ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple Sclerosis

Condition category

Condition code

Neurological

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]

Behaviour

Intervention code [2]

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]

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]

After the recruitment has been completed.

Primary outcome [2]

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]

Upon completion of the study

Primary outcome [3]

Number of MS WorkSmart Program modules and tasks completed by accessing website analytics and coach data.

Timepoint [3]

Upon completion of the study

Secondary outcome [1]

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]

1 month post intervention completion

Secondary outcome [2]

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]