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

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rehabilitation based on CBT principles
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vegard Bratholm Wyller

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Short-time rehabilitation

Care as usual

Arm Description

The intervention consists of an individualized numbers of outpatient encounters (min. 2, max. 8) with medical doctors and physiotherapists at Kysthospitalet, Stavern, Norway. The encounters aim to foster a rehabilitation process based upon principles from Cognitive Behavioral Therapy (CBT)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Fatigue
Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.
Fatigue
Chalder fatigue questionnaire, total sum score
Depression/anxiety
Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.
Depression/anxiety
Hospital Anxiety and Depresssion Scale, total score
Adverse effects
Self-invented questionnaire on adverse effects
Adverse effects
Self-invented questionnaire on adverse effects
Physical Functioning
Physical Functioning subscale from the SF-36 inventory
Recovery from PIFS
Recovery from post-infective fatigue syndrome (PIFS)
Recovery from PIFS
Recovery from post-infective fatigue syndrome (PIFS)

Full Information

First Posted
January 14, 2022
Last Updated
July 18, 2023
Sponsor
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT05196451
Brief Title
Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
Acronym
SIPCOV
Official Title
Short-time Behavioural Intervention in Post-Covid Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short-time rehabilitation
Arm Type
Active Comparator
Arm Description
The intervention consists of an individualized numbers of outpatient encounters (min. 2, max. 8) with medical doctors and physiotherapists at Kysthospitalet, Stavern, Norway. The encounters aim to foster a rehabilitation process based upon principles from Cognitive Behavioral Therapy (CBT)
Arm Title
Care as usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation based on CBT principles
Intervention Description
Cf. arm description
Primary Outcome Measure Information:
Title
Physical Functioning
Description
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)
Time Frame
Immediately after intervention (time T1)
Secondary Outcome Measure Information:
Title
Fatigue
Description
Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.
Time Frame
Immediately after intervention (time T1)
Title
Fatigue
Description
Chalder fatigue questionnaire, total sum score
Time Frame
At 12 months follow-up (time T2)
Title
Depression/anxiety
Description
Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.
Time Frame
Immediately after intervention (time T1)
Title
Depression/anxiety
Description
Hospital Anxiety and Depresssion Scale, total score
Time Frame
At 12 months follow-up (time T2)
Title
Adverse effects
Description
Self-invented questionnaire on adverse effects
Time Frame
Immediately after intervention (time T1)
Title
Adverse effects
Description
Self-invented questionnaire on adverse effects
Time Frame
At 12 months follow-up (time T2)
Title
Physical Functioning
Description
Physical Functioning subscale from the SF-36 inventory
Time Frame
At 12 months follow-up (time T2)
Title
Recovery from PIFS
Description
Recovery from post-infective fatigue syndrome (PIFS)
Time Frame
Immediately after intervention (time T1)
Title
Recovery from PIFS
Description
Recovery from post-infective fatigue syndrome (PIFS)
Time Frame
At 12 months follow-up (time T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard B Wyller
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vegard Bratholm Wyller
City
Oslo
ZIP/Postal Code
1170
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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