Long Term Impact of COVID-19

Study Overview
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Brief Summary
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COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has a devastating effect on human lives, including over 6.6 million death as of November 2022. Furthermore, many individuals continue to experience persisting sequelae after the initial infection. Little is known about the impact of undergoing COVID-19 hospitalisation. Hence, the investigators propose an observational longitudinal study in a cohort of COVID-19 survivors after hospital discharge, to examine their perspectives on their health, health-related quality of life, and persistence of common COVID-19 symptoms, such as fatigue, dyspnoea and anxiety. Potential influencing socio-demographic and biological factors will additionally assessed.

Official Title
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Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands

Conditions
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Long COVID-19, Post-COVID-19 Syndrome, COVID-19

Intervention / Treatment
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* Other: Observational patient reported outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages ≥18 years PCR-confirmed SARS-CoV-2 infection and hospital admission Proficiency in Dutch Providing informed consent Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 survivors<br>COVID-19 survivors: patients (≥18 years old) who were tested positive for SARS-CoV-2 infection as confirmed by polymerase-chain-reaction (PCR) testing and were subsequently hospitalised, were followed after discharge from hospitals in Enschede (MST), Hengelo or Almelo (ZGT). | Other: Observational patient reported outcomes<br>* Of COVID-19 patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health perception | measured by Short Form 36 Health Survey (SF-36) | at 12 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | measured by Short Form 36 Health Survey (SF-36) and EuroQol 5d(EQ-5D) | at 3, 6, 9 and 12 months | 
| Positive Health | measured by my Positive Health | at 3, 6, 9 and 12 months | 
| Incidence, severity and course of Fatique | measured by Short Fatique Questionnaire | at 3, 6, 9 and 12 months | 
| Incidence, severity and course of Dyspnoea | measured by modified Mental Research Council (mMRC) scale | at 3, 6, 9 and 12 months | 
| Incidence, severity and course of Sleep | measured by unvalidated single-item question | at 3, 6, 9 and 12 months | 
| Incidence, severity and course of Post-Traumatic Stress Disorder | measured by PTSD checklist for th DSM-5 (PCL-5) COVID-19 version | at 3, 6, 9 and 12 months |