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Trial registered on ANZCTR


Registration number
ACTRN12621000245897
Ethics application status
Approved
Date submitted
28/09/2020
Date registered
8/03/2021
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of an online lifestyle intervention for people with Multiple Sclerosis
Scientific title
An online lifestyle intervention for people with Multiple Sclerosis: feasibility study
Secondary ID [1] 302277 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 319232 0
Condition category
Condition code
Neurological 317198 317198 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an online lifestyle education intervention. The course takes place modularly (6 modules) with key themes in each module: diet, physical activity, vitamin D and sunlight, stress, family incidence, final motivation. Each module contains narrated videos and animations, images with text, polls and quizzes. Modules are self-paced by participants, and participants can start and stop the modules at any time. Each module takes approximately 30 to 60 minutes to complete and will have access to all the modules for the extent of the 6 week study.

The course is based upon the existing Overcoming Multiple Sclerosis 7-step program, which is currently only taught face-to-face. The online course content was designed by a Professor within epidemiology, with many years experience living with and researching on Multiple Sclerosis (MS), and a PhD candidate in epidemiology. The content was adapted from both the face-to-face course and the 7-step course book (3rd edition).

There is peer-to-peer (p2p) communication in the course through forums. This allows for experiential learning on top of the formal modular courses, which ideally replicates the experience that occurs within the face-to-face course.

Analytics of participant access to the course and engagement with the course will be measured using HotJar tool, which provides traffic data through the intervention.
Intervention code [1] 318709 0
Lifestyle
Intervention code [2] 319636 0
Treatment: Other
Comparator / control treatment
The control group is an identically structured online course with different content. The content is generic lifestyle content sourced from MS societies around the world. The goal is to replicate the generic information that many people with MS (PwMS) are exposed to through their healthcare. By including this in a parallel course as opposed to a wait-list control, the effectiveness of the course content rather than taking a course itself can be assessed.
Control group
Placebo

Outcomes
Primary outcome [1] 325273 0
Feasibility, which is >40% of participants in the intervention arm, and >25% in the control arm complete 75% of the modules. These data will be measured by website analytics tool Hotjar, which provides data on traffic and engagement.
Timepoint [1] 325273 0
Feasibility end-point will be analysed at 8 weeks post-intervention commencement.
Secondary outcome [1] 387373 0
Feasibility (qualitative): to explore the experiences of PwMS with the online course and understand what components of the online course worked well and what did not. This outcome will be assessed via semi-structured telephone interviews with participants.
Timepoint [1] 387373 0
Secondary end-point will be analysed post-intervention. The timing of this secondary endpoint is dependent on availability of participants and the speed at which these semi-structured telephone interviews are able to be completed. It is anticipated these data will be collected 8-11 weeks post-intervention commencement.
Secondary outcome [2] 391341 0
Quantitative evaluation: participants will be requested to complete a 7-point Likert scale survey (non-validated) relating to elements of the intervention such as: enjoyability e.g. did you enjoy the course; accessibility e.g. were specific elements of the course an impediment to your ability to access this course in relation to your MS; usability e.g. was it easy to navigate the course and use all the functions within the intervention. These outcomes are all part of a single, composite outcomes.
Timepoint [2] 391341 0
This end-point will be analysed at 8 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
MS diagnosed by a physician.
Lives in Australia, New Zealand, Canada, USA or UK.
Internet connection.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously undertaken an Overcoming Multiple Sclerosis in-person course or engaged with any related material.

Self-diagnosed MS (no physician diagnosis).

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)
Group allocation will be undertaken using computer software, which will randomise participants at the time of registering their login details in the course (post eligibility assessment).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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
Recruitment outside Australia
Country [1] 23023 0
Canada
State/province [1] 23023 0
All
Country [2] 23024 0
New Zealand
State/province [2] 23024 0
All
Country [3] 23025 0
United Kingdom
State/province [3] 23025 0
All
Country [4] 23026 0
United States of America
State/province [4] 23026 0
All

Funding & Sponsors
Funding source category [1] 306704 0
Charities/Societies/Foundations
Name [1] 306704 0
Overcoming Multiple Sclerosis Foundation
Address [1] 306704 0
Level 1 / 23-27 Wellington Street
St Kilda VIC 3182
Country [1] 306704 0
Australia
Primary sponsor type
Individual
Name
William Bevens
Address
Melbourne School of Population and Global Health, the University of Melbourne, 207 Bouverie St, Carlton VIC 3053.
Country
Australia
Secondary sponsor category [1] 307408 0
Individual
Name [1] 307408 0
Professor George Jelinek
Address [1] 307408 0
Melbourne School of Population and Global Health, the University of Melbourne, 207 Bouverie St, Carlton VIC 3053.
Country [1] 307408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306875 0
The University of Melbourne, Office for Research Ethics and Integrity
Ethics committee address [1] 306875 0
1/21 Bedford St, North Melbourne VIC 3051
Ethics committee country [1] 306875 0
Australia
Date submitted for ethics approval [1] 306875 0
01/05/2019
Approval date [1] 306875 0
11/06/2019
Ethics approval number [1] 306875 0
1851781.2

Summary
Brief summary
The treatment of multiple sclerosis (MS) with immunomodulatory drugs play an important role for many people with MS (PwMS) in modifying disease progression. However, many come with significant side-effects. It has long been understood that lifestyle factors can impact the progression and outcome of MS, with programs targeting lifestyle components in PwMS describing improved quality-of-life (QoL) outcomes, disability, fatigue and mental health outcomes.
The effectiveness of the Overcoming MS (OMS) lifestyle modification program is established from multiple studies describing better patient-reported outcomes compared to PwMS that do not attend the residential lifestyle intervention. With the success of the program in a modest, representative sample of the population of PwMS, transition of the program from a face-to-face, fee for service intervention into a freely available online course is the next step to maximise reach.
Web-based interventions have shown great efficacy at promoting positive lifestyle changes in a range of populations for a variety of conditions, including MS. To date, no
evidence-based lifestyle modification program for PwMS has been translated into a web-based intervention and tested in a randomised control trial (RCT).
An online course would have a reach essentially unimpeded by geography; overcoming distance is crucial as approximately one-third of PwMS in Australia live in regional, rural or remote areas. Furthermore, mobility issues impact many PwMS and travelling to the sites where face-to-face interventions take place can pose a significant burden. Compared to other populations, PwMS are a highly-motivated population that show modest levels of engagement and retention in lifestyle management programs, and previous online self-assessments show good levels of engagement and retention in the short- and long-term.
The purpose of this study is to establish the feasibility of the online Overcoming MS program.. In the context of this web-based study, feasibility be will considered to mean: 1) significant numbers of participants engaging and completing this study, in both arms; and data collection procedures are well-designed and appropriate length; 2) participants consider the project enjoyable and accessible.
This will involve: 1) evaluation of participant responses to data collection procedures, including long-form baseline and follow-up surveys; 2) qualitative and quantitative evaluation of participant responses to intervention content and platform; 3) quantitative evaluation of participant’s para/metadata on participant, engagement and retention/attrition of the course.
Assessing the accessibility, learnability and desirability of the intervention content and platform, delivery is a crucial component of this and will be explored via post-intervention surveys and qualitative, semi-structured telephone interview. A primary consideration for the development of this online program is accessibility for PwMS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105306 0
Mr William Bevens
Address 105306 0
Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie St, Carlton VIC 3053
Country 105306 0
Australia
Phone 105306 0
+61 0498337231
Fax 105306 0
Email 105306 0
william.bevens@unimelb.edu.au
Contact person for public queries
Name 105307 0
Mr William Bevens
Address 105307 0
Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie St, Carlton VIC 3053
Country 105307 0
Australia
Phone 105307 0
+61 0498337231
Fax 105307 0
Email 105307 0
william.bevens@unimelb.edu.au
Contact person for scientific queries
Name 105308 0
Mr William Bevens
Address 105308 0
Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie St, Carlton VIC 3053
Country 105308 0
Australia
Phone 105308 0
+61 0498337231
Fax 105308 0
Email 105308 0
william.bevens@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All IPD (after de-identification) collected during the study, not only what is published.
When will data be available (start and end dates)?
Data will be made available as soon as publication of the primary findings is published. There is no proposed end date for when data will no longer be available.
Available to whom?
Any person with a valid reason to access the data, which will be at the discretion of the PI. This can include researchers but also members of the public, particularly those with MS and their families, who have an interest in this sort of research.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data can be accessed by request of the PI, and for specific requests to particular aspects of the data set eg. quantitative vs qualitative.

PI can be reached via email at william.bevens@unimelb.edu.au
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9317 0
Study protocol
Citation [1] 9317 0
Link [1] 9317 0
Email [1] 9317 0
william.bevens@unimelb.edu.au
Other [1] 9317 0
Attachment [1] 9317 0
Type [2] 9318 0
Informed consent form
Citation [2] 9318 0
Link [2] 9318 0
Email [2] 9318 0
william.bevens@unimelb.edu.au
Other [2] 9318 0
Attachment [2] 9318 0
Type [3] 9319 0
Ethical approval
Citation [3] 9319 0
Link [3] 9319 0
Email [3] 9319 0
william.bevens@unimelb.edu.au
Other [3] 9319 0
Attachment [3] 9319 0
Summary results
No Results