CClinicalTrials.gg
Status unknownNCT05013047IRISUpdated Aug 24, 2021

Impact of the COVID-19 Pandemic on the Organization of Healthcare in France

An observational study in COVID-19, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100,000
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients without a symptomatic COVID-19 diagnosis, monitored for chronic disease in the French health care system.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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).

    Time frame: 6 months period

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Study locations

1 of 1 sites recruiting
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13354, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05013047
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 19, 2021
Start date
Jul 1, 2020
Primary completion
Jul 1, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 24, 2021

Study contacts

Laurent BOYER
Contact
laurent.boyer@ap-hm.fr
04 91 38 75 83
Emilie GARRIDO-PRADALIE
Contact
Emilie.GARRIDO-PRADALIE@ap-hm.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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