
- The study drop-out rate is assessed as the percentage of participants who complete both the baseline and post program survey. This will be estimated separately for the intervention and control group.
Timepoint [2] 331495 0
Upon completion of the study
Primary outcome [3] 331496 0
Number of MS WorkSmart Program modules and tasks completed by accessing website analytics and coach data.

Timepoint [3] 331496 0
Upon completion of the study
Secondary outcome [1] 408307 0
Obtain feedback on the MS WorkSmart intervention (MS WorkSmart Program: content, format, usefulness and duration; My SymptoMS App; coaching sessions; closed Facebook group), rating of the importance of varying outcome measures, and the need for a booster session 3 months after the intervention. This will be assessed via an online survey that was designed specifically for this study.
Timepoint [1] 408307 0
1 month post intervention completion
Secondary outcome [2] 408312 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

1. Change in work productivity loss – measured by the Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS)

Timepoint [2] 408312 0
Baseline and 1 month post intervention completion
Secondary outcome [3] 410470 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

2 Change in risk of job loss – The MS-WIS (22 Yes/No questions) captures the key aspects that we are targeting with MS WorkSmart including: 1) the physical and cognitive aspects of MS and their impact on work; 2) the working environment/organisational aspects; 3) social aspects of the working environment, and; 4) psychological aspects of working.
Timepoint [3] 410470 0
Baseline and 1 month post intervention completion
Secondary outcome [4] 410471 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

3. Change MS Work Behaviour Self-Efficacy Scale - This scale assesses self-efficacy around MS and employment, including symptom management, communicating about MS, arranging workplace adjustments and accommodations, reducing negative cognitions, and stress reduction and self-care activities. It has with 31 items, which are rated on a 6-point Likert-type scale (1 = strongly disagree, 6 = strongly agree). This is a newly developed scale and will be validated against the more generic Work Self-Efficacy Scale, an 8-item scale which assesses beliefs in ability to manage daily work tasks.

Timepoint [4] 410471 0
Baseline and 1 month post intervention completion
Secondary outcome [5] 410472 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

4. Change in EQ-5D-5L-Psychosocial - We will use the EQ-5D-5L-Psychosocial to assess health-related quality of life as this can be used to estimate utility scores for the cost-effectiveness evaluation of the fully powered trial. The EQ-5D-5L-Psychosocial includes the five EQ-5D5L items on mobility, self-care, usual activities, pain/discomfort and anxiety/depression with four additional items from the Assessment of Quality of Life (AQoL) scale (sleep, energy, close relationships, social isolation).

Timepoint [5] 410472 0
Baseline and 1 month post intervention completion
Secondary outcome [6] 410473 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

5. Change in symptom severity that impact work - The impact of key symptoms on work will be assessed on a 0-10 rating scale (including fatigue, pain, cognitive symptoms, walking difficulties, feelings of depression, feelings of anxiety, bladder problems, bowel problems, sensory symptoms, spasticity, vision, and an option to record other symptoms that have an impact on work).

Timepoint [6] 410473 0
Baseline and 1 month post intervention completion
Secondary outcome [7] 410474 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

6 Change in fatigue - measured by Modified Fatigue Impact Scale (MFIS-5)
Timepoint [7] 410474 0
Baseline and 1 month post intervention completion
Secondary outcome [8] 410475 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

7. Change in intention to retire due to MS - We will assess the perceived likelihood of withdrawing from work entirely, reducing the amount of hours worked due to MS, and changing type of work performed due to MS (in the next 12 months, and in the next five years) .50 Response options for these expectations are made on 5-point Likert-type scales, ranging from 0 (very unlikely) to 4 (very likely).
Timepoint [8] 410475 0
Baseline and 1 month post intervention completion
Secondary outcome [9] 410476 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

8. Change in MS Work Change Awareness Scale - This scale assesses awareness and readiness for change at work. It is based on the Change Awareness Questionnaire from Lam et al. It includes 21 items, capturing items related to 3 stages, the pre-contemplation, contemplation, and action stage, with items rated on a 6-point Likert-type scale (1 = strongly disagree, 6 = strongly agree). Sub-scores for each stage can be calculated.
Timepoint [9] 410476 0
Baseline and 1 month post intervention completion
Secondary outcome [10] 410477 0
Collect data on the variability of outcome measures to inform sample size calculations for the fully-powered trial:

9. Change in MS Work Difficulties Questionnaire-23 (MSWDQ-23)
Timepoint [10] 410477 0
Baseline and 1 month post intervention completion
Secondary outcome [11] 410478 0
Estimate the delivery costs of MS WorkSmart by calculating the time to deliver the intervention using participant coaching times.
Timepoint [11] 410478 0
Upon completion of the study
Secondary outcome [12] 410479 0
Levels of satisfaction with the intervention package, the major intervention components (MS WorkSmart Program, My SymptoMS App, Support, Facebook group interactions).
Timepoint [12] 410479 0
1 month post intervention completion
Secondary outcome [13] 410480 0
Feasibility of the support sessions (duration, types of support provided). This will be based on the data collected by the coach during individual coaching sessions. In addition, at the end of the intervention, data will also be collected through a semi-structured interview with the coach.
Timepoint [13] 410480 0
The data is collected throughout the intervention, and interview at the end of the intervention.
Secondary outcome [14] 410481 0
Evaluation of reported adverse events

Adverse events could include:
• A deterioration in a participant’s physical or psychological health associated with doing and implementing MS WorkSmart.
• Accidental injury resulting from the implementation of MS WorkSmart.
• Adverse actions or discrimination in the workplace resulting from the implementation of MS WorkSmart.

As part of the support sessions, coaches will ask whether anything unusual or unexpected happened since they spoke last. This information will be recorded in the MS WorkSmart REDCap database. This will also occur in the Feedback Survey in participants randomised to the MS WorkSmart Program.

If a participant notifies an event that the coach considers could be an Adverse Event, the severity and causal relationship to the MS WorkSmart Program will be queried and recorded. All Adverse Events are reviewed by the MS WorkSmart Medical Team. Any suspected Serious Adverse Event will be reported to the Chief Investigator and the MS WorkSmart Medical Team within 24 hours.
Timepoint [14] 410481 0
Adverse events are collected throughout the intervention and the feedback survey is completed 1 month post intervention completion.
Secondary outcome [15] 410482 0
Quantitative and qualitative evaluation of the Facebook group interactions (number of Facebook interactions per post, percentage of participants engaging with the Facebook group on at least 2, 5 or 10 separate occasions; and the quality of the post in terms of benefit to others) will be combined to assess the benefits of these interactions and weigh them against the time it took for the team to moderate the Facebook group interactions.
Timepoint [15] 410482 0
1 month post intervention completion
Secondary outcome [16] 410483 0
Assessment of the psychometric properties of the MS Work Behaviour Self-Efficacy Scale using Rasch analysis.
Timepoint [16] 410483 0
Upon completion of the study
Secondary outcome [17] 410635 0
Assessment of the psychometric properties of the MS Work Change Awareness Scale using Rasch analysis.
Timepoint [17] 410635 0
Upon completion of the study

Eligibility
Key inclusion criteria
1. A self-reported diagnosis with MS.
2. MS-Work Instability Score (MS-WIS)>10
3. Regular employment of 10 or more hours/week
4. Aged 18-60 years
5. Access to the internet
6. Adequate understanding of English sufficient to complete the study
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participating in another symptom management or vocational rehabilitation trial.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be automated through REDCap. Individuals will be allocated in a one-to-one ratio to either the intervention group or control group, using block randomisation with a block size of four.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis will be used to assess the recruitment, adherence and drop-out and quantitative feedback surveys. This will be primarily descriptive (with 95% confidence intervals). We will conduct a process evaluation of the conduct of the study.

Using descriptive analysis, we will estimate:
• Recruitment rates and report reasons for non-participation.
• Drop-out rates, and report reasons for drop-out
• Overall levels of adherence (completion of MS WorkSmart modules, support sessions)
• Levels of participation in voluntary components (tasks, Facebook participation)

Using descriptive analysis, we will evaluate:
• Levels of satisfaction with the intervention package, the major intervention components (MS WorkSmart Program, My SymptoMS App, Support, Facebook group interactions).
• Participant preferences in relation to the primary outcome measures of the MS WorkSmart Program.
• Feasibility of the support sessions (duration, types of support provided) and assess whether the support sessions can be provided by other types of health professionals.
• The reported adverse events.

We will use quantitative and qualitative analysis to evaluate the Facebook group interactions. This analysis together with the quantitative feedback data will allow us to judge whether we will continue to use this peer support mechanism in the fully powered randomised controlled trial.

While the aim of the study is not to evaluate effectiveness and the study hasn’t been powered to do so, to maximise use of the data, we will calculate preliminary estimates of effect size (with 95% confidence intervals) post intervention, and calculate measures of variation for future sample size calculations. To do this, we will use linear mixed models, with the post-treatment time-point as the outcome and the baseline measure as a covariate as well as other baseline covariates that differ by treatment arm.
In relation to the newly developed MS Work Behaviour Self-Efficacy Scale and the MS Work Change Awareness Scale, we will first conduct a Rasch analysis to assess the psychometric properties of the scales. Based on the Rasch analysis we will remove any redundant items. We then validate the final MS Work Behaviour Self-Efficacy Scale against the New General Self-Efficacy Scale using correlations.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
1/05/2023
Date of last participant enrolment
Anticipated
1/05/2023
Actual
15/07/2023
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
40
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311156 0
Charities/Societies/Foundations
Name [1] 311156 0
IOOF Foundation
Country [1] 311156 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
College of Health and Medicine Research Hub
Office of Research Services, Private Bag 23, Hobart TAS 7001,
Advocate House Level 1, 15 Liverpool Street,
Hobart TAS 7000

Country
Australia
Secondary sponsor category [1] 312509 0
Charities/Societies/Foundations
Name [1] 312509 0
MS Western Australia
Address [1] 312509 0
Level 2, 1133 Albany Highway, Bentley WA 6102
Country [1] 312509 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310684 0
Health and Medical Human Research Ethics Committee (HMHREC) University of Tasmania (KY00009)
Ethics committee address [1] 310684 0
Office of Research Services
Private Bag 1
Hobart TAS 7001
Ethics committee country [1] 310684 0
Australia
Date submitted for ethics approval [1] 310684 0
15/04/2022
Approval date [1] 310684 0
19/10/2022
Ethics approval number [1] 310684 0

Summary
Brief summary
Rationale: Multiple Sclerosis (MS) is a complex neurological disorder of the central nervous system which causes a wide variety of symptoms including problems with fatigue, mobility, muscle function, pain, cognition, speech, bladder function, and vision. Nearly a third of the total cost of MS in Australia results from a loss of income due to sickness and early retirement. An intervention that maximises work productivity and keep people with MS in the workforce for longer can provide a large societal cost saving and improve the quality of life of people with MS.

Overall aim: Test the feasibility of delivering and evaluating a remotely delivered intervention called ‘MS WorkSmart’.

Design: Two-arm randomised controlled trial (unblinded), comparing those receiving the MS WorkSmart package to those receiving usual care.

Participants: Australians with MS who are employed (work 10 or more hrs/week, MS Work Instability Score>10, aged 18-60 years).

Measures: Measures are assessed at baseline and 1-month post intervention. Primary measures include MS-related work productivity loss, and risk of job loss (using the MS Work Instability Scale). Secondary measures include MS work behaviour self-efficacy scale, health-related quality of life (EQ-5D-5L & QQ-5D-5L-Psychosocial), fatigue severity (MFIS-5), impact of symptoms on work, intention to retire due to MS, MS work difficulties (MSWDQ-23), and MS work change awareness scale. Feedback will be obtained 1-month post-intervention from those participating in the MS WorkSmart Program.

Analyses: Descriptive analyses of the recruitment, adherence and fidelity; process evaluation of the experiences of participating in MS WorkSmart, and; calculation of measures of variations for future sample size calculations using linear mixed models.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118510 0
Prof Ingrid van der Mei
Address 118510 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart TAS 7000 Australia
Country 118510 0
Australia
Phone 118510 0
+61 3 62267710
Fax 118510 0
Email 118510 0
Ingrid.vanderMei@utas.edu.au
Contact person for public queries
Name 118511 0
Prof Ingrid van der Mei
Address 118511 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart TAS 7000 Australia
Country 118511 0
Australia
Phone 118511 0
+61 3 62267710
Fax 118511 0
Email 118511 0
Ingrid.vanderMei@utas.edu.au
Contact person for scientific queries
Name 118512 0
Prof Ingrid van der Mei
Address 118512 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart TAS 7000 Australia
Country 118512 0
Australia
Phone 118512 0
+61 3 62267710
Fax 118512 0
Email 118512 0
Ingrid.vanderMei@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified individual participant data will not be available for this study.


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.