Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic
- Conditions
- Cystic Fibrosis in ChildrenCystic Fibrosis
- Interventions
- Behavioral: QuestionnaireBehavioral: Interview
- Registration Number
- NCT04463628
- Lead Sponsor
- Centre Hospitalier Intercommunal Creteil
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 746
- 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
- Minor patient under 14 years of age
- Computer equipment or internet connection defect
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Questionnaire and/or interview Interview An online questionnaire to assess the quantitative aspect of the impact of lockdown on all areas of the cystic fibrosis patient's health, be it physical, mental or social (using quality of life assessment in particular and interviews in the human and social sciences). Questionnaire and/or interview Questionnaire An online questionnaire to assess the quantitative aspect of the impact of lockdown on all areas of the cystic fibrosis patient's health, be it physical, mental or social (using quality of life assessment in particular and interviews in the human and social sciences).
- Primary Outcome Measures
Name Time Method Cancellation or postponement of consultations by the health professional or patient, 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), 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, 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). 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 Outcome Measures
Name Time Method Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well) Up to 6 months Scale 0-21
Evaluation of the knowledge, experience and social representations of the risk of Covid-19 Up to 6 months Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)
Compliance Up to 6 months Questionnaire about taking or not taking treatment during confinement
Suspected and/or confirmed Covid-19 in patients with cystic fibrosis. Up to 6 months Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis
The reduction of each of the elements of care provision and health care utilization: Up to 6 months Cancellation or postponement by the patient of consultations (medical or paramedical)
* Patient cancellation of teleconsultations/telecare proposed by the health professional
* Cancellation or postponement by the patient of hospitalizations (acute or scheduled)The change of modality of administration of antibiotic cures Up to 6 months Intravenous instead of intravenous administration
Presence or absence of toxic consumption (drug, alcohol) during the lockdown Up to 6 months A questionnaire on the presence or absence of toxic consumption
Assessing the role of social inequalities in the consequences of lockdown Up to 6 months Role of social inequalities in the consequences of containment assessed by qualitative methods
Trial Locations
- Locations (3)
Intercommunal hospital of Créteil
🇫🇷Creteil, IDF, France
TROUSSEAU Hospital
🇫🇷Paris, IDF, France
FOCH Hospital
🇫🇷Suresnes, IDF, France