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Multiple SclerosisNCT05374473

An Online Lifestyle Modification Course for People With Multiple Sclerosis

A study testing Lifestyle modification and Standard-care in people with Multiple Sclerosis, run by University of Melbourne at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Lifestyle modification and Standard-care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
945 participants
Where
1 siteAustralia
Study dates
24 Jun 2022to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
  • Currently participating in another study or self-management program involving modification of lifestyle.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The University of Melbourne

    Melbourne, Victoria, 3010

Other trials in Australia

About this study

Official title: An Online Lifestyle Modification Course for People With MS: a Randomised Controlled Trial of Course Effectiveness

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.

Read more

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.

Being tested
Lifestyle modification, Standard-care
Keywords
Randomised controlled trial, Lifestyle modification, Online intervention
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle modificationBehavioural

    Content in the intervention arm was adapted from an evidence-based lifestyle modification program for people with MS outlined in print previously presented in a face-to-face format. The integrated lifestyle modification program translates the research evidence regarding modification of lifestyle related risk factors and health outcomes based on a detailed review of the literature around modifiable lifestyle risk factors that may influence MS disease progression, as outlined in the book Overcoming Multiple Sclerosis: the 7-step recovery program.

  • Standard-careBehavioural

    Content in standard-care arm was adapted from MS-related websites

Study groups in NCT05374473
Study groupRoleWhat they receive
InterventionExperimentalIntervention-tailored program with information regarding modifiable lifestyle related risk factors implicated in disease progression.
Receives: Behavioral: Lifestyle modification
Standard-careOthercontaining general health information sourced from standard MS websites.
Receives: Behavioral: Standard-care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical health-related quality of life from baseline to 6- 12- and 30-month follow-up

    Health-related quality of life will be measured using the Multiple Sclerosis Quality of Life survey (MSQOL-54) (Vickrey, Hays, Harooni, Myers, \& Ellison, 1995). The MSQoL-54 is a psychometrically validated, MS-specific, multi-dimensional inventory of patient-centered health status, and consists of 54 questions on items relevant to people with Multiple Sclerosis in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, and pain and social function. A physical and a mental dimension underlie the MSQOL-54: the Physical Health Composite (PHC) and Mental Health Composite (MHC). PHC scores range from 0 to 100, where higher values indicate better physical quality of life. Changes in PHC scores (from baseline to 6- 12- and 30-month follow-up) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

  2. Change in mental health-related quality of life from baseline to 6- 12- and 30-month follow-up

    Health-related quality of life will be measured using the Multiple Sclerosis Quality of Life survey (MSQOL-54)(Vickrey, Hays, Harooni, Myers, \& Ellison, 1995). The MSQoL-54 is a psychometrically validated, MS-specific, multi-dimensional inventory of patient-centered health status, and consists of 54 questions on items relevant to people with Multiple Sclerosis in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, and pain and social function. A physical and a mental dimension underlie the MSQOL-54: the Physical Health Composite (PHC) and Mental Health Composite (MHC). MHC scores range from 0 to 100, where higher values indicate better mental quality of life. Changes in MHC scores (from baseline to 6- 12- and 30-month follow-up) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

Secondary outcomes (5)

  1. Change in depression

    Participants in the intervention group will be compared to those in the standard-care group on their changes in depression from baseline to 6-, 12- and 30-month follow-up. The Hospital Anxiety and Depression Scale (HADS) is used to measure depressive symptoms. The HADS is commonly used for screening for anxiety and depression, as well as selecting and monitoring treatment and has been used to measure anxiety and depression in Multiple Sclerosis (Zigmond \& Snaith, 1983). The HADS contains 14 items and consists of two subscales: anxiety and depression. The depression subscale ranges from 0 to 21 points. Scores of 11 or more indicate a significant condition of depression, with scores of 8-10 represents 'mild to moderate' and 0-7 'no depression'. Changes in depression (increased or decreased depression scores and shifted depression classification) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

  2. Change in anxiety

    Participants in the intervention group will be compared to those in the standard-care group on their changes in anxiety, from baseline to 6-, 12- and 30-month follow-up. The Hospital Anxiety and Depression Scale (HADS) is used to measure anxiety. The HADS is commonly used for screening for anxiety and depression, as well as selecting and monitoring treatment and has been used to measure anxiety and depression in Multiple Sclerosis (Zigmond \& Snaith, 1983). The HADS contains 14 items and consists of two subscales: anxiety and depression. The anxiety subscale ranges from 0 to 21 points. Scores of 11 or more indicate a significant condition of anxiety, with scores of 8-10 represents 'mild to moderate' and 0-7 'no anxiety'. Changes in anxiety (increased or decreased anxiety scores or shifted anxiety classification) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

  3. Change in fatigue

    Participants in the intervention group will be compared to those in the standard-care group on changes in fatigue from baseline to 6-, 12- and 30-month follow-up. Fatigue will be measured by the 9-item Fatigue Severity Scale (FSS)(Krupp, LaRocca, Muir-Nash, \& Steinberg, 1989). The FSS has mean score range from 1-7, with higher score indicates more fatigue. A mean score ≥ 4 will be used as a cut-off to indicate clinically significant fatigue. A meaningful change on the FSS has been reported demonstrated to be a change of ≥1.9 points in people with MS (Learmonth et al., 2013) and so here a change in mean score of 1.9 points or more will be considered clinically meaningful. Changes in fatigue (increased or decreased fatigue scores or shifted fatigue classification) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

  4. Change in disability

    Participants in the intervention group will be compared to those in the standard-care group on their changes in level of disability, from baseline to 6-, 12- and 30-month follow-up. The Patient-Determined Disease Steps (PDDS) will be used to measure disability (Hohol, Orav, \&Weiner, 1999). The PDDS is a self-reported measure of disability, scored ordinally from 0 (normal) to 8 (bed bound) with detail descriptors and definitions. Changes in disability (increased or decreased PDDS scores) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

  5. Change in self-efficacy

    Participants in the intervention group will be compared to those in the standard-care group on changes in self-efficacy (the belief in one's ability to produce the effects or outcomes one wants). Self-efficacy will be measured using the University of Washington Self-Efficacy (UWSE) survey, a psychometrically sound instrument that includes 6 items for measuring self-efficacy, validated in MS (Amtmann et al., 2012). UWSE MS total score range from 6 to 30, higher scores indicate higher self-efficacy. Total scores will be converted to standardised T-scores, which have a mean of 50 and standard deviation of 10. Higher T-scores indicate greater self-efficacy. Changes in self-efficacy (increased or decreased T-scores) will be assessed and compared between participants in the intervention and standard care groups.

    Measured: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start24 Jun 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
945 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374473
Sponsor's protocol ID
23458
Status last verified
Dec 2023
First submitted
25 Apr 2022
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jelinek, G. (2016). Overcoming multiple sclerosis: the evidence-based 7 step recovery program. Atlantic Books.

  • Marck CH, De Livera AM, Brown CR, Neate SL, Taylor KL, Weiland TJ, Hadgkiss EJ, Jelinek GA. Health outcomes and adherence to a healthy lifestyle after a multimodal intervention in people with multiple sclerosis: Three year follow-up. PLoS One. 2018 May 23;13(5):e0197759. doi: 10.1371/journal.pone.0197759. eCollection 2018.

    PubMed 29791509

  • Hadgkiss EJ, Jelinek GA, Weiland TJ, Pereira NG, Marck CH, van der Meer DM. The association of diet with quality of life, disability, and relapse rate in an international sample of people with multiple sclerosis. Nutr Neurosci. 2015 Apr;18(3):125-36. doi: 10.1179/1476830514Y.0000000117. Epub 2014 Mar 17.

    PubMed 24628020

  • Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

    PubMed 7613530

  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

    PubMed 2803071

  • Learmonth YC, Dlugonski DD, Pilutti LA, Sandroff BM, Motl RW. The reliability, precision and clinically meaningful change of walking assessments in multiple sclerosis. Mult Scler. 2013 Nov;19(13):1784-91. doi: 10.1177/1352458513483890. Epub 2013 Apr 15.

    PubMed 23587605

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Hohol MJ, Orav EJ, Weiner HL. Disease steps in multiple sclerosis: a longitudinal study comparing disease steps and EDSS to evaluate disease progression. Mult Scler. 1999 Oct;5(5):349-54. doi: 10.1177/135245859900500508.

    PubMed 10516779

  • Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington self-efficacy scale: a new self-efficacy scale for people with disabilities. Arch Phys Med Rehabil. 2012 Oct;93(10):1757-65. doi: 10.1016/j.apmr.2012.05.001. Epub 2012 May 7.

    PubMed 22575393

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle modification and Standard-care in people with Multiple Sclerosis, run by University of Melbourne at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical health-related quality of life from baseline to 6- 12- and 30-month follow-up (time frame: Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374473, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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