COVID-19COVAMBUNCT05684575
Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy
A study testing Phone satisfaction questionnaire in people with COVID-19, run by Hôpital NOVO at 2 sites in France.
Trial summary
The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, or private providers. This organization coordinates the care to be implemented at home based on the city/hospital link. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Phone satisfaction questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2023to 25 Apr 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients over 18 years of age
- Patients with virologically proven COVID 19 (positive Polymerase Chain Reaction or antigenic test) or based on clinical and radiological evidence
- Patients discharged from hospital or from the emergency room on oxygen between 1 and 5L at the time of discharge
- Organization of discharge by a service provider (PRADO or private)
Who cannot join
- Patients discharged from the intensive care unit
- Oxygen-requiring patients > 5 Liters
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise
Beaumont-sur-Oise, 95260
Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise
Pontoise, 95300
About this study
Official title: Early Return of COVID-19 Patients to Home on Oxygen: Evaluation of a New Strategy Based on the City/hospital Link
The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, or private providers. This organization coordinates the care to be implemented at home based on the city/hospital link. The coordinator of this organization was also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge.
The aim of this study is to evaluate this new organization, both in terms of its impact on patient outcomes (survival and re-hospitalization rates) and on patients' experiences and satisfaction with their care.
Read the detailed description
The COVID-19 pandemic was responsible for an unprecedented hospital tension with multiple consequences (medical, economic, social...). The first scientific responses were found with unprecedented speed. Very quickly, innovative solutions and a complete reorganization of the health system were necessary to manage this crisis. In order to limit the number of patients hospitalized and/or the length of their hospitalization, most hospitals quickly set up systems to organize the early return of patients to their homes on oxygen. Studies evaluating telemedicine as a tool for monitoring oxygen-requiring patients at home have shown that it is effective and safe for monitoring these patients. Another retrospective study estimated the 30-day rehospitalization rate for patients with SARS-CoV-2 pneumonia after return home on oxygen with telephone monitoring by a nurse to be 8.5% (95% confidence interval, 6.2%-10.7%) and all-cause mortality to be 1.3% (95% confidence interval, 0.6%-2.5%).
The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, and a private provider. These organizations coordinate the care to be implemented at home based on the city/hospital link (oxygen provider, private nurse for the injection of anticoagulants and sometimes insulin and monitoring of vital parameters). These organizations were also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge, with the attending physician or, failing that, in the infectious diseases department of the Pontoise Hospital.
- Conditions
- COVID-19
- Being tested
- Phone satisfaction questionnaire
- Keywords
- COVID-19, Oxygen therapy, Early return
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone satisfaction questionnaireOther
Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Phone satisfaction questionnaire | Other | Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy Receives: Other: Phone satisfaction questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the evolution of patients with COVID-19 who benefited from an early return home on oxygen organized by the PRADO or a private provider
Assessment of mortality (all causes) at 30 days of hospital discharge (D30) : number of died patients
Measured: At 30 days of hospital discharge (D30)
Secondary outcomes (2)
Assessment of the risk of early re-hospitalization of patients following their return home
Number of re-hospitalizations at 7 days from hospital discharge (D7)
Measured: At 7 days from hospital discharge (D7)
Assessment of patients' satisfaction with their care and return home
Evaluation of patients'satisfaction :
Satisfaction questionnaire contains 5 questions :
For Q1, patient answer : Very satisfied, Satisfied, Neither satisfied or unsatisfied, Unsatisfied or Very unsatisfied For Q2, patient answer : Very confident, Confident, Neither confident or anguished, Anguished or Very anguished For Q3, patient answer : Yes, I don't know or No For Q4 and Q5, patient answer : Yes or No
Measured: At the end of the study, an average of 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start6 Feb 2023
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Celeste Lambert, Principal investigator, Hospital René Dubos Pontoise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684575
- Sponsor's protocol ID
- CHRD1921
- Acronym
- COVAMBU
- Status last verified
- May 2023
- First submitted
- 12 Jan 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Return of COVID-19 Patients to Home on Oxygen: Evaluation of a New Strategy Based on the City/hospital Link
- ClinicalTrials.gov ID
- NCT05684575
- Acronym / sponsor ID
- COVAMBU / CHRD1921
- Conditions
- COVID-19
- Keywords
- COVID-19, Oxygen therapy, Early return
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 13 Jan 2023 (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.
The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, or private providers. This organization coordinates the care to be implemented at home based on the city/hospital link. The coordinator of this organization was also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge.
The aim of this study is to evaluate this new organization, both in terms of its impact on patient outcomes (survival and re-hospitalization rates) and on patients' experiences and satisfaction with their care.
Detailed description
The COVID-19 pandemic was responsible for an unprecedented hospital tension with multiple consequences (medical, economic, social...). The first scientific responses were found with unprecedented speed. Very quickly, innovative solutions and a complete reorganization of the health system were necessary to manage this crisis. In order to limit the number of patients hospitalized and/or the length of their hospitalization, most hospitals quickly set up systems to organize the early return of patients to their homes on oxygen. Studies evaluating telemedicine as a tool for monitoring oxygen-requiring patients at home have shown that it is effective and safe for monitoring these patients. Another retrospective study estimated the 30-day rehospitalization rate for patients with SARS-CoV-2 pneumonia after return home on oxygen with telephone monitoring by a nurse to be 8.5% (95% confidence interval, 6.2%-10.7%) and all-cause mortality to be 1.3% (95% confidence interval, 0.6%-2.5%).
The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, and a private provider. These organizations coordinate the care to be implemented at home based on the city/hospital link (oxygen provider, private nurse for the injection of anticoagulants and sometimes insulin and monitoring of vital parameters). These organizations were also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge, with the attending physician or, failing that, in the infectious diseases department of the Pontoise Hospital.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone satisfaction questionnaire | Other | Other: Phone satisfaction questionnaireEvaluation of the outcome of Covid-19 patients discharged home on oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age
Key exclusion criteria (2 listed)
- Patients discharged from the intensive care unit
- Oxygen-requiring patients > 5 Liters
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 |
|---|---|---|
| Phone satisfaction questionnaireEvaluation of the outcome of Covid-19 patients discharged home on oxygen therapy | Other | Phone satisfaction questionnaire |
Primary outcome
Description of the evolution of patients with COVID-19 who benefited from an early return home on oxygen organized by the PRADO or a private provider
Time frame: At 30 days of hospital discharge (D30)
Assessment of mortality (all causes) at 30 days of hospital discharge (D30) : number of died patients
2 secondary outcomes
Assessment of the risk of early re-hospitalization of patients following their return home
Time frame: At 7 days from hospital discharge (D7)
Assessment of patients' satisfaction with their care and return home
Time frame: At the end of the study, an average of 10 month
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Dr Celeste Lambert principal investigator
Hospital René Dubos Pontoise
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone satisfaction questionnaire in people with COVID-19, run by Hôpital NOVO at 2 sites 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 4 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Description of the evolution of patients with COVID-19 who benefited from an early return home on oxygen organized by the PRADO or a private provider (time frame: At 30 days of hospital discharge (D30)). 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 19 Sep 2024.