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BMC Neurology
Published in: BMC Neurology 1/2023

Open Access 01-12-2023 | Multiple Sclerosis | Study Protocol

Study protocol for an online lifestyle modification education course for people living with multiple sclerosis: the multiple sclerosis online course (MSOC)

Authors: Jeanette C Reece, Maggie Yu, William Bevens, Steve Simpson-Yap, George Jelinek, Pia Jelinek, Rebekah Davenport, Nupur Nag, Kathleen Gray, Sandra Neate

Published in: BMC Neurology | Issue 1/2023

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Abstract

Background

People living with multiple sclerosis (plwMS) seek access to information on evidence-based lifestyle-related risk factors associated with multiple sclerosis (MS). As the internet has made delivery of lifestyle information increasingly accessible and cost-effective, we designed the Multiple Sclerosis Online Course (MSOC) to deliver a multimodal lifestyle modification program for plwMS. Two MS online courses were developed: the intervention course based on lifestyle recommendations of the Overcoming Multiple Sclerosis (OMS) program and the standard-care course representing standard lifestyle recommendations from other MS websites. We examined for feasibility in a pilot randomised controlled trial (RCT), where satisfactory completion and accessibility were achieved across both study arms. From this success, a protocol for a larger RCT was developed to examine the effectiveness of MSOC in improving health-related quality of life (HRQoL) and other health outcomes in plwMS.

Methods/design

This single-blinded RCT will recruit n = 1,054 plwMS. Participants in the intervention arm will receive access to a MSOC with seven modules providing evidence-based information on the OMS program. Participants in the control group will receive access to a MSOC of identical format, with seven modules providing general MS-related information and lifestyle recommendations sourced from popular MS websites, e.g. MS societies. Participants will complete questionnaires at baseline and at 6, 12, and 30 months after course completion. The primary endpoint is HRQoL, as measured by MSQOL-54 (both physical and mental health domains) at 12 months following course completion. Secondary outcomes are changes to depression, anxiety, fatigue, disability, and self-efficacy as measured by Hospital Anxiety and Depression Scale, Patient-Determined Disease Steps and University of Washington Self-Efficacy Scale, respectively, assessed at each timepoint. Further assessments will include quantitative post-course evaluation, adoption and maintenance of behaviour change from follow-up survey data, and qualitative analysis of participants’ outcomes and reasons for course completion or non-completion.

Discussion

This RCT aims to determine whether an online intervention course delivering evidence-based lifestyle modification recommendations based on the Overcoming Multiple Sclerosis program to plwMS is more effective at improving HRQoL, and other health outcomes post-intervention, compared with an online standard-care course.

Trial registration

This trial was registered prospectively with the Australian New Zealand Clinical Trials Registry, www.​anzctr.​org.​au, identifier ACTRN12621001605886.

Date of registration

25 November 2021.
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Metadata
Title
Study protocol for an online lifestyle modification education course for people living with multiple sclerosis: the multiple sclerosis online course (MSOC)
Authors
Jeanette C Reece
Maggie Yu
William Bevens
Steve Simpson-Yap
George Jelinek
Pia Jelinek
Rebekah Davenport
Nupur Nag
Kathleen Gray
Sandra Neate
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2023
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-023-03298-0

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