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

N/ACompletedNCT05196451

University Hospital, Akershus314 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

314

Conditions

COVID-19

Interventions

Rehabilitation based on CBT principlesBEHAVIORAL

Cf. arm description

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Vegard Bratholm Wyller

Oslo, Norway

Outcomes

Primary Outcomes

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)

Time frame: Immediately after intervention (time T1)

Secondary Outcomes

Fatigue

Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue.

Time frame: Immediately after intervention (time T1)

Fatigue

Chalder fatigue questionnaire, total sum score

Time frame: At 12 months follow-up (time T2)

Depression/anxiety

Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms.

Time frame: Immediately after intervention (time T1)

Depression/anxiety

Hospital Anxiety and Depresssion Scale, total score

Time frame: At 12 months follow-up (time T2)

Adverse effects

Self-invented questionnaire on adverse effects

Time frame: Immediately after intervention (time T1)

Adverse effects

Self-invented questionnaire on adverse effects

Time frame: At 12 months follow-up (time T2)

Physical Functioning

Physical Functioning subscale from the SF-36 inventory

Data from ClinicalTrials.gov

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