COVID-19IRISNCT05013047
Impact of the COVID-19 Pandemic on the Organization of Healthcare in France
An observational study of COVID-19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 100,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 31 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: Adult patients without a symptomatic COVID-19 diagnosis, monitored for chronic disease in the French health care system.
Who may be able to join
- Patients with one of these three types of chronic diseases (Prevention Quality Indicators of the Agency for Healthcare Research and Quality): heart failure, diabetes, chronic obstructive pulmonary disease.
- All French adult patients suffering from the studied chronic diseases, covered by the Health Insurance and living in metropolitan France are included.
Who cannot join
- Patients under 18 years of age or with incomplete or inconsistent data on the "Système National des Données de Santé", or with a symptomatic COVID-19 diagnosis.
Trial locations and contacts
1 site in 1 country.
Emilie GARRIDO-PRADALIE contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Laurent BOYER, MD, +33491385266, laurent.boyer@ap-hm.fr
About this study
Official title: Impact of the Covid19 Pandemic on the Organization of Healthcare in France
The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to 2nd line facilities. Beyond the immediate impact on the management of patients infected with COVID-19, this reorganization may have reduced the capacity of management for patients requiring urgent or semi-urgent intervention, or may have postponed some necessary care. The isolation of patients at home may also have resulted in lower compliance to therapy and medical treatments and may have contributed to decompensation.
At the end of this crisis, the different organizational responses in France should be evaluated to identify the consequences and the areas for improvement in order to be prepared for future exceptional health situations. This investigation on healthcare systems confronted to an exceptional health situation thus seeks to determine if the profound reorganizations implemented during this health crisis have indirect effects on the performance of care, in particular if there is a destabilization of the care systems (emergency, semi-emergency and chronic), a loss of chance for the patients and if innovative care paths have emerged.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of pandemic COVID-19 on medication compliance in patients with chronic disease
Combined chronic drug coverage rate calculated on a three-monthly basis (average of the coverage rates for each drug)
Measured: Measured by trimesters (from March 2019 to February 2021)
Secondary outcomes (1)
Evaluate the effects of pandemic and lock-down on the risk of decompensation in patients with chronic disease.
Occurrence of at least one hospitalization for acute decompensation during each of the 6-month periods studied (exposed or not to pandemic and lock-down).
Measured: 6 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013047
- Sponsor's protocol ID
- 2021-13
- Acronym
- IRIS
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Covid19 Pandemic on the Organization of Healthcare in France
- ClinicalTrials.gov ID
- NCT05013047
- Acronym / sponsor ID
- IRIS / 2021-13
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Aug 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.
The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to 2nd line facilities. Beyond the immediate impact on the management of patients infected with COVID-19, this reorganization may have reduced the capacity of management for patients requiring urgent or semi-urgent intervention, or may have postponed some necessary care. The isolation of patients at home may also have resulted in lower compliance to therapy and medical treatments and may have contributed to decompensation.
At the end of this crisis, the different organizational responses in France should be evaluated to identify the consequences and the areas for improvement in order to be prepared for future exceptional health situations. This investigation on healthcare systems confronted to an exceptional health situation thus seeks to determine if the profound reorganizations implemented during this health crisis have indirect effects on the performance of care, in particular if there is a destabilization of the care systems (emergency, semi-emergency and chronic), a loss of chance for the patients and if innovative care paths have emerged.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients without a symptomatic COVID-19 diagnosis, monitored for chronic disease in the French health care system.
Key inclusion criteria (2 listed)
- Patients with one of these three types of chronic diseases (Prevention Quality Indicators of the Agency for Healthcare Research and Quality): heart failure, diabetes, chronic obstructive pulmonary disease.
- All French adult patients suffering from the studied chronic diseases, covered by the Health Insurance and living in metropolitan France are included.
Key exclusion criteria (1 listed)
- Patients under 18 years of age or with incomplete or inconsistent data on the "Système National des Données de Santé", or with a symptomatic COVID-19 diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the effect of pandemic COVID-19 on medication compliance in patients with chronic disease
Time frame: Measured by trimesters (from March 2019 to February 2021)
Combined chronic drug coverage rate calculated on a three-monthly basis (average of the coverage rates for each drug)
1 secondary outcome
Evaluate the effects of pandemic and lock-down on the risk of decompensation in patients with chronic disease.
Time frame: 6 months period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
Emilie GARRIDO-PRADALIE contact
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, run by Assistance Publique Hopitaux De Marseille 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 2 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent BOYER (04 91 38 75 83, laurent.boyer@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of pandemic COVID-19 on medication compliance in patients with chronic disease (time frame: Measured by trimesters (from March 2019 to February 2021)). 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 24 Aug 2021.