Covid-19 Long-term Revalidation Follow-up

NCT04685629 | Withdrawn

• 1 other identifier: Colonel
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COLONEL; Tele-monitoring

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Revalidation & Reintegration

  daily, up to 8 weeks after hospital discharge

• Depression and/or anxiety

  3 times after hospital discharge: first at week 0, second time at week 4, third time 8 weeks after discharge

• Post traumatic stress syndrome

  8 weeks after hospital discharge

Interventions

25 post ICU-patients DIAGNOSTIC_TEST

patients who were hospitalized in an intensive care unit

25 post non-ICU patients OTHER

patients who were not hospitalized in an intensive care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Males and females
• Adult age
• Hospitalization with proven Covid-19 infection with a minimum stay of 5 days
• Signed Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 28, 2020
• Study Start: May 7, 2020
• Primary Completion: May 22, 2022
• Study Completion: December 1, 2022
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

BE (1)