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Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.
After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).
And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.
The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. after SARS-CoV-2 infection | All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. |
| |
| 2. control group with negative antibody test | All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulfilling Questionaires | Other | Fulfilling Questionaires PHQ-D (brief) and FSMC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of fatigue | Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue | 6 month after infection |
| Presence of fatigue | Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue | 12 month after infection |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome. | analyzed by PHQ-D (brief) | 6 month after infection |
| Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome. |
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Inclusion Criteria:
Patient must meet ALL of the following criteria.
Exclusion Criteria:
1. Failure to give consent to the survey
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Within the FSC19-KN trial up to 250 SARS-CoV-2 positive patients and 250 volunteers without SARS-CoV-2 infection are included.
We plan to contact all attendees of the FSC19-KN trial which gave permission to contact via e-mail.
They will be asked to contribute the sub-study by declaring their informed consent online. Only if their agreement of participation is given, they can fill in our online questionnaire.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Kollum, PD Dr. | Hegau-Bodensee-Klinikum Singen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hegau Bodensee Klinikum Singen | Singen | Baden-Wurttemberg | 78224 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Sabrina Geng, Jonas Haberland, Elisabeth Haberland, Julia Hromek, Heidi Zimmermann, et al, (2024), Effects on Fatigue and Depression 11 And 19 Months after a Sars-Cov-2 Infection a Case Control Study, J. Clinical Cardiology and Cardiovascular Interventions, 7(2); DOI:10.31579/2641-0419/348 |
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The aim is to publish the results in a peer reviewed medical journal without sharing any participant data
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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analyzed by PHQ-D (brief)
| 12 month after infection |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |