An Online Lifestyle Modification Course for People With Multiple Sclerosis

NCT05374473 | Unknown

• 1 other identifier: 23458
• Study Type: interventional
• Target: 945
• Locations: 1 country
• Sites: 1

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. 1.an intervention course delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and
2. 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.

Conditions

Multiple Sclerosis

Keywords

Randomised controlled trial; Lifestyle modification; Online intervention

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Change in depression

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

• Change in anxiety

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

• Change in fatigue

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

• Change in disability

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

• Change in self-efficacy

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

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention-tailored program with information regarding modifiable lifestyle related risk factors implicated in disease progression.

Behavioral: Lifestyle modification

Standard-care

OTHER

containing general health information sourced from standard MS websites.

Behavioral: Standard-care

Interventions

Lifestyle modification BEHAVIORAL

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.

Intervention

Standard-care BEHAVIORAL

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

Standard-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

The University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (9)

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

  BACKGROUND

• 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.

  PMID: 29791509 BACKGROUND

• 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.

  PMID: 24628020 RESULT

• 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.

  PMID: 7613530 RESULT

• 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.

  PMID: 2803071 RESULT

• 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.

  PMID: 23587605 RESULT

• 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.

  PMID: 6880820 RESULT

• 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.

  PMID: 10516779 RESULT

• 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.

  PMID: 22575393 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sandra L Neate, Doctor

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 16, 2022
• Study Start: June 24, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)