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Trial registered on ANZCTR
Registration number
ACTRN12624001319561
Ethics application status
Approved
Date submitted
15/10/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Making it Personal: Identifying Personalised Symptom Patterns and Triggers in Long COVID
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Scientific title
Making it Personal: Identifying Personalised Symptom Patterns and Triggers in Long COVID adult participants using N-of-1 Observational Studies: A Feasibility and Acceptability Study
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Secondary ID [1]
313195
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Long COVID
335265
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Condition category
Condition code
Infection
331834
331834
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0
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Long COVID is a heterogenous condition with >50 different clinical symptoms affecting 10 different body systems (Décary et al., 2021). Definitions of long COVID vary, but the most common definition is when a person who has had COVID-19 experiences symptoms for >12 weeks. Many people with long COVID report experiencing post-exertional malaise (PEM), which is a marked exacerbation of 1 or more symptoms in response to physical or cognitive exertion. The specific constellation of symptoms experienced by people with long COVID differs from one individual to another. Factors such as sleep, stress and physical activity may exacerbate symptoms.
This study involves a series of N-of-1 observational studies. No intervention will be applied. In this study, participants will complete brief questionnaire items about symptoms and potential triggers (e.g. physical activity, sleep, stress, mood) on a daily basis for a period of 6 weeks via a wrist worn electronic diary device with an inbuilt accelerometer ('PRO-Diary'). Fatigue will be measured as the primary clinical outcome measure because it represents the most commonly experienced symptom of long COVID. Questionnaire items related to personally-relevant symptoms (e.g. body pain) and potential symptom triggers will be selected by participants at the start of the study and incorporated into to the design of the daily questionnaires. Participants will complete the brief questionnaires three times per day (morning, afternoon and evening) and they will take approximately 1-2 minutes to complete. Participants will be given the option to extend their participation for a further 6 weeks (12 weeks in total).
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Intervention code [1]
329593
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Not applicable
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Diary completion rate
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Assessment method [1]
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Diary completion rate will be assessed by calculating the ratio of the number of diary entries completed by each participant to the total number of expected entries, expressed as a percentage.
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Timepoint [1]
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The diary completion rate will be assessed for each individual at the end of the 6 week data collection period and again after any additional data collection if the participant has agreed extended their data collection period (up to a maximum of 6 additional weeks).
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Primary outcome [2]
339456
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Fatigue severity (primary clinical outcome).
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Assessment method [2]
339456
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Fatigue severity will be assessed daily using a visual analogue scale ranging from 0 to 100.
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Timepoint [2]
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Three times per day (morning, afternoon and evening) for a minimum of 6 weeks and maximum of 12 weeks (the duration of the data collection period will be based on the preference of the participant).
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Secondary outcome [1]
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Recruitment rate.
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Assessment method [1]
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The recruitment rate will be assessed by calculating the ratio of the number of participants successfully recruited divided by the number of eligible participants approached, expressed as a percentage.
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Timepoint [1]
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The recruitment rate will be assessed at the end of the study, once all participants have completed their N-of-1 study.
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Secondary outcome [2]
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Retention rate.
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Assessment method [2]
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The retention rate will be assessed by calculating the ratio of the number of participants who complete the study divided by the number of participants recruited, expressed as a percentage.
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Timepoint [2]
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The retention rate will be assessed at the end of the study, once all participants have completed their N-of-1 study.
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Secondary outcome [3]
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Extension rate.
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Assessment method [3]
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The extension rate will be assessed by the number of participants opting to extend their data collection period divided by the total number of participants, expressed as a percentage.
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Timepoint [3]
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The extension rate will be assessed at the end of the study once all participants have completed their N-of-1 study.
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Secondary outcome [4]
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Extension length
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Assessment method [4]
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The length of the extension for each participant will also be recorded by calculating the number of days of data the participant has provided beyond the initial 6 week data collection period.
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Timepoint [4]
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The length of the extension will be assessed at the end of the study once all participants have completed their N-of-1 study.
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Secondary outcome [5]
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Personalised symptom severity (secondary clinical outcome).
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Assessment method [5]
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Personally relevant long COVID symptoms that have been selected by the participant at the start of the study will be assessed daily using a visual analogue scale ranging from 0 to 100.
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Timepoint [5]
440049
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Personally relevant long COVID symptoms will be assessed three times per day (morning, afternoon and evening) for a minimum of 6 weeks and maximum of 12 weeks (the duration of the data collection period will be based on the preference of the participant).
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Secondary outcome [6]
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Participants' views on their experience of participation in the study.
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Assessment method [6]
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Participants' views on their experience of participation will be assessed through a post-study semi-structured interview. The qualitative data from these interviews will be analysed thematically to evaluate participants’ perspectives on the acceptability of the study procedures.
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Timepoint [6]
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Participant's views on their experience will be assessed at the end of the study once all participants have completed their post-study interview.
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Eligibility
Key inclusion criteria
- Aged 18 years or older
- Lives in greater Brisbane
- Has access to the internet to complete online questionnaires
- Is willing to complete brief questionnaires via an electronic diary each day for 6 weeks
- Individual has been diagnosed with long COVID by a medical practitioner
- Individual experiences fatigue, reports that this symptom is associated with their long COVID diagnosis, and it is in the moderate to severe range as indicated by a score of 22 or greater on the Fatigue Assessment Scale.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Individual currently has COVID-19.
- Individual has received a clinical diagnosis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS).
- Individual is experiencing a sleep disorder as indicated by a score of 31 or above on the Global Sleep Assessment Questionnaire.
- Individual has cognitive impairment as indicated by a score of 4 or above on the Six-Item Screener.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Statistical power in N-of-1 observational 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 required to be recruited.
Individual- and group-level analyses will be performed, using Bayesian time series models and Bayesian hierarchical models, respectively.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/11/2024
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Actual
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Date of last participant enrolment
Anticipated
17/02/2025
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Actual
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Date of last data collection
Anticipated
4/04/2025
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
317482
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University
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Name [1]
317482
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Southern Cross University
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Address [1]
317482
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Country [1]
317482
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Australia
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Primary sponsor type
University
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Name
Southern Cross University
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Address
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Country
Australia
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Secondary sponsor category [1]
319776
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None
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Name [1]
319776
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Address [1]
319776
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Country [1]
319776
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316196
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Southern Cross University Human Research Ethics Committee
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Ethics committee address [1]
316196
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https://www.scu.edu.au/research/research-excellence/research-ethics/
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Ethics committee country [1]
316196
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Australia
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Date submitted for ethics approval [1]
316196
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17/06/2024
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Approval date [1]
316196
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15/10/2024
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Ethics approval number [1]
316196
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2024/148
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Summary
Brief summary
This study aims to evaluate the feasibility and acceptability of using innovative patient-centred N-of-1 observational studies to identify personalised symptom patterns and triggers in individuals with long COVID. A series of N-of-1 observational studies with 10 participants will be conducted. Participants will complete brief questionnaires rating their symptoms and potential triggers three times daily for a period of 6 to 12 weeks using an electronic diary. They will receive highly personalised feedback about their data at the end of the study. Participants will be invited to discuss their experience of participation in the study during a post-study semi-structured interview.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Suzanne McDonald
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Address
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Southern Cross University, Locked Mail Bag 4, Coolangatta QLD 4225 Australia
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Country
137102
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Australia
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Phone
137102
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+61 0494 055 188
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Fax
137102
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Email
137102
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[email protected]
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Contact person for public queries
Name
137103
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Suzanne McDonald
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Address
137103
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Southern Cross Univesity, Locked Mail Bag 4, Coolangatta QLD 4225 Australia
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Country
137103
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Australia
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Phone
137103
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+61 0494 055 188
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Fax
137103
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Email
137103
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[email protected]
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Contact person for scientific queries
Name
137104
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Suzanne McDonald
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Address
137104
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Southern Cross University, Locked Mail Bag 4, Coolangatta QLD 4225 Australia
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Country
137104
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Australia
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Phone
137104
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+61 0494 055 188
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Fax
137104
0
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Email
137104
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Only researchers who provide a methodologically sound proposal to the chief investigator.
Conditions for requesting access:
•
-
What individual participant data might be shared?
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Data collected for participants underlying published results will be made available in a de-identified format.
What types of analyses could be done with individual participant data?
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For individual participant data meta-analyses.
When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication; no end date.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
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Access is subject to approval by chief investigator (Dr Suzanne McDonald;
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
Approval 2024_148.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF