Clinical trial NCT05781893: Basel Long COVID-19 Cohort Study and Digital Long COVID Substudy
Official title: BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post COVID-19 Condition (PCC)
Keywords: Coronavirus disease (COVID)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Somatic Symptom Disorder (SSD)
fatigue
shortness of breath
cognitive dysfunction
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: State Secretariat for Education Research and Innovation, Switzerland
name: European Union's Horizon Europe research and innovation programme
First posted: 2023-03-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited at the medical outpatient clinic unit at the UHB from April 2023 on. Any patient fulfilling inclusion criteria and lacking exclusion criteria will be asked to participate in the study and the substudy.

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.


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

Primary outcomes:
measure: Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
Secondary outcomes:
Other outcomes:
measure: Change in Visual analogue scales (VAS)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in EuroHIS Quality-of-Life-8 (QOL-8)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Somatic Symptom Disorder Questionnaire (SSD-12)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Patient Health Questionnaire (PHQ-15)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Resilience Scale (Resilience Scale (RS-11)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Chalder Fatigue Scale
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in the Perceived Stress Scale (PSS)
timeFrame: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)
measure: Change in JAMAR® grip strength test on the dominant hand
timeFrame: At Baseline and T3 (BL + 12 months)
measure: Change in 6-minute walking test
timeFrame: At Baseline and T3 (BL + 12 months)
measure: Change in one minute sit-to-stand test (STS-60)
timeFrame: At Baseline and T3 (BL + 12 months)
measure: Change in neurocognitive status of patients assessed by CNS Vital Signs (CNSVS) test
timeFrame: At Baseline and T3 (BL + 12 months); approximately 40-50 minutes per test battery
measure: (Only BALCoS w/ DiLCoS) Progress and patients' engagement assessed by weekly feedback questions
timeFrame: After BL and before T1; at day 6 in weeks 1-11
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Psychosomatic Medicine
Study officials:
affiliation: University Hospital Basel, Department of Psychosomatic Medicine
name: Gunther Meinlschmidt
role: PRINCIPAL_INVESTIGATOR
References: