Covid19ColonelNCT04685629
Covid-19 Long-term Revalidation Follow-up
An observational study of Covid19, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- 25 post ICU-patients and 25 post non-ICU patients
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Males and females
- Adult age
- Hospitalization with proven Covid-19 infection with a minimum stay of 5 days
- Signed Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Covid19
- Being tested
- 25 post ICU-patients, 25 post non-ICU patients
- Keywords
- COLONEL, Tele-monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 post ICU-patientsDiagnostic test
patients who were hospitalized in an intensive care unit
25 post non-ICU patientsOther
patients who were not hospitalized in an intensive care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 8 weeks after hospital discharge
Secondary outcomes (3)
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)).
Measured: 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
Measured: 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)
Measured: 8 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 May 2020
- Primary completion22 May 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: failed to included during covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685629
- Sponsor's protocol ID
- Colonel
- Acronym
- Colonel
- Status last verified
- May 2024
- First submitted
- 21 Dec 2020
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Covid-19 Patients in Their Home Environment After Hospitalization in a Covid Department or Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04685629
- Acronym / sponsor ID
- Colonel / Colonel
- Conditions
- Covid19
- Keywords
- COLONEL, Tele-monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: failed to included during covid pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 22 May 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- Males and females
- Adult age
- Hospitalization with proven Covid-19 infection with a minimum stay of 5 days
- Signed Informed Consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25 post ICU-patientspatients who were hospitalized in an intensive care unit | Diagnostic test | – |
| 25 post non-ICU patientspatients who were not hospitalized in an intensive care unit | Other | – |
Primary outcome
Health related Quality of life (general well-being) questionnaire
Time frame: in the first 7 days after hospital discharge
Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire
Health related Quality of life (general well-being) questionnaire
Time frame: 4 weeks after hospital discharge
Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire
Health related Quality of life (general well-being) questionnaire
Time frame: 8 weeks after hospital discharge
Evaluation of Quality of Life after hospitalization due to COVID-19 infection using the EQ-5D-5L questionnaire
3 secondary outcomes
Revalidation & Reintegration
Time frame: daily, up to 8 weeks after hospital discharge
Depression and/or anxiety
Time frame: 3 times after hospital discharge: first at week 0, second time at week 4, third time 8 weeks after discharge
Post traumatic stress syndrome
Time frame: 8 weeks after hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related Quality of life (general well-being) questionnaire (time frame: in the first 7 days after hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.