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Clinical Trials/NCT04463628
NCT04463628
Completed
Not Applicable

Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic

Centre Hospitalier Intercommunal Creteil3 sites in 1 country746 target enrollmentMay 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis in Children
Sponsor
Centre Hospitalier Intercommunal Creteil
Enrollment
746
Locations
3
Primary Endpoint
Cancellation or postponement of consultations by the health professional or patient,
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Cancellation or postponement of consultations by the health professional or patient,

Time Frame: Up to 6 months

Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),

Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),

Time Frame: Up to 6 months

Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)

Patient cancellation of teleconsultations/telecare replacement,

Time Frame: Up to 6 months

Number of consultations cancelled by the teleconsultation/replacement patient,

Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).

Time Frame: Up to 6 months

Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).

Secondary Outcomes

  • Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)(Up to 6 months)
  • Evaluation of the knowledge, experience and social representations of the risk of Covid-19(Up to 6 months)
  • Compliance(Up to 6 months)
  • Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.(Up to 6 months)
  • The reduction of each of the elements of care provision and health care utilization:(Up to 6 months)
  • The change of modality of administration of antibiotic cures(Up to 6 months)
  • Presence or absence of toxic consumption (drug, alcohol) during the lockdown(Up to 6 months)
  • Assessing the role of social inequalities in the consequences of lockdown(Up to 6 months)

Study Sites (3)

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