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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: 25 post ICU-patients; Other: 25 post non-ICU patients

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Estimated): May 22, 2022
• Study Completion (Estimated): December 1, 2022

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Tele-monitoring; COLONEL
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Colonel

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No