Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 313195 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID 335265 0
Condition category
Condition code
Infection 331834 331834 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 329593 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339455 0
Diary completion rate
Timepoint [1] 339455 0
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).
Primary outcome [2] 339456 0
Fatigue severity (primary clinical outcome).
Timepoint [2] 339456 0
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).
Secondary outcome [1] 440045 0
Recruitment rate.
Timepoint [1] 440045 0
The recruitment rate will be assessed at the end of the study, once all participants have completed their N-of-1 study.
Secondary outcome [2] 440046 0
Retention rate.
Timepoint [2] 440046 0
The retention rate will be assessed at the end of the study, once all participants have completed their N-of-1 study.
Secondary outcome [3] 440047 0
Extension rate.
Timepoint [3] 440047 0
The extension rate will be assessed at the end of the study once all participants have completed their N-of-1 study.
Secondary outcome [4] 440048 0
Extension length
Timepoint [4] 440048 0
The length of the extension will be assessed at the end of the study once all participants have completed their N-of-1 study.
Secondary outcome [5] 440049 0
Personalised symptom severity (secondary clinical outcome).
Timepoint [5] 440049 0
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).
Secondary outcome [6] 440950 0
Participants' views on their experience of participation in the study.
Timepoint [6] 440950 0
Participant's views on their experience will be assessed at the end of the study once all participants have completed their post-study interview.

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.

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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
17/02/2025
Actual
Date of last data collection
Anticipated
4/04/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317482 0
University
Name [1] 317482 0
Southern Cross University
Country [1] 317482 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 319776 0
None
Name [1] 319776 0
Address [1] 319776 0
Country [1] 319776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316196 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 316196 0
Ethics committee country [1] 316196 0
Australia
Date submitted for ethics approval [1] 316196 0
17/06/2024
Approval date [1] 316196 0
15/10/2024
Ethics approval number [1] 316196 0
2024/148

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

Contacts
Principal investigator
Name 137102 0
Dr Suzanne McDonald
Address 137102 0
Southern Cross University, Locked Mail Bag 4, Coolangatta QLD 4225 Australia
Country 137102 0
Australia
Phone 137102 0
+61 0494 055 188
Fax 137102 0
Email 137102 0
[email protected]
Contact person for public queries
Name 137103 0
Suzanne McDonald
Address 137103 0
Southern Cross Univesity, Locked Mail Bag 4, Coolangatta QLD 4225 Australia
Country 137103 0
Australia
Phone 137103 0
+61 0494 055 188
Fax 137103 0
Email 137103 0
[email protected]
Contact person for scientific queries
Name 137104 0
Suzanne McDonald
Address 137104 0
Southern Cross University, Locked Mail Bag 4, Coolangatta QLD 4225 Australia
Country 137104 0
Australia
Phone 137104 0
+61 0494 055 188
Fax 137104 0
Email 137104 0
[email protected]

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:
• Only researchers who provide a methodologically sound proposal to the chief investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• 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?
• 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:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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?

TypeCitationLinkEmailOther DetailsAttachment
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.