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Covid-19 Long-term Revalidation Follow-up

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04685629
Acronym
Colonel
Enrollment
0
Registered
2020-12-28
Start date
2020-05-07
Completion date
2022-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COLONEL, Tele-monitoring

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.

Interventions

DIAGNOSTIC_TEST25 post ICU-patients

patients who were hospitalized in an intensive care unit

OTHER25 post non-ICU patients

patients who were not hospitalized in an intensive care unit

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health related Quality of life (general well-being) questionnairein the first 7 days after hospital dischargeEvaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire

Secondary

MeasureTime frameDescription
Revalidation & Reintegrationdaily, up to 8 weeks after hospital dischargeEvaluation 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)).
Depression and/or anxiety3 times after hospital discharge: first at week 0, second time at week 4, third time 8 weeks after dischargeEvaluation of depression and anxiety of the patient after hospitalization via the HADS (Hospital Anxiety and Depression Scale) questionnaire
Post traumatic stress syndrome8 weeks after hospital dischargeEvaluation of post traumatic stress syndrome of the patient after hospitalization via the PTSS questionnaire (of Erik De Soir)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026