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Clinical Trials/NCT06085911
NCT06085911UnknownNot Applicable

Intervention Against Long COVID in Norway - Systematic Rehabilitation. A Randomised Pilot and Feasibility Study.

University Hospital of North Norway1 site in 1 country60 target enrollmentStarted: November 3, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Symptom reduction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

individual follow-ups

Experimental

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

Intervention: Individual follow-ups (Behavioral)

a one-day course.

Active Comparator

a one-day course.

Intervention: One day course (Behavioral)

Outcomes

Primary Outcomes

Symptom reduction

Time Frame: 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 Outcomes

  • Graded symptom reduction(3-12 months)
  • Work improvement(3-12 months)
  • Neuropsychological functions improvement(6 months)
  • Symptoms grouped by systems reduction(12 month follow-up)
  • Quality of life improvement(3-12 months)

Investigators

Sponsor
University Hospital of North Norway
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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