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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05374473




Registration number
NCT05374473
Ethics application status
Date submitted
25/04/2022
Date registered
16/05/2022

Titles & IDs
Public title
An Online Lifestyle Modification Course for People With Multiple Sclerosis
Scientific title
An Online Lifestyle Modification Course for People With MS: a Randomised Controlled Trial of Course Effectiveness
Secondary ID [1] 0 0
23458
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Lifestyle modification
BEHAVIORAL - Standard-care

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

Other: Standard-care - containing general health information sourced from standard MS websites.


BEHAVIORAL: Lifestyle modification
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.

BEHAVIORAL: Standard-care
Content in standard-care arm was adapted from MS-related websites
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in physical health-related quality of life from baseline to 6- 12- and 30-month follow-up
Timepoint [1] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Primary outcome [2] 0 0
Change in mental health-related quality of life from baseline to 6- 12- and 30-month follow-up
Timepoint [2] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Secondary outcome [1] 0 0
Change in depression
Timepoint [1] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Secondary outcome [2] 0 0
Change in anxiety
Timepoint [2] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Secondary outcome [3] 0 0
Change in fatigue
Timepoint [3] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Secondary outcome [4] 0 0
Change in disability
Timepoint [4] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)
Secondary outcome [5] 0 0
Change in self-efficacy
Timepoint [5] 0 0
Pre-intervention (Baseline) to post-intervention (6-, 12- and 30-month follow-up)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
945
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandra L Neate, Doctor
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan
Informed consent form



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT05374473