Official Title
BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy
Brief Summary

The Basel Long COVID Cohort Study (BALCoS) is a registry-based cohort study that focuseson the patients' present health status, symptoms, the course of these symptoms, andpotential mechanisms involved. The project aims to investigate proposed mechanisms behindPost COVID-19 condition (PCC), including a) autoimmunity, b) chronic inflammation, c)genetics, d) coagulation disorders, and e) psychosocial factors. Patients in the cohortcan also join the Digital Long COVID Study (DiLCoS). This substudy evaluates whetherdoing exercises delivered via a smartphone app (referred as digital intervention) canhelp with PCC. The digital intervention is a 12-week program that includes differentkinds of exercises like breathing exercises, relaxation techniques, and tips on managingfatigue and other symptoms. It also teaches patients how to monitor their activities andenergy levels, and provides psychological exercises to cope with negative thoughts andpain. Patients in the cohort complete a set of assessments that include the collection ofsociodemographic and clinical data, biomarkers, neurocognitive testing, psychometricquestionnaires, and measures of physical performance, and provide consent that their datafrom routine clinical care can be used for the study.

Detailed Description

Not Provided

Recruiting
Post COVID-19 Condition (PCC)

Other: Digital intervention (DiLCoS)

The DiLCoS substudy comprises a digital intervention. A smartphone app is used to provide
the patient with a 12-week exercise program, including physical elements (in the form of
breathing exercises, relief positions and relaxation techniques), psychoeducational
elements (e.g., information about fatigue, neurocognitive symptoms, media consumption,
healthy diet), self-monitoring elements (activity planning, energy management), and
psychological elements (e.g., guided exercises to improve acceptance of current
situation, cognitive distancing from negative thoughts, imagination techniques for pain
management). It holds promise for significantly improving the management and quality of
life of individuals living with PCC.

Other: Data collection

Data collection on sociodemography, clinical data (retrieved from regular care for PCC in
the UHB medical outpatient clinic), biomarkers derived from blood samples, neurocognitive
testing, psychometric questionnaires, and measures of physical performance.

Eligibility Criteria

Inclusion Criteria:

- Patients diagnosed with PCC will be included. PCC will be defined as:

- History of confirmed or suspected SARS CoV-2 infection

- Symptoms usually start within 3 months from the onset of acute SARS CoV-2 infection
with symptoms and effects that last for at least 2 months

- Symptoms cannot be explained by an alternative diagnosis

- signed informed consent is required

Additional Inclusion Criteria for participtation in DiLCoS:

- A smartphone with a compartible-operating system

- Separate signed informed consent is required

Exclusion Criteria:

- Age <18 years

- Lack of consent to participate in the study

- Language barriers (lack of sufficient knowledge of German)

- Lack of general understanding of study procedures

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Switzerland
Locations

University Hospital Basel, Department of Psychosomatic Medicine
Basel, Switzerland

Investigator: Gunther Meinlschmidt, Prof.
gunther.meinlschmidt@unibas.ch

Contacts

Gunther Meinlschmidt, Prof.
+41 61 328 63 10
gunther.meinlschmidt@unibas.ch

Rebekka Schnepper, Dr.
+41 61 328 46 33
rebekka.schnepper@usb.ch

Gunther Meinlschmidt, Principal Investigator
University Hospital Basel, Department of Psychosomatic Medicine

University Hospital, Basel, Switzerland
NCT Number
Keywords
Coronavirus disease (COVID)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Somatic Symptom Disorder (SSD)
Fatigue
Shortness of Breath
cognitive dysfunction
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome