Reducing frequency and severity of post-exertional malaise in people with long COVID. Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
250 participants with long COVID will be randomised into intervention and control groups using a secure, independent online trial allocation service. Allocation will be stratified for age and sex.
Sponsors
University of the West of Scotland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults reporting persistent symptoms which have lasted for at least 8 weeks after initial infection with COVID-19 and which interfere with day-to-day activity. 2. Participants should be recovering at home and have access to an Android (SDK16 or higher) or iPhone (iOS version 10 or higher) mobile phone.
Exclusion criteria
Exclusion criteria: 1. Currently receiving ongoing care for LC via primary or secondary care services. 2. Prior diagnosis with a comorbidity with similar symptoms (e.g. ME/CFS). 3. Currently receiving a therapy known to cause exacerbations. 4. Currently participating in another LC focussed intervention. 5. Impaired cognitive function which compromises comprehension of study information or messaging. 6. Insufficient English language for messaging to be effective. 7. No mobile phone access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 13/02/2025: Post-exertional malaise using the DSQ-PEM at baseline and 6 months _____ Previous primary outcome measure as of 05/04/2024: Post-exertional malaise using the PEM questionnaire at baseline and 6 months _____ Previous primary outcome measure as of 07/03/2023: Physical functioning assessed via the SF-36 at baseline and 6 months _____ Previous primary outcome measure: Post-exertional malaise using the PEM questionnaire at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/04/2024: 1. PEM trend using PEM questionnaire assessed monthly 2. Depression trend using PHQ-9 monthly 3. Depression change using PHq-9 assessed at baseline and 6 months 4. Fatigue trend using FSS monthly 5. Fatigue change using FSS at baseline and 6 months 6. Quality of life trend using SF12 monthly 7. Quality of life change using SF12 at baseline and 6 months 8. Self-efficacy trend using Self Efficacy Scale monthly 9. Cognitive function using a variation of the symbol digit modalities test monthly 10. Cognitive function using a variation of the symbol digit modalities test at baseline and 6 months. 11. Pain using Pain VAS assessed at baseline and 6 months 12. Pain trend using Pain VAS assessed monthly between months 0-6 13. Resting heart rate assessed daily using the activity tracker _____ Previous secondary outcome measures: 1. PEM trend using PEM questionnaire assessed monthly 2. Depression trend using PHQ-9 monthy 3. Depression change using PHq-9 assessed at baseline and 6 months 4. Fatigue trend using FSS monthly 5. Fatigue change using FSS at baseline and 6 months 6. Quality of life trend using SF36 monthly 7. Quality of life change using SF36 at baseline and 6 months 8. Self-efficacy trend using Self Efficacy Scale monthly 9. Cognitive function using a variation of the symbol digit modalities test monthly 10. Cognitive function using a variation of the symbol digit modalities test at baseline and 6 months. 11. Pain using Pain VAS assessed at baseline and 6 months 12. Pain trend using Pain VAS assessed monthly between months 0-6 13. Resting heart rate assessed daily using the activity tracker | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactNicholas;Lawrence Sculthorpe;Hayes
;
Outcome results
None listed