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Trial registered on ANZCTR


Registration number
ACTRN12621001605886
Ethics application status
Approved
Date submitted
17/09/2021
Date registered
25/11/2021
Date last updated
18/07/2022
Date data sharing statement initially provided
25/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An online lifestyle modification course for people with multiple sclerosis: a randomised controlled trial of course effectiveness.
Scientific title
The effect of an online lifestyle modfication course for people with multiple sclerosis on quality of life: a randomised controlled trial
Secondary ID [1] 305305 0
Nil known
Universal Trial Number (UTN)
U1111-1269-4254
Trial acronym
MSOC RCT
Linked study record
ACTRN12621000245897. The previous linked trial was the feasiblity study conducted prior to this planned large effectiveness RCT. The feasiblity study, via quantitatve and qualitative analyses, examined content, functionality and learnability of the course and modifications to the course have occurred based on participant feedback to inform redevelopment of the course ready for this RCT. This RCT aims to assess changes to quality of life and health outcomes following course completion.

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 323623 0
Condition category
Condition code
Neurological 321156 321156 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Multiple Sclerosis Online Course (MSOC)

Two arms of the MSOC were developed with the aim of conducting an RCT (an intervention arm and a standard-care arm). Each arm is delivered through the same website. Both arms are identical in format and template designs. Each course is delivered in seven modules over six weeks: introduction and overview of multiple sclerosis (MS), diet, physical activity, exposure to sunlight and vitamin D, stress reduction, family, and concluding remarks. Each module consists of a range of different content types: text, video/animation, audio, interactive tasks, and quizzes. Participant profiles may be uploaded with a photo and any infomration particpants wish to share.
A community forum in each arm is open to participants only. There will be no real time moderation. However platform designers will populate the forums with links to articles to stimluate voluntary discussion between participants without the need for constant moderation. One researcher will review the forums weekly throughout the course to check for appropriateness of content. The designers have incorporated a "word recognition" element that automatically recognises and removes any comment with recognised inappropriate (eg racist, swearing) comments.

However, the intervention arm and standard care arm differ in content.

1) Intervention arm (MS online intervention course)

Content in the intervention arm was adapted from an evidence-based lifestyle modification program for people with MS outlined in print ( Jelinek, G.A. Overcoming multiple sclerosis: the evidence-based 7 step recovery program. 2016. 2nd edition. ISBN 978 1 76011 255 4) 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.

The intervention arms consists of 7 modules that are taken during the online course. Each module takes around one hour to complete. Modules are released on two separate weekdays over a 4-week period but participants are given an extra 2 weeks at the end to complete all modules in the event they cannot complete modules during the 4-week period. The modules are summarised below:

Module 1: Introduction to the program and participants
Welcome to the course and overview of MS (medical definition). How to study the course; introduction to the web-based intervention: how to proceed, how to navigate, what to expect and to outline the endpoints for participants.

Module 2: Diet
Evidence behind a dietary influence on MS disease activity and QOL: evidence on saturated fat, and evidence regarding diet and its relationships with MS onset and progression. Introduction to dietary plan and benefits of different food groups.

Module 3: Sunlight and vitamin D
Detailed background information about how vitamin D is made from the action of sunlight is presented, along with evidence supporting a role of vitamin D in MS disease activity. Recommendations for optimal levels of supplementation and blood levels are presented.

Module 4: Physical activity/Exercise
The benefits of exercise are explained for people with MS (neurological, cognitive, physical), how and why. In addition, evidence regarding the benefits of exercise will be presented. How to implement an exercise plan with video examples provided.

Module 5: Stress and stress reduction
Introduction to mental health and relevance in MS. Participants are introduced to the science behind stress and its link to inflammation/MS. Mind-body connection, meditation and other stress reduction techniques and how to develop a mental health and wellbeing improvement strategy are presented. There is one 10 minute sample voice over guided meditation (asynchronous) by Associate Professor Craig Hassed (Centre for Consciousness and Contemplative Studies, Monash University), world expert on mindfulness. There are no face to face sessions as the course is asynchronous.

Module 6: Family primary prevention
Participants are introduced to the issue of primary prevention of MS in close family members who are at increased risk of developing the disease, and strategies for reducing this risk. This session will cover risks associated with smoking and the risks and benefits of moderate alcohol use.

Module 7: Review and consolidation
Program overview and recap, and an outline of next steps to take. Advise on follow-up questionnaires for longitudinal follow-up, and link to forums for further engagement (aimed at enhancing retention).



Intervention code [1] 321716 0
Lifestyle
Intervention code [2] 321717 0
Behaviour
Intervention code [3] 321718 0
Treatment: Other
Comparator / control treatment
2). Standard-Care Group (MS Online standard-care course):

The content of the standard-care course will be delivered in the same seven modules as the intervention course (as above). Content in the standard-care arm mirrored the intervention course with respect to the topics of modules. Information was sourced entirely from MS society websites in the public domain, including Multiple Sclerosis Australia, Multiple Sclerosis Research Australia, National MS Society, Multiple Sclerosis Society UK, Multiple Sclerosis Society of Canada and aimed to source aspects of the standard information provided to pwMS by heath care practitioners. This information was not a specific set of recommendations but rather encouraged participants to eat a healthy diet, increase their physical activity and engage in activities to reduce stress in their lives. The standard-care course aims to reproduce the advice that people with MS traditionally receive from their medical consultations and online advice from multiple sclerosis societies. The standard care course will also have participant forums with different links appropriate to the standard care arm ie they will not be about the factual content of the intervention arm but will contain general discussion points around diet, exercise etc.
Control group
Active

Outcomes
Primary outcome [1] 328986 0
The first primary outcome for this study is change in Physical Health Composite (PHC) score from the MSQOL-54 (Multiple Sclerosis Quality Of Life-54) questionnaire. The MSQOL-54 is a 54-item psychometrically validated tool that is used to measure a spectrum of health-related quality of life in people with MS.

The PHC is derived by combining scores of relevant subscales.1 Differences of at least five points from baseline have previously been determined as the minimum clinically meaningful change in an HRQOL measure.2,3 This is based on recommendations that a difference equivalent to half the standard deviation be universally considered an important magnitude for all HRQOL tools,4 and previous data suggests a difference of five points is achievable in a sample of people with MS.5


References

1. Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res 1995; 4(3): 187-206.
2. Taphoorn MJ, Bottomley A. Health-related quality of life and symptom research in glioblastoma multiforme patients. Expert Rev Pharmacoecon Outcomes Res 2005; 5(6): 763-74.
3. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16(1): 139-44.
4. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003; 41(5): 582-92.
5. Hadgkiss EJ, Jelinek GA, Taylor KL, et al. Engagement in a program promoting lifestyle modification is associated with better patient-reported outcomes for people with MS. Neurol Sci 2015; 36(6): 845-52.

Timepoint [1] 328986 0
Primary outcomes will be measured in the short-term (at 6 and 12 months (primary timepoint) from baseline) and medium-term (at 2.5 years from baseline)
Primary outcome [2] 329181 0
The second primary outcome for this study is change in Mental Health Composite (MHC) score from the MSQOL-54 (Multiple Sclerosis Quality Of Life-54) questionnaire. The MSQOL-54 is a 54-item psychometrically validated tool that is used to measure a spectrum of health-related quality of life in people with MS.

The MHC is derived by combining scores of relevant subscales.1 Differences of at least five points from baseline have previously been determined as the minimum clinically meaningful change in an HRQOL measure.2,3 This is based on recommendations that a difference equivalent to half the standard deviation be universally considered an important magnitude for all HRQOL tools,4 and previous data suggests a difference of five points is achievable in a sample of people with MS.5


References

1. Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res 1995; 4(3): 187-206.
2. Taphoorn MJ, Bottomley A. Health-related quality of life and symptom research in glioblastoma multiforme patients. Expert Rev Pharmacoecon Outcomes Res 2005; 5(6): 763-74.
3. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16(1): 139-44.
4. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003; 41(5): 582-92.
5. Hadgkiss EJ, Jelinek GA, Taylor KL, et al. Engagement in a program promoting lifestyle modification is associated with better patient-reported outcomes for people with MS. Neurol Sci 2015; 36(6): 845-52.

Timepoint [2] 329181 0
Primary outcomes will be measured in the short-term (at 6 and 12 months (primary timepoint) from baseline) and medium-term (at 2.5 years from baseline)
Secondary outcome [1] 401043 0
The first secondary outcome is change in clinically signficant fatigue from baseline,

Clinically significant fatigue will be measured by the 9-item Fatigue Severity Scale (FSS).1 The FSS has good internal consistency, stability, and sensitivity to change over time.2,3 A mean score equalt to r greater than 4 has been suggested as a cut-off to indicate clinically significant fatigue and is widely used for people with MS.3-5 A meaningful change on the FSS has been reported demonstrated to be a change of greater than 1.9 points in people with MS,6 and so here a change in mean score of 1.9 points or more will be considered clinically meaningful.

References
1. 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; 46(10): 1121-3.
2. Amato MP, Ponziani G, Rossi F, Liedl CL, Stefanile C, Rossi L. Quality of life in multiple sclerosis: the impact of depression, fatigue and disability. Mult Scler 2001; 7(5): 340-4.
3. Smedal T, Beiske AG, Glad SB, et al. Fatigue in multiple sclerosis: associations with health-related quality of life and physical performance. Eur J Neurol 2011; 18(1): 114-20.
4. Marrie RA, Cutter G, Tyry T, Hadjimichael O, Campagnolo D, Vollmer T. Validation of the NARCOMS registry: fatigue assessment. Mult Scler 2005; 11(5): 583-4.
5. Lerdal A, Celius EG, Moum T. Fatigue and its association with sociodemographic variables among multiple sclerosis patients. Mult Scler 2003; 9(5): 509-14.
6. Learmonth, Y., Dlugonski, D., Pilutti, L. A., Sandroff, B. M., Moti, R. W., & Klaren, R. E. (2013). Reliability, Precision and Clinically Meaningful Change Of Fatigue Outcomes In MS. Paper presented at the ACTRIMS. Retrieved from https://cmsc.confex.com/cmsc/2013/webprogram/Paper1612.html




Timepoint [1] 401043 0
Secondary outcomes will be measured in the short-term (at 6 and 12 months from baseline) and medium-term (at 2.5 years from baseline).
Secondary outcome [2] 401722 0
The second secondary outcome is change in depression from baseline.

The Patient Health Questionnaire (PHQ-9) screens for the presence of and severity of depressive symptoms. The PHQ-9 is commonly used for screening for depression, as well as selecting and monitoring treatment and has been used to measure depression in MS.7 The PHQ-9 as a unidimensional measure of depression has been shown that a PHQ-9>9 indicates depression risk.8

7. Amtmann D, Kim J, Chung H, et al. Comparing CESD-10, PHQ-9, and PROMIS depression instruments in individuals with multiple sclerosis. Rehabil Psychol 2014; 59(2): 220-9.
8. Patrick S, Connick P. Psychometric properties of the PHQ-9 depression scale in people with multiple sclerosis: A systematic review. PLoS One 2019; 14(2): e0197943.
Timepoint [2] 401722 0
Secondary outcomes will be measured in the short-term (at 6 and 12 months from baseline) and medium-term (at 2.5 years from baseline).
Secondary outcome [3] 401723 0
The third secondary outcome is change in patient-reported disability from baseline.

The Patient-Determined Disease Steps (PDDS) is a self-reported measure of ambulatory disability. The PDDS is scored ordinally from 0 (normal) to 8 (bed bound) with detailed descriptors and definitions. It correlates well with the EDSS and moderately with the widely used Multiple Sclerosis Functional Composite and has excellent test-retest reliability. PDDS is considered a practical tool to use to assess changes in disability over time.9 One step will be considered a clinically meaningful change in the PDDS.

9. 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; 5(5): 349-54.

Timepoint [3] 401723 0
Secondary outcomes will be measured in the short-term (at 6 and 12 months from baseline) and medium-term (at 2.5 years from baseline).
Secondary outcome [4] 401724 0
The fourth secondary outcomes is change in percieved control/mastery from baseline.

Mastery (the sense that people can influence their own life and that their outcomes are not fatalistically controlled) will be measured using the Pearlin Mastery Questionnaire, a 7-item questionnaire to assess psychological coping resources by measuring the sense of being in control of one’s life chances.10
10. Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav 1978; 19(1): 2-21.
Timepoint [4] 401724 0
Secondary outcomes will be measured in the short-term (at 6 and 12 months from baseline) and medium-term (at 2.5 years from baseline).

Eligibility
Key inclusion criteria
To be eligible, participants must:
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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria of participants include:
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 MS related study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to either the intervention or standard-care arm by a computer algorithm following eligibility assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per a computer-generated simple randomisation program such as https://www.randomizer.org/.

Participants will be allocated to the intervention or standard-care arm at a 1:1 ratio using stratified block randomization. That is, participants will be identified and assigned into blocks for sex, age, and PDSS/disability groups ((0-3/>3-6/>6). After subjected have been assigned into blocks, a simple randomisation will be performed within each block assigning participants to either the MS Online intervention arm or the MS Online standard-care arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All patients who: 1. fulfil the study inclusion criteria 2. give consent for participation in the study, and 3. complete the baseline assessment questionnaire will be randomised to either the intervention or standard-care arm of the study before being provided with a link to access to the allocated MS Online course.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will measure adherence to lifestyle modification recommendations in people with MS enrolled in the MS Online intervention and the MS Online standard-care arm (control) using validated patient-reported questionnaires.

We will examine and compare clinical and health outcomes of depression, fatigue, disability, mastery and quality of life in people with MS in the short-term (6 months and 12 months from baseline) and medium-term (2.5 years from baseline) in people enrolled in the MS Online Intervention course arm and people enrolled in the MS Online standard-care course arm.

Analysis of outcomes will be examined using the following statistical methods:
Characteristics of quality of life (QoL) will be measured by the MSQOL-54, including physical and mental health composite scores and multiple subdomains and linear regression will be used to determine cross-sectional and prospective relationships with QoL. Characteristics of disability will be assessed using linear regression. Characteristics of dichotomous clinically significant fatigue and depression will be assessed by log-binomial regression. Characteristics of mastery composite scores will be assessed by linear and log-binomial regression for continuous and dichotomised mastery, respectively. All models will be assessed for potential clinical and demographic confounders and appropriate adjustments will be made in analyses. Characteristics of disability will be assessed using linear regression. Characteristics of dichotomous clinically significant fatigue and depression will be assessed by log-binomial regression. Characteristics of mastery composite scores will be assessed by linear and log-binomial regression for continuous and dichotomised mastery, respectively. All models will be assessed for potential confounders and appropriate adjustments will be made in analyses.

Statistical analyses will enable us to examine whether a causal relationship exists between lifestyle factors and clinical and health outcomes in people with MS. These analyses are anticipated to be completed within 6-12 months of collecting data for short-term and long-term analyses, respectively.

For the qualitative arm of the analysis, reflexive thematic analysis of semi-structured interviews will be conducted directed by the content of the data.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24127 0
New Zealand
State/province [1] 24127 0
Country [2] 24128 0
Canada
State/province [2] 24128 0
Country [3] 24129 0
United States of America
State/province [3] 24129 0
Country [4] 24130 0
United Kingdom
State/province [4] 24130 0

Funding & Sponsors
Funding source category [1] 309673 0
University
Name [1] 309673 0
The University of Melbourne
Country [1] 309673 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Centre for Epidemiology and Biostatistics
207 Bouverie Street
Melbourne School of Population & Global Health
The University of Melbourne
Parkville 3010. Victoria
Country
Australia
Secondary sponsor category [1] 310726 0
None
Name [1] 310726 0
Address [1] 310726 0
Country [1] 310726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309441 0
The University of Melbourne Science, Technology, Engineering, Mathematics and Medicine (STEMM 1) Ethics Committee
Ethics committee address [1] 309441 0
The University of Melbourne
Swanston Street,
Parkville 3052
Victoria
Ethics committee country [1] 309441 0
Australia
Date submitted for ethics approval [1] 309441 0
12/09/2021
Approval date [1] 309441 0
02/11/2021
Ethics approval number [1] 309441 0
2021-22140-23054-4

Summary
Brief summary
Lifestyle factors are known to affect the progression of multiple sclerosis (MS). The Multiple Sclerosis Online Course (MSOC)has been developed to deliver a widely accessible and user-friendly educational tool regarding modification of lifestyle related risk factors for people with MS. The intervention consists of arms: 1. an MS Online intervention course based delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and 2. an MS Online 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. Having conducted a feasibility study, (ACTRN12621000245897. ) the purpose of this study is to test the effectiveness of the intervention course compared with the standard-care arm in a larger randomised controlled trial.

The study hypothesis is that undertaking an MS Online Course delivering evidence based information regarding the modification of lifestyle related risk factors will lead to changed behaviours and improved health outcomes for people with MS.
Trial website
https://msonlinecourse.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114170 0
A/Prof Sandra Neate
Address 114170 0
Neuroepidemiology Unit
Centre for Epidemiology and Biostatistics
Melbourne School of Population and Global Health
Level 3, 207 Bouverie Street
The University of Melbourne, Victoria 3010
Country 114170 0
Australia
Phone 114170 0
+61 412877894
Fax 114170 0
Email 114170 0
sandra.neate@unimelb.edu.au
Contact person for public queries
Name 114171 0
A/Prof Sandra Neate
Address 114171 0
Neuroepidemiology Unit
Centre for Epidemiology and Biostatistics
Melbourne School of Population and Global Health
Level 3, 207 Bouverie Street Carlton
The University of Melbourne, Victoria 3010
Country 114171 0
Australia
Phone 114171 0
+61 412877894
Fax 114171 0
Email 114171 0
sandra.neate@unimelb.edu.au
Contact person for scientific queries
Name 114172 0
A/Prof Sandra Neate
Address 114172 0
Neuroepidemiology Unit
Centre for Epidemiology and Biostatistics
Melbourne School of Population and Global Health
Level 3, 207 Bouverie Street Carlton
The University of Melbourne, Victoria 3010
Country 114172 0
Australia
Phone 114172 0
+61 412877894
Fax 114172 0
Email 114172 0
sandra.neate@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participant demographic data and data from participant's self-reported questionnaires
When will data be available (start and end dates)?
The data will be available at the completion of all data analyses and publication of peer-review papers by the Neuroepidemiology Unit. The data will be available for 5 years post publication.
Available to whom?
If relevant, data may be shared with potential researchers who wish to collaborate on the study.
Potential researchers include researchers such as Dr Julie Campbell from the University of Tasmania who specialise in health economics and health service utilities research.
Available for what types of analyses?
Quantitative statistical analyses
Qualitative analyses
How or where can data be obtained?
The data will only be a available on a secure folder at the University of Melbourne. The data may be obtained by request to Dr Sandra Neate. Send enquiry to sandra.neate@unimelb.edu.au


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    382778-(Uploaded-17-09-2021-14-24-18)-Study-related document.pdf
Informed consent form    382778-(Uploaded-17-09-2021-14-26-02)-Study-related document.docx
Other    Core self-reported questionnaire 382778-(Uploaded-17-09-2021-14-27-35)-Study-related document.pdf
Other    Plain language statement 382778-(Uploaded-17-09-2021-14-27-56)-Study-related document.docx
Other    Advertisement to recruit people with MS to partici... [More Details] 382778-(Uploaded-17-09-2021-14-28-12)-Study-related document.docx
Other    Consent form to participate in qualitative compone... [More Details] 382778-(Uploaded-17-09-2021-14-34-50)-Study-related document.docx
Other    Email invitation to participate in qualitative com... [More Details] 382778-(Uploaded-17-09-2021-14-36-15)-Study-related document.docx
Other    Form to withdraw from MSOC - RCT 382778-(Uploaded-17-09-2021-14-37-14)-Study-related document.doc
Other    Qualitative interview schedule 382778-(Uploaded-17-09-2021-14-43-29)-Study-related document.docx
Other    Distress protocol for participants in US 382778-(Uploaded-17-09-2021-14-44-05)-Study-related document.doc
Other    Distress protocol for participants in Australia 382778-(Uploaded-17-09-2021-14-44-41)-Study-related document.doc
Other    Distress protocol for participants in New Zealand 382778-(Uploaded-17-09-2021-14-45-08)-Study-related document.doc
Other    Distress protocol for participants in Canada 382778-(Uploaded-17-09-2021-14-45-31)-Study-related document.doc
Other    Distress protocol for participants in UK 382778-(Uploaded-17-09-2021-14-45-51)-Study-related document.doc


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for an online lifestyle modification education course for people living with multiple sclerosis: the multiple sclerosis online course (MSOC).2023https://dx.doi.org/10.1186/s12883-023-03298-0
N.B. These documents automatically identified may not have been verified by the study sponsor.