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NCT05781893

Basel Long COVID-19 Cohort Study and Digital Long COVID Substudy

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

The Basel Long COVID Cohort Study (BALCoS) is a registry-based cohort study that focuses on the patients' present health status, symptoms, the course of these symptoms, and potential mechanisms involved. The project aims to investigate proposed mechanisms behind Post COVID-19 condition (PCC), including a) autoimmunity, b) chronic inflammation, c) genetics, d) coagulation disorders, and e) psychosocial factors. Patients in the cohort can also join the Digital Long COVID Study (DiLCoS), a single-arm, cohort-based proof-of-feasibility study that is part of the larger BALCoS. DiLCoS is a intervention substudy designed to evaluate whether doing exercises delivered via a smartphone app (referred as digital intervention) can help with PCC. The digital intervention is a 12-week program that includes different kinds of exercises like breathing exercises, relaxation techniques, and tips on managing fatigue and other symptoms. It also teaches patients how to monitor their activities and energy levels, and provides psychological exercises to cope with negative thoughts and pain. Patients in the cohort complete a set of assessments that include the collection of sociodemographic and clinical data, biomarkers, neurocognitive testing, psychometric questionnaires, and measures of physical performance, and provide consent that their data from routine clinical care can be used for the study.

Official title: BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-04-20

Completion Date

2026-04

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

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.

Locations (1)

University Hospital Basel, Department of Psychosomatic Medicine

Basel, Switzerland