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This study is a longitudinal cohort study which investigates the effect of COVID-19 in ambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life.
This study is a longitudinal cohort study comparing two cohorts. One cohort tested positive for SARS-CoV-2 and the other tested negative for SARS-CoV-2 matched by the timing of testing in the past 6 months. Participants will be observed for two years after their test for COVID-19 with online surveys at different time intervals and face-to-face follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 | exposed cohort with a diagnosis of COVID-19 in the last 6 months |
| |
| no history of COVID-19 | non-exposed cohort without a diagnosis of COVID-19. Tested for COVID-19 because of symptoms at the same time (+/- 1 month) as the exposed cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Participants will be followed up by means of online surveys and 2 study visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue severity 6 months after diagnosis of COVID-19. | Data for this endpoint are collected with a questionnaire during the first study visit at 6 months. The severity of fatigue will be assessed using the Fatigue Severity Scale (FSS). This is a 9-item scale which measures the severity of fatigue and how it affects a person's activities and lifestyle. The score ranges from 7 to 63, with higher values indicating more fatigue. | 6 months post-COVID |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-COVID symptoms | Incidence of each individual symptoms at 6 months, 9 months, 1 year, 1.5 years and 2 years including cough, difficulty breathing, tightness on the chest, pain in the lungs, throatache, muscle ache, muscle weakness, joint pain, pain between the shoulder blades, headache, dizziness, confusion, concentration loss/lack of focus, concentration problems on short and long term, feeling absent, difficulties finding words/afasia, palpitations, hot flushes, sleeping problems, abdominal pain, blurred vision, nerve pains, sensory disorders, mood swings, anxiety, depressive feeling (Source: questionnaire during study visits and remote surveys) |
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Inclusion Criteria:
Participants eligible for inclusion in this study for the exposed cohort with a diagnosis of COVID-19 in the last 6 months must meet all of the following criteria:
Participants are sampled in the same practices as the exposed cohort and are eligible for inclusion in this study for the non-exposed without a diagnosis of COVID-19 in the last 6 months when they meet all of the following criteria:
Exclusion Criteria:
Participants eligible for the cohort with COVID-19 in the last 6 months must not meet any of the following criteria:
Participants eligible for the cohort without COVID-19 must not meet any of the following criteria:
Prior vaccination against Covid-19 is not an exclusion criterion.
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2 cohorts of people who experienced an infection in the past 6 months of which 1 group had a proven covid-19 infection and 1 group definitely did not.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Domen, MD | Contact | 016372917 | julie.domen@kuleuven.be | |
| Ann Van den Bruel, Prof MD | Contact |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| spirometry | Other | During two study visits, the lung function will be measured (FVC, FEV1) |
|
| ECG | Other | During two study visits, the presence of arrhythmia will be explored. |
|
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| 1 minute sit to stand test | Other | Physical endurance is tested during 2 study visits. |
|
| Vital parameters | Other | blood pressure, pulse, weight |
|
| 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID |
| Participants' quality of life | Euroqol EQ-5D-5L: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate a better outcome (Source: questionnaire during study visits and remote surveys) | 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID |
| Lung function (FEV1, FVC) | (Source: spirometry during study visits at 6 months and 1 year) | 6 months and 1 year post-COVID |
| The degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 (mMRC scale) | 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing | 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID |
| Gustatation | scale from 1 to 10; higher scores indicate more problems with gustation. (Source: questionnaires during study visits and remote surveys) | 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID |
| Olfaction | scale from 1 to 10; higher scores indicate more problems with olfaction. (Source: questionnaires during study visits and remote surveys) | 6 months, 9 months, 1 year, 1.5 year and 2 years post-COVID |
| Incidence of diagnoses of COPD | Source: spirometry during study visits | 6 months and 1 year post-COVID |
| Exercice capacity and endurance | Source: 1 minute sit to stand test during study visits | 6 months and 1 year post-COVID |
| Incidence of cardiovascular events including AMI, lung embolism of stroke | Questionnaire during study visits | 6 months and 1 year post-COVID |
| Number of Unplanned hospital admissions of at least 24 hours | Source: questionnaire during study visits and remote surveys | within 2 years post-COVID |
| Number of Visits to healthcare professionals | Source: questionnaire during study visits and remote surveys | within 2 years post-COVID |
| Number of days absent from work | Source: questionnaire during study visits and remote surveys | within 2 years post-COVID |
| Exploring treatments attempted by patients in the scope of post-COVID symptoms | Categorical options: no treatment; vitamines; antibiotics; puffs; pain medication; anti-inflammatory drugs; others Source: questionnaire during study visits and remote surveys | within 2 years post-COVID |
| Exploring the type of counseling patients with post-covid symptoms use. | Categorical options: no counseling; psychologist; physiotherapist; GP; rehabilitation doctor; other Source: questionnaire during study visits and remote surveys | within 2 years post-COVID |
| Exploring the meaning of fatigue post-COVID and its impact on their daily lives | Source: semi-structured interviews online | +/- 6 months post-COVID |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |