COVID Rehabilitation

Sponsor
University Hospital of North Norway (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06085911
Collaborator
University of Bergen (Other), Oslo University Hospital (Other), Norwegian University of Science and Technology (Other)
60
2
24

Study Details

Study Description

Brief Summary

The Coronavirus 2019 (COVID-19) pandemic has resulted in at least four million infections in Norway. The vast majority of cases are diagnosed and followed up in the community, but some with extensive symptoms and large degree of reduced function are referred to regional Covid-clinics. In total this patient group is placing an enormous burden on the already over stretched health care services. As the pandemic subsides the emerging threat of long-term disability from COVID remains to be quantified. Brain fog and cognitive symptoms are common in long COVID in 30% of mild infections resulting in sick leave and loss of daily function, with women overrepresented among long COVID sufferers. The true prevalence and underlying mechanisms of long COVID remains to be quantified. Although vaccination prevents severe infection and death, we have little knowledge on how best to rehabilitate those who suffers from long COVID.

Here we propose to develop knowledge on treatment interventions to counteract disability from long COVID and lessening the burden on health care services. We will conduct a study of where we compare a short group intervention with systematic personalised neurocognitive rehabilitation to document symptom alleviation. Our overarching goal is to develop effective programmes for this evolving disease to reduce the suffering for the patients, and thereby reducing costs for health services and society at large.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: One day course
  • Behavioral: Individual follow-ups
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trial (RCT) comparing two intervention groupsrandomized controlled trial (RCT) comparing two intervention groups
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intervention Against Long COVID in Norway - Systematic Rehabilitation. A Randomised Pilot and Feasibility Study.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: individual follow-ups

tailored individual follow-up rehabilitation program with home-based exercises

Behavioral: Individual follow-ups
the patient will meet a therapist in a physical consultation at the Covid rehabilitation clinic lasting for 1.5 hours. Together they will in detail map out symptoms and impairment of function in the patient's life. Together the patient and the therapist will create plan to address these problems consisting of tailored home-based exercises within the three focus areas. Tree follow-up consultations will be given.

Active Comparator: a one-day course.

a one-day course.

Behavioral: One day course
a physical one-day course at the Covid rehabilitation clinic. During these six hours, general information about rehabilitation principals will be given. Theory about three 15 focus areas of importance will be presented; daily routine, importance of being active and cognitive training. They will meet others with similar problems and will be given an opportunity to exchange experience. 8-10 patients will participate in the group.

Outcome Measures

Primary Outcome Measures

  1. Symptom reduction [3 months]

    A reduction in number present symptoms is evaluated in each patient group. A significant greater alleviation in the of number symptoms at three months is considered as a better prognosis.

Secondary Outcome Measures

  1. Symptoms grouped by systems reduction [12 month follow-up]

    All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neurocognitive symptoms) and as full recovery (absence of all symptoms) at 3-, 6- and 12 months.

  2. Graded symptom reduction [3-12 months]

    Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of neurocognitive relevant symptoms and dyspnea.

  3. Work improvement [3-12 months]

    Improvement in work participation

  4. Quality of life improvement [3-12 months]

    Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)

  5. Neuropsychological functions improvement [6 months]

    Improvement of neuropsychological functions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Symptoms attributable to long COVID according to WHO definition [14] that affect their daily activities

  • Positive Covid test; a home-test, PCR test or serology.

  • Neurocognitive symptoms

  • Age between 18 and 65 years

  • Participant is able and willing to provide informed consent

Exclusion Criteria:
  • Patients that do not want to comply to planned physical study visits

  • Patients who are unable to complete surveys in Norwegian

  • Patients with known chronic neurocognitive disease before Covid-19 or other diseases that can explain current symptoms

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital of North Norway
  • University of Bergen
  • Oslo University Hospital
  • Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Maja Wilhelmsen, ph.d, University Hospital of North Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT06085911
Other Study ID Numbers:
  • 587293
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital of North Norway
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023