Covid-19 Long-term Revalidation Follow-up

Covid19 Clinical Trial

— Colonel  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04685629
• Other study ID #: Colonel
• Status: Withdrawn
• Start date: May 7, 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2024
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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