Rehabilitation and Return to Everyday Life for Patients With Long COVID
NCT Number: NCT06544382
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Long COVID
Interventions: OTHER: The Long COVID Rehabilitation Intervention|OTHER: Usual care
Sponsor: Defactum, Central Denmark Region
Collaborators: Aarhus University Hospital|VIA University College|University of Aarhus|Aarhus Municipality
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 914
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-11-23
Completion Date: 2026-08-31
Locations: Aarhus University Hospital, Aarhus, 8200, Denmark

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.

Primary Outcome Measures: 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 Outcome Measures: Health related quality of life estimated with the European Quality of Life - 5 Dimensions 5 Levels (EQ-5D-5L), EQ-5D-5L is a self-assessed, health related, quality of life questionnaire measuring quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort and anxiety/depression., At inclusion and 12-month follow-up|Disability estimated using The Post-COVID-19 Functional Status Scale, The Post-COVID-19 Functional Status Scale is an ordinal scale with six steps covering grade 0 (no functional limitations), grade 1 (negligible functional limitations), grade 2 (slight functional limitations), grade 3 (moderate functional limitations), grade 4 (severe functional limitations and grade 5 (death)., At inclusion and 12-month follow-up