RCT Long COVID-19 Rehabilitation

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

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 Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation; Post-Acute COVID-19 Syndrome; Post-Infectious Disorders
• Intervention / Treatment: Behavioral: Individual follow-ups; Behavioral: One day course

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maja Wilhelmsen, MD, Ph.d; Phone Number: +4777627834; Email: maja.wilhelmsen@unn.no
• Study Contact Backup: Name: Synne Garner Pedersen, ph.d; Phone Number: +4791838630; Email: Synne.Garder.Pedersen@unn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom reduction	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms grouped by systems reduction	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.	12 month follow-up
Graded symptom reduction	Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of neurocognitive relevant symptoms and dyspnea.	3-12 months
Work improvement	Improvement in work participation	3-12 months
Quality of life improvement	Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)	3-12 months
Neuropsychological functions improvement	Improvement of neuropsychological functions	6 months

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Oslo University Hospital; University of Bergen; Norwegian University of Science and Technology
• Investigators: Principal Investigator: Maja Wilhelmsen, ph.d, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Inflammation; Telemedicine; COVID-19; Clinical trial; Long COVID; Post-Acute COVID-19 Syndrome; Post-Infectious Disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; COVID-19; Infections; Communicable Diseases; Post-Acute COVID-19 Syndrome; Post-Infectious Disorders
• Other Study ID Numbers: 587293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No