Rehabilitation and Return to Everyday Life for Patients With Long COVID

NCT06544382 | Active Not Recruiting

• 1 other identifier: Long COVID rehabilitation
• Study Type: observational
• Target: 914
• Locations: 1 country
• Sites: 1

Brief Summary

This non-randomised controlled trial will investigate if patients with long COVID receiving a structured and group-based rehabilitation intervention (The Long COVID Rehabilitation Intervention) will report a difference in mean change in self-reported mental fatigue measured by Mental Fatigue Scale and will report a mean difference in weeks of sick-leave obtained through the Danish Register for Evaluation of Marginalisation compared to usual practise over a 12-month follow-up period. Alongside the effectiveness evaluation, a economic evaluation study and process evaluation study will be conducted, Patients from Aarhus Municipality, Central Denmark Region, Denmark, receive The Long COVID Rehabilitation Intervention and will be allocated to the intervention group. Patients receiving rehabilitation in the other municipalities of Central Denmark Region, Denmark, will be allocated to the control group. Alongside this, a health economic study and a process evaluation study will be conducted.

Conditions

Long COVID

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (2)

• The degree of mental fatigue measured with The Mental Fatigue Scale

  The Mental Fatigue Scale measures the degree of mental fatigue through 15 questions covering affective, cognitive and sensory symptoms along with duration of sleep and daytime variation in symptom severity with a total score of 0-40. Higher score indicates higher degree of mental fatigue.

  At inclusion and 12-month follow-up

• Number of weeks of sick leave obtained through the Danish Register for Evaluation of Marginalisation

  The Danish Register for Evaluation of Marginalisation is a national register containing information on the Danish population. Sick leave is automatically registered when a person receives sick leave allowances.

  From inclusion to 12-month follow-up

Secondary Outcomes (2)

• Health related quality of life estimated with the European Quality of Life - 5 Dimensions 5 Levels (EQ-5D-5L)

  At inclusion and 12-month follow-up

• Disability estimated using The Post-COVID-19 Functional Status Scale

  At inclusion and 12-month follow-up

Study Arms (2)

Intervention group

Patients from Aarhus Municipality, Central Denmark Region, Denmark, receiving The Long COVID Rehabilitation Intervention.

Other: The Long COVID Rehabilitation Intervention

Control group

Patients from the other municipalities of Central Denmark Region, Denmark, receiving a less structured rehabilitation programme with individual session and few group options with patients with long COVID or mixed diagnoses.

Other: Usual care

Interventions

The Long COVID Rehabilitation Intervention OTHER

The intervention is a structured rehabilitation intervention with a duration of minimum 3 months comprising 4-12 individual sessions and 1-4 group-based courses delivered by physiotherapists and occupational therapists.

Intervention group

Usual care OTHER

A less structured rehabilitation programme comprising individual session with a few group options with patients with long COVID or mixed diagnoses.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with long COVID examined at the Post-COVID-19 Clinic at Aarhus University Hospital and assessed at the Department of Physiotherapy and Occupational Therapy have been invited to participate in the project from July 2020 to June 2023. The patients are recruited to the study during their appointment at the Department of Physiotherapy and Occupational Therapy at Aarhus University Hospital for an examination of their functioning due to their long COVID symptoms. Thus, the inclusion of the patients is integrated into and carried out in clinical practise.

You may qualify if:

• The patients should be diagnosed with long COVID and assessed at the Post-COVID-19 Clinic at Aarhus University
• The patients should be examined at the Department of Physiotherapy and Occupational Therapy and referred to rehabilitation in their municipality of residence
• The patients should be aged ≥ 18 years old
• The patients should be residing in one of the 19 municipalities of Central Denmark Region
• The patients should be referred to rehabilitation in their municipality of residence
• The patients should give informed written consent to participate in the study

You may not qualify if:

• The patient is unable to give written informed consent (e.g. due to language barriers)
• The patient is resided outside of Central Denmark Region, Denmark

Sponsors & Collaborators

• Defactum, Central Denmark Region: lead
• Aarhus University Hospital: collaborator
• VIA University College: collaborator
• University of Aarhus: collaborator
• Aarhus Municipality, Denmark: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Oestergaard Gregersen, PhD

  DEFACTUM, Central Denmark Region, and Department of Public Health, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: November 23, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

DK (1)