Covid-19 Long-term Revalidation Follow-up

Study Overview
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Brief Summary
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In this monocentric, prospective and descriptive trial we want to evaluate the long-term consequences for patients treated for Covid-19. Covid patients who were hospitalized for min. 5 days either in a Covid-19 department or in intensive care unit will be followed-up for 8 weeks after hospital discharge. This is done via an innovative electronic platform in the home environment (UZA@home). On the one hand the quality of life, rehabilitation and reintegration of the patient will be evaluated and on the other hand the patient will be screened for various psychosocial aspects such as anxiety, depression and post-traumatic stress syndrome.

Official Title
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Long-term Follow-up of Covid-19 Patients in Their Home Environment After Hospitalization in a Covid Department or Intensive Care Unit

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: 25 post ICU-patients
* Other: 25 post non-ICU patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Adult age Hospitalization with proven Covid-19 infection with a minimum stay of 5 days Signed Informed Consent Exclusion Criteria: The patient does not have a smartphone or computer with internet connection.The patient is not sufficiently skilled in entering data via a digital interface. This degree of skill is estimated by the research doctor or nurse. Patient in a palliative setting (DNR 2 or higher outside of COVID condition The patient does not speak the Dutch language

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: 25 post ICU-patients|patients who were hospitalized in an intensive care unit|
|Other: 25 post non-ICU patients|patients who were not hospitalized in an intensive care unit|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of life (general well-being) questionnaire | Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire | in the first 7 days after hospital discharge | 
| Health related Quality of life (general well-being) questionnaire | Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire | 4 weeks after hospital discharge | 
| Health related Quality of life (general well-being) questionnaire | Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire | 8 weeks after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revalidation & Reintegration | Evaluation of revalidation of the patient after hospitalization (daily functioning and mobilization via a daily diary and objective measurements by means of remote monitoring techniques (saturation measurement, activity tracker, sleep monitor)). | daily, up to 8 weeks after hospital discharge | 
| Depression and/or anxiety | Evaluation of depression and anxiety of the patient after hospitalization via the HADS (Hospital Anxiety and Depression Scale) questionnaire | 3 times after hospital discharge: first at week 0, second time at week 4, third time 8 weeks after discharge | 
| Post traumatic stress syndrome | Evaluation of post traumatic stress syndrome of the patient after hospitalization via the PTSS questionnaire (of Erik De Soir) | 8 weeks after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COLONEL, Tele-monitoring