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Trial registered on ANZCTR


Registration number
ACTRN12618001898246
Ethics application status
Approved
Date submitted
9/11/2018
Date registered
22/11/2018
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Making it Personal: Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Scientific title
Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome using Insights from N-of-1 Studies: A Series of N-of-1 Observational Studies
Secondary ID [1] 296328 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
310038 0
Condition category
Condition code
Other 308788 308788 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ME/CFS is a complex, multi-system, neuroimmune condition with a multitude of symptoms. Some symptoms include post-exertional fatigue/malaise, sleep problems/disturbances, joint and muscle pain, headaches, short-term memory loss, impaired concentration, hypersensitivity to light and sound, emotional overload, problems with dizziness and balance, recurrent flu-like symptoms, gastrointestinal problems and sensitivities to food, medications, odours or certain chemicals. It is common for patients to experience post-exertional fatigue/malaise, but the particular cluster of symptoms experienced can differ considerably from one person to another. Factors such as physical/cognitive activity, sleep, stress and mood may trigger or worsen symptoms.

In this study, variables including physical/cognitive 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, headaches, dizziness) and potential triggers of symptoms (e.g. emotional distress, dehydration) are selected by participants at the start of the study and also added to the daily questionnaires.
Intervention code [1] 312655 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307771 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] 307771 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] 308195 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] 308195 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] 352818 0
The severity of a personally-relevant symptom (e.g. body pain, headaches, tinnitus, dizziness) 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] 352818 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).

Eligibility
Key inclusion criteria
Adults 18 years or older with a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. 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
Individuals under 18 years old. Individuals who have not received a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
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
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,VIC

Funding & Sponsors
Funding source category [1] 300924 0
Self funded/Unfunded
Name [1] 300924 0
Suzanne McDonald
Address [1] 300924 0
The University of Queensland,
Centre for Clinical Research,
Building 71/918,
Royal Brisbane & Women's Hospital Campus
Herston,
Queensland,
4029
Country [1] 300924 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] 300488 0
None
Name [1] 300488 0
Address [1] 300488 0
Country [1] 300488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301696 0
The University of Queensland Medicine Faculty Low or Negligible Risk Sub-Committee
Ethics committee address [1] 301696 0
Oral Health Centre
Level 6, Oral Health Centre (883),
288 Herston Road,
Herston,
Queensland
4006
Ethics committee country [1] 301696 0
Australia
Date submitted for ethics approval [1] 301696 0
03/07/2018
Approval date [1] 301696 0
10/07/2018
Ethics approval number [1] 301696 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 ME/CFS 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 ME/CFS. 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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87806 0
Dr Suzanne McDonald
Address 87806 0
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Country 87806 0
Australia
Phone 87806 0
+61733465025
Fax 87806 0
Email 87806 0
suzanne.mcdonald@uq.edu.au
Contact person for public queries
Name 87807 0
Dr Suzanne McDonald
Address 87807 0
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Country 87807 0
Australia
Phone 87807 0
+61733465025
Fax 87807 0
Email 87807 0
suzanne.mcdonald@uq.edu.au
Contact person for scientific queries
Name 87808 0
Dr Suzanne McDonald
Address 87808 0
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Country 87808 0
Australia
Phone 87808 0
+61733465025
Fax 87808 0
Email 87808 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
By what mechanism will data be made available?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable