BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BALCoS w/o DiLCoS
Patients of the cohort that are not enrolled in the DiLCoS substudy
Intervention: Data collection (Other)
BALCoS w/ DiLCoS
Patients of the cohort that are additionnaly enrolled in the DiLCoS substudy
Intervention: Data collection (Other)
BALCoS w/ DiLCoS
Patients of the cohort that are additionnaly enrolled in the DiLCoS substudy
Intervention: Digital intervention (DiLCoS) (Other)
Outcomes
Primary Outcomes
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)
Time Frame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assesses and classifies disability due to health problems during the past 4 weeks. This study will utilize the 12- item version. Items are answered on a 5-point scale ranging from 0 = "none" to 4 = "extreme or cannot do".
Secondary Outcomes
No secondary outcomes reported