Post-Acute COVID-19 Syndrome, Post-Infectious Disorders, Rehabilitation
Conditions
Keywords
Rehabilitation, Long COVID, Clinical trial, Telemedicine, Inflammation, Post-Acute COVID-19 Syndrome, COVID-19, Post-Infectious Disorders
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.
Interventions
BEHAVIORALOne 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.
BEHAVIORALIndividual 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.
Sponsors
University of Bergen
Oslo University Hospital
Norwegian University of Science and Technology
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled trial (RCT) comparing two intervention groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Work improvement | 3-12 months | Improvement in work participation |
| 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) |
| Neuropsychological functions improvement | 6 months | Improvement of neuropsychological functions |
Countries
Norway
Contacts
Primary ContactMaja Wilhelmsen, MD, Ph.d
Backup ContactSynne G Pedersen, ph.d
Outcome results
None listed