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Making it Personal: Identifying Personalised Symptom Patterns and Triggers in Long COVID

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001319561
Enrollment
5
Registered
2024-10-31
Start date
2025-01-15
Completion date
2026-12-01
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 experience

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).

Sponsors

Southern Cross University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026