ANZCTR - Registration

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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

22/12/2021

Date data sharing statement initially provided

8/03/2021

Type of registration

Retrospectively 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]

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

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]

Lifestyle

Intervention code [2]

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]

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]

Feasibility end-point will be analysed at 8 weeks post-intervention commencement.

Secondary outcome [1]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

31/03/2021

Actual

3/03/2021

Date of last participant enrolment

Anticipated

12/04/2021

Actual

25/04/2021

Date of last data collection

Anticipated

31/05/2021

Actual

24/07/2021

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

Canada

State/province [1]

All

Country [2]

New Zealand

State/province [2]

All

Country [3]

United Kingdom

State/province [3]

All

Country [4]

United States of America

State/province [4]

All

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Overcoming Multiple Sclerosis Foundation

Address [1]

Level 1 / 23-27 Wellington Street
St Kilda VIC 3182

Country [1]

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]

Individual

Name [1]

Professor George Jelinek

Address [1]

Melbourne School of Population and Global Health, the University of Melbourne, 207 Bouverie St, Carlton VIC 3053.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Melbourne, Office for Research Ethics and Integrity

Ethics committee address [1]

1/21 Bedford St, North Melbourne VIC 3051

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2019

Approval date [1]

11/06/2019

Ethics approval number [1]

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

Mr William Bevens

Address

Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie St, Carlton VIC 3053

Country

Australia

Phone

+61 0498337231

Fax

william.bevens@unimelb.edu.au

Contact person for public queries

Name

William Bevens

Address

Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie St, Carlton VIC 3053

Country

Australia

Phone

+61 0498337231

Fax

william.bevens@unimelb.edu.au

Contact person for scientific queries

Name

William Bevens

Address

Melbourne School of Population and Global Health, The University of Melbourne, 207 Bouverie St, Carlton VIC 3053

Country

Australia

Phone

+61 0498337231

Fax

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?

Doc. No.	Type	Email
9317	Study protocol	william.bevens@unimelb.edu.au
9318	Informed consent form	william.bevens@unimelb.edu.au
9319	Ethical approval	william.bevens@unimelb.edu.au

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.

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