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Trial registered on ANZCTR


Registration number
ACTRN12620000908932
Ethics application status
Approved
Date submitted
23/07/2020
Date registered
14/09/2020
Date last updated
14/09/2020
Date data sharing statement initially provided
14/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Making it Personal: Managing Chronic Symptoms in Multiple Sclerosis
Scientific title
Making it Personal: Managing Chronic Symptoms in Multiple Sclerosis: A Series of N-of-1 Observational Studies investigating Patterns and Predictors of Fatigue
Secondary ID [1] 301860 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 318356 0
Condition category
Condition code
Neurological 316365 316365 0 0
Multiple sclerosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Multiple sclerosis (MS) is a condition of the central nervous system, where there is interference in the nerve impulses within the brain, spinal cord and optic nerves. Scars occur within the central nervous system and depending on where they develop, manifest into various symptoms. Some symptoms include problems with motor control (muscle spasms, weakness, lack of coordination/balance and functioning of arms and legs) neuropsychological issues (memory loss and cognitive issues), bladder and bowel incontinence, and other neurological symptoms such as vertigo, pins and needles, neuralgia and visual disturbances. Fatigue is among the most commonly reported, most disabling but least understood symptom experienced by patients with Multiple Sclerosis (MS). Patients differ substantially in the symptoms they experience depending on where lesions have developed on the brain and spinal cord. Factors such as physical/cognitive activity, sleep, stress and mood may trigger or worsen symptoms.

In this study, variables including physical activity, sleep, stress, mood and fatigue are measured on a daily basis for period of 6-12 weeks via an electronic diary with an inbuilt accelerometer. Variables related to personally-relevant symptoms (e.g. body pain) and potential triggers of symptom exacerbations (e.g. sleep) are selected by participants at the start of the study and also added to the daily questionnaires. Brief questionnaires will be completed by participants three times per day (morning, afternoon and evening) and will take approximately 1-2 minutes to complete.
Intervention code [1] 318152 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324527 0
The severity of physical fatigue measured on a 100mm visual analogue scale. The measure is designed specifically for this study. The data is analysed at the individual (N-of-1) level.
Timepoint [1] 324527 0
Three times per day (morning, afternoon and evening) for 6-12 weeks (duration of data collection period based on the preference of the participant).
Primary outcome [2] 324528 0
The severity of cognitive fatigue measured on a 100mm visual analogue scale. The measure is designed specifically for this study. The data is analysed at the individual (N-of-1) level.
Timepoint [2] 324528 0
Three times per day (morning, afternoon and evening) for 6-12 weeks (duration of data collection period based on the preference of the participant).
Secondary outcome [1] 384885 0
The severity of a personally-relevant symptom (e.g. body pain) selected by the participant at the start of the study measured on a 100mm visual analogue scale. The measure is designed specifically for this study. The data is analysed at the individual (N-of-1) level. If more than one symptom is selected by the participant, it will be analysed as another secondary outcome (i.e. not a composite measure).
Timepoint [1] 384885 0
Three times per day (morning, afternoon and evening) for 6-12 weeks (duration of data collection period based on the preference of the participant).
Secondary outcome [2] 385798 0
Acceptability of the study procedures
Timepoint [2] 385798 0
Semi-structured interviews will be conducted at the end of the study to explore participant views about the study procedures
Secondary outcome [3] 385799 0
Feasibility of study procedures
Timepoint [3] 385799 0
Feasibility will be assessed by calculating the completion rate of daily questionnaires during the study for each participant after the data collection period is completed.

Eligibility
Key inclusion criteria
Adults 18 years or older with a medical diagnosis of Multiple Sclerosis. Individuals are not excluded on the basis of their gender, age or overall health status.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical power in N-of-1 studies is determined by the number of repeated measurements from the same individual. Therefore, there are no sample size requirements related to the number of participants recruited.

Individual level and aggregated analyses will be performed. Individual level analyses will be conducted using Bayesian time series analysis. Aggregated analyses will be conducted using Bayesian hierarchical models.

Recruitment
Recruitment status
Not yet 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)
QLD

Funding & Sponsors
Funding source category [1] 306282 0
University
Name [1] 306282 0
The University of Queensland
Address [1] 306282 0
Centre for Clinical Research,
Building 71/918,
Royal Brisbane & Women's Hospital Campus
Herston,
Queensland,
4029
Country [1] 306282 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
UQ Centre for Clinical Research
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 306773 0
None
Name [1] 306773 0
Address [1] 306773 0
Country [1] 306773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306498 0
The University of Queensland Medicine Faculty Low or Negligible Risk Sub-Committee
Ethics committee address [1] 306498 0
Oral Health Centre
Level 6, Oral Health Centre (883),
288 Herston Road,
Herston,
Queensland
4006
Ethics committee country [1] 306498 0
Australia
Date submitted for ethics approval [1] 306498 0
07/07/2020
Approval date [1] 306498 0
10/07/2020
Ethics approval number [1] 306498 0
#2018000741

Summary
Brief summary
This research study aims to explore intra-individual variability in symptoms over time and intra-individual predictors of symptom severity. A series of N-of-1 observational studies with individuals with Multiple Sclerosis (MS) will be conducted. The study also aims to assess the acceptability and feasibility of participating in N-of-1 observational studies from the perspective of individuals with MS. This will be achieved by conducting semi-structured interviews with participants at the end of the study and by examining participant adherence to study procedures (e.g. questionnaire completion rates).
Trial website
https://clinical-research.centre.uq.edu.au/research/clinical-neuroscience/n-1-trials-and-sleep-research/making-it-personal-managing-chronic-symptoms-using-scientific-insights-n-1-studies
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104074 0
Dr Suzanne McDonald
Address 104074 0
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Country 104074 0
Australia
Phone 104074 0
+61 0490936307
Fax 104074 0
Email 104074 0
suzanne.mcdonald@uq.edu.au
Contact person for public queries
Name 104075 0
Dr Suzanne McDonald
Address 104075 0
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Country 104075 0
Australia
Phone 104075 0
+61 0490936307
Fax 104075 0
Email 104075 0
suzanne.mcdonald@uq.edu.au
Contact person for scientific queries
Name 104076 0
Dr Suzanne McDonald
Address 104076 0
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Country 104076 0
Australia
Phone 104076 0
+61 0490936307
Fax 104076 0
Email 104076 0
suzanne.mcdonald@uq.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?
All data collected from each participant is analysed at the individual level. Participants are informed that their data may be combined with other data at a future date (e.g. for meta-analysis) and provide consent for their data to be used in further research.
When will data be available (start and end dates)?
Immediately following publication; no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Suzanne McDonald; suzanne.mcdonald@uq.edu.au)
What supporting documents are/will be available?
No other documents available
Summary results
No Results