COVID-19, Post-hospitalization, Disease ImpactPRO-COVIDNCT04912804
Perceived Health After Hospitalization for COVID-19
An observational study of COVID-19, Post-hospitalization, Disease Impact, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Post-hospitalization, Disease Impact
- What is being tested?
- Questionnaires
- How many people
- 207 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 22 May 2021
- 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: Patient with COVID-19 discharged from a conventional short-stay hospital ward.
Who may be able to join
- Adult patient
- Patient with a diagnosis of COVID-19 confirmed by PCR and/or CT scan
- Patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a COVID-19 infection
- Patient providing oral consent to participate in the study
- Patient able to understand and answer the questionnaires used
- Patient able to answer the questions on an electronic device and to receive requests by email and/or SMS
- Patient who has electronic equipment at home and an Internet subscription allowing him/her to answer the questionnaires online
Who cannot join
- Patient under guardianship, curatorship or a measure of judicial safeguard
Trial locations and contacts
1 site in 1 country.
About this study
There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks
- Being tested
- Questionnaires
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
SF-12, GHQ-12 and HAQ
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Patient | Patient discharged from a conventional short-stay hospitalization unit. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease
Measured: Through study completion, an average of 6 months
The value of perceived health scores in patients who achieved PASS and MCII
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start30 Jun 2020
- Primary completion22 May 2021
- Study completion22 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19, Post-hospitalization, Disease ImpactStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912804
- Sponsor's protocol ID
- DEVILLIERS AOIc 2020
- Acronym
- PRO-COVID
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 15 Apr 2022
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Health After Hospitalization for COVID-19
- ClinicalTrials.gov ID
- NCT04912804
- Acronym / sponsor ID
- PRO-COVID / DEVILLIERS AOIc 2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 22 May 2021 (actual)
- First posted
- 3 Jun 2021 (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.
There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Patient | – | Other: QuestionnairesPatient discharged from a conventional short-stay hospitalization unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with COVID-19 discharged from a conventional short-stay hospital ward.
Key inclusion criteria (7 listed)
- Adult patient
- Patient with a diagnosis of COVID-19 confirmed by PCR and/or CT scan
- Patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a COVID-19 infection
- Patient providing oral consent to participate in the study
- Patient able to understand and answer the questionnaires used
Key exclusion criteria (1 listed)
- Patient under guardianship, curatorship or a measure of judicial safeguard
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 |
|---|---|---|
| QuestionnairesSF-12, GHQ-12 and HAQ | Other | COVID-19 Patient |
Primary outcome
Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease
Time frame: Through study completion, an average of 6 months
The value of perceived health scores in patients who achieved PASS and MCII
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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 COVID-19, Post-hospitalization, Disease Impact, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 15 Apr 2022. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease (time frame: Through study completion, an average of 6 months). The study lists 2 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 15 Apr 2022.