Covid-19 Long-term Revalidation Follow-up

Withdrawn

• Conditions: Covid19

• Registration Number: NCT04685629
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-07
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-28
• Primary Completion: 2022-05-22
• Study Completion: 2022-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health related Quality of life (general well-being) questionnaire	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

Name	Time	Method
Depression and/or anxiety	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
Revalidation & Reintegration	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)).
Post traumatic stress syndrome	8 weeks after hospital discharge	Evaluation of post traumatic stress syndrome of the patient after hospitalization via the PTSS questionnaire (of Erik De Soir)

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerpen, Belgium