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Covid-19 Long-term Revalidation Follow-up (Colonel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04685629
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: 25 post ICU-patients Other: 25 post non-ICU patients

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up of Covid-19 Patients in Their Home Environment After Hospitalization in a Covid Department or Intensive Care Unit
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : May 22, 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Health related Quality of life (general well-being) questionnaire [ Time Frame: in the first 7 days after hospital discharge ]
    Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire

  2. Health related Quality of life (general well-being) questionnaire [ Time Frame: 4 weeks after hospital discharge ]
    Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire

  3. Health related Quality of life (general well-being) questionnaire [ Time Frame: 8 weeks after hospital discharge ]
    Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire


Secondary Outcome Measures :
  1. Revalidation & Reintegration [ Time Frame: daily, up to 8 weeks after hospital discharge ]
    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)).

  2. Depression and/or anxiety [ Time Frame: 3 times after hospital discharge: first at week 0, second time at week 4, third time 8 weeks after discharge ]
    Evaluation of depression and anxiety of the patient after hospitalization via the HADS (Hospital Anxiety and Depression Scale) questionnaire

  3. Post traumatic stress syndrome [ Time Frame: 8 weeks after hospital discharge ]
    Evaluation of post traumatic stress syndrome of the patient after hospitalization via the PTSS questionnaire (of Erik De Soir)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We want to follow up 50 patients from hospital discharge, where we want to distinguish 2 groups:

  • patients after admission to the intensive care unit (25)
  • patients without admission to the intensive care unit (25)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685629


Contacts
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Contact: Guy Hans, Prof 03 821 49 45 Guy.Hans@uza.be
Contact: Johanna Kwakkel-Vanerp, Prof. johanna.kwakkel-vanerp@uza.be

Locations
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Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerpen, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
More Information
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Responsible Party: Davina Wildemeersch, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04685629    
Other Study ID Numbers: Colonel
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Davina Wildemeersch, University Hospital, Antwerp:
COLONEL
Tele-monitoring
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases