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

COVID-19 Clinical Trial

— SIPCOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05196451
• Other study ID #: 21/12248
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: April 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Syndrome

Intervention

Behavioral:
• Rehabilitation based on CBT principles
Cf. arm description

Locations

Country	Name	City	State
Norway	Vegard Bratholm Wyller	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Functioning	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)	Immediately after intervention (time T1)
Secondary	Fatigue	Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.	Immediately after intervention (time T1)
Secondary	Fatigue	Chalder fatigue questionnaire, total sum score	At 12 months follow-up (time T2)
Secondary	Depression/anxiety	Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.	Immediately after intervention (time T1)
Secondary	Depression/anxiety	Hospital Anxiety and Depresssion Scale, total score	At 12 months follow-up (time T2)
Secondary	Adverse effects	Self-invented questionnaire on adverse effects	Immediately after intervention (time T1)
Secondary	Adverse effects	Self-invented questionnaire on adverse effects	At 12 months follow-up (time T2)
Secondary	Physical Functioning	Physical Functioning subscale from the SF-36 inventory	At 12 months follow-up (time T2)
Secondary	Recovery from PIFS	Recovery from post-infective fatigue syndrome (PIFS)	Immediately after intervention (time T1)
Secondary	Recovery from PIFS	Recovery from post-infective fatigue syndrome (PIFS)	At 12 months follow-up (time T2)