Clinical trial NCT04463628: Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic
Official title: Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis in Children
Cystic Fibrosis
Keywords: Lockdown
Covid-19 Epidemic
questionnaire
interview
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 746
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be proposed to cystic fibrosis patients residing in France.

Brief summary: Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

Detailed description: The containment of the population in France is a health measure implemented in response to SARS-CoV-2 (Covid-19) infection. For cystic fibrosis, as for many chronic diseases, this disruption is twofold. On the one hand, it affects daily life due to the closure of schools and the introduction of national lockdown, but also the hospital, which has profoundly changed its procedures, which are almost completely focused on the care of patients with Covid-19. This forced transformation was at the expense of its usual role including the management of chronic diseases such as cystic fibrosis. It has an impact on patients' consultations cancelled, rescheduled or replaced by teleconsultations, hospitalisations whether scheduled or during acute exacerbations which are more complicated to organise. Access to treatments is also more difficult (physiotherapy), which can affect compliance. Confinement also profoundly changes the lives of our patients. It changes the way individuals can apprehend their disease and its integration into their everyday life, studies or professional projects. Finally, it is the confrontation with a potentially fatal infection that reminds us of the risks and consequences of a potentially severe chronic disease.

Eligibility criteria: Inclusion Criteria:

* Patient with cystic fibrosis (Southern Chlorine \> 60 mEq/L and/or presence of 2 pathogenic mutations on the CFTR gene)
* Supported in a French CRCM (Cystic fibrosis Resource and Competence Center)
* Affiliated to a social security scheme
* Non-opposition for participation in the protocol

Exclusion Criteria:

* Minor patient under 14 years of age
* Computer equipment or internet connection defect

Primary outcomes:
measure: Cancellation or postponement of consultations by the health professional or patient,
timeFrame: Up to 6 months
measure: Patient cancellation of teleconsultations/telecare replacement,
timeFrame: Up to 6 months
measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),
timeFrame: Up to 6 months
measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).
timeFrame: Up to 6 months
Secondary outcomes:
measure: The reduction of each of the elements of care provision and health care utilization:
timeFrame: Up to 6 months
measure: The change of modality of administration of antibiotic cures
timeFrame: Up to 6 months
measure: Compliance
timeFrame: Up to 6 months
measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)
timeFrame: Up to 6 months
measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown
timeFrame: Up to 6 months
measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19
timeFrame: Up to 6 months
measure: Assessing the role of social inequalities in the consequences of lockdown
timeFrame: Up to 6 months
measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Creteil
country: France
facility: Intercommunal hospital of Créteil
state: IDF
city: Paris
country: France
facility: TROUSSEAU Hospital
state: IDF
city: Suresnes
country: France
facility: FOCH Hospital
state: IDF
Study officials:
References: