NCT05196451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

January 14, 2022

Last Update Submit

May 28, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Fatigue

    Immediately after intervention (time T1)

  • Fatigue

    At 12 months follow-up (time T2)

  • Depression/anxiety

    Immediately after intervention (time T1)

  • Depression/anxiety

    At 12 months follow-up (time T2)

  • Adverse effects

    Immediately after intervention (time T1)

  • +4 more secondary outcomes

Study Arms (2)

Short-time rehabilitation

ACTIVE COMPARATOR

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)

Behavioral: Rehabilitation based on CBT principles

Care as usual

NO INTERVENTION

Interventions

Rehabilitation based on CBT principlesBEHAVIORAL

Cf. arm description

Short-time rehabilitation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vegard Bratholm Wyller

Oslo, 1170, Norway

Location

Related Publications (1)

  • Nerli TF, Selvakumar J, Cvejic E, Heier I, Pedersen M, Johnsen TL, Wyller VBB. Brief Outpatient Rehabilitation Program for Post-COVID-19 Condition: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450744. doi: 10.1001/jamanetworkopen.2024.50744.

    PMID: 39699896DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Vegard B Wyller

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 19, 2022

Study Start

February 21, 2022

Primary Completion

December 1, 2023

Study Completion

April 30, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

NO(1)