Clinical trial NCT06085911: RCT Long COVID-19 Rehabilitation
Official title: Intervention Against Long COVID in Norway - Systematic Rehabilitation. A Randomised Pilot and Feasibility Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Post-Acute COVID-19 Syndrome
Post-Infectious Disorders
Keywords: Rehabilitation
Long COVID
Clinical trial
Telemedicine
Inflammation
Post-Acute COVID-19 Syndrome
COVID-19
Post-Infectious Disorders
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Oslo University Hospital
name: Norwegian University of Science and Technology
First posted: 2023-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial (RCT) comparing two intervention groups
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom reduction
timeFrame: 3 months
Secondary outcomes:
measure: Symptoms grouped by systems reduction
timeFrame: 12 month follow-up
measure: Graded symptom reduction
timeFrame: 3-12 months
measure: Work improvement
timeFrame: 3-12 months
measure: Quality of life improvement
timeFrame: 3-12 months
measure: Neuropsychological functions improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Maja Wilhelmsen, ph.d
role: PRINCIPAL_INVESTIGATOR
References: