Feasibility Study of MSOC RCT 2021

Funding

Charities/Societies/Foundations,Overcoming Multiple Sclerosis Foundation

Scientific enquiries

Mr William Bevens

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 .... 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.
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Key Inclusion Criteria

MS diagnosed by a physician. Lives in Australia, New Zealand, Canada, USA or UK. Internet connection.

Key Exclusion Criteria

Previously undertaken an Overcoming Multiple Sclerosis in-person course or engaged with any related material. Self-diagnosed MS (no physician diagnosis).