Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial

Not Applicable

Completed

• Conditions: COVID-19

• Registration Number: NCT05196451
• Lead Sponsor: University Hospital, Akershus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-19
• Study Start: 2022-02-21
• Primary Completion: 2023-12-01
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fatigue	At 12 months follow-up (time T2)	Chalder fatigue questionnaire, total sum score
Depression/anxiety	At 12 months follow-up (time T2)	Hospital Anxiety and Depresssion Scale, total score
Physical Functioning	At 12 months follow-up (time T2)	Physical Functioning subscale from the SF-36 inventory
Recovery from PIFS	At 12 months follow-up (time T2)	Recovery from post-infective fatigue syndrome (PIFS)
Adverse effects	At 12 months follow-up (time T2)	Self-invented questionnaire on adverse effects

Trial Locations

Locations (1)

Vegard Bratholm Wyller; 🇳🇴 Oslo, Norway