Clinical trial NCT05374473: An Online Lifestyle Modification Course for People With Multiple Sclerosis
Official title: An Online Lifestyle Modification Course for People With MS: a Randomised Controlled Trial of Course Effectiveness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Randomised controlled trial
Lifestyle modification
Online intervention
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two forms of the course were developed:

1. an intervention course based delivering evidence based information regarding modifiable lifestyle related risk factors implicated in disease progression; and
2. a standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lifestyle factors are known to affect the progression of multiple sclerosis (MS). Studies of participants with MS attending an evidence-based lifestyle modification program, delivered via face-to-face workshops, have demonstrated improved mental and physical health, reduced relapse rate and improved quality of life over 3 years follow up, and that behaviour change was feasible and sustainable. However, the face-to-face modality of this educational intervention is resource intensive, and accessibility may be impeded by geography, cost, and MS-specific factors such as illness, fatigue, and disability. Furthermore, the COVID-19 pandemic has highlighted the unpredictable ability to travel and the importance of flexibility of health-related education.

The Neuroepidemiology Unit at the University of Melbourne has developed the Multiple Sclerosis Online Course (MSOC) to deliver a widely accessible and user-friendly educational tool for people with MS. The course aims to deliver the best available evidence regarding lifestyle-related risk factors in the development and progression of MS and behaviour modification to improve health outcomes.

Two forms of the course were developed:

1. an intervention course delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and
2. a standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites. Both courses have seven modules delivered over six weeks.

A feasibility study involving the delivery of the intervention and standard-care course was conducted from April to June 2021. The study assessed the primary outcomes of attrition in both intervention and standard-care arm. Secondary outcomes assessed assessed learnability, accessibility, and desirability via a Likert scale follow-up survey. A qualitative analysis examining motivation, expectations and outcomes was also conducted. Tertiary outcomes assessed the completion of the baseline surveys, a requirement to enter the course. Based on the feasibility study, the investigators have modified recruitment strategies, functionality, and the community forum aspects of the course. Investigators now aim to test the effectiveness of the intervention arm of the course versus the standard-care arm in a larger randomised controlled trial.

Objective:

To prospectively examine whether an MS Online intervention course (intervention arm) can deliver an evidence-based educational intervention that results in behaviour change which can be sustained and translated into improved health outcomes for people with MS, and whether these effects are superior to the MS Online standard-care course (control arm).

Participants who are 18 or older, diagnosed with multiple sclerosis by a doctor are welcome to join our study.

The online course will run for 6 weeks. During this time, there are no formal assessments or minimum time investment required, which means participants are free to navigate the course as they see fit.

Prior to commencing the study, participants will be asked fill-out a survey about their health (e.g., fatigue) and lifestyle (e.g., diet) and will be asked to fill this out again during the study.


Eligibility criteria: Inclusion Criteria:

1. Be able to read, write, and speak English;
2. Be 18 years old or over;
3. Have a confirmed diagnosis of relapsing-remitting MS by a neurologist;
4. Be able to access the internet and be able to view sessions.

Exclusion Criteria:

1. Experiencing any serious co-morbid chronic illness or neurological illness/injury other than MS that would threaten regular participation or significantly affect the outcome measures in its own right, such as motor neurone disease or stroke, as determined by the study investigators;
2. Currently participating in another study or self-management program involving modification of lifestyle.

Primary outcomes:
measure: Change in physical health-related quality of life from baseline to 6- 12- and 30-month follow-up
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
measure: Change in mental health-related quality of life from baseline to 6- 12- and 30-month follow-up
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Secondary outcomes:
measure: Change in depression
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
measure: Change in anxiety
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
measure: Change in fatigue
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
measure: Change in disability
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
measure: Change in self-efficacy
timeFrame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Sandra L Neate, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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