COVID-19
Conditions
Brief summary
The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions.
Interventions
BEHAVIORALRehabilitation based on CBT principles
Cf. arm description
Sponsors
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fulfils pragmatic diagnostic criteria of idiopathic post-Covid syndrome: a) Confirmed acute Covid-19 by a positive PCR for SARS-CoV-2; b) Persistent symptoms at least 3 months following acute Covid-19 without symptom-free interval; c) Functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.) * Lives in one of the following Norwegian counties: Oslo, Viken, Innlandet, Vestfold og Telemark, Agder * Informed consent to participation
Exclusion criteria
* Other chronic illnesses or demanding life situations that might explain persistent symptoms and disability * Sustained organ damage (lung, heart, brain) following acute, serious Covid-19 * Bedridden * Insufficient command of Norwegian language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Functioning | Immediately after intervention (time T1) | Physical Functioning subscale from the SF-36 inventory. The SF-36 comprises a total of 36 items on subjective mental, social and physical health, which are assigned to 8 dimensions. Scale ranging from 0 (poor quality of life) to 100 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Immediately after intervention (time T1) | Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue. |
| Depression/anxiety | Immediately after intervention (time T1) | Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms. |
| Adverse effects | Immediately after intervention (time T1) | Self-invented questionnaire on adverse effects |
| Physical Functioning | At 12 months follow-up (time T2) | Physical Functioning subscale from the SF-36 inventory |
| Recovery from PIFS | Immediately after intervention (time T1) | Recovery from post-infective fatigue syndrome (PIFS) |
Countries
Norway
Outcome results
None listed