Clinical trial NCT04961333: Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
Official title: Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Long COVID-19
Keywords: COVID-19
rehabilitation
telemedicine
multidisciplinary
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: St Göran Hospital, Stockholm
First posted: 2021-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intervention group and waiting list control group
Primary purpose: TREATMENT

Brief summary: Internet-based multidisciplinary interventions will be offered to participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.

Detailed description: This randomised study aimed to understand if multidisciplinary internet-based interventions performed in group and individually are applicable for participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.

The participants will be randomised for treatment and waiting lists using a website random.org. Waiting list will be offered rehabilitation interventions after at least 8 weeks period of waiting to exclude a spontaneous improvement or worsening of symptoms. To understand the impact of rehabilitation on work capacity and employment/economic supply, the data from Social Insurance databas will be obtained 2021 year before and upp to 2 years after the intervention. To understand the impact of rehabilitation on sickness-leave, the data from National Insurance Agency will be obtained for 2021 and 2022.

Eligibility criteria: Inclusion Criteria:

* confirmed COVID-19 infection
* post-infection symptoms lasting longer than 3-6 months
* clinically stable persons regarding symtoms or other co-morbidities
* ability to participate in internet-based rehabilitation in group in Swedish.

Exclusion Criteria:

* uncertainty regarding covid-19 infection or co-morbidities started or exacerbated during the same time
* alcohol and drug abuse
* untreated psychiatric and somatic co-morbidities
* undergoing medical or psychotherapeutic treatment or rehabilitation which can interact with rehabilitation outcomes.

Primary outcomes:
measure: Change in health-related quality of life measured by Short Form-36
timeFrame: Investigators expect changes at 6 months follow-up after rehabilitation
measure: Changes in heart rate variability during physical tests
timeFrame: Investigators expect normalisation at 6 months follow-up
Secondary outcomes:
measure: Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders
timeFrame: Investigators expect changes already at 6 months follow-up
measure: Changed functioning and activity
timeFrame: Investigators expect normalisation at 6 months follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Göran Hospital
Study officials:
References: