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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 746 (actual)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cystic Fibrosis in Children
• Cystic Fibrosis

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaire	The study questionnaire was constructed as follows: * One part is composed of validated questionnaires: Cystic fibrosis specific self-questionnaire for quality of life, questionnaire for screening for anxiety disorder. * The other part, which was not validated, was constructed as follows: questionnaire on knowledge of Covid-19 adapted to the new exceptional situation (Covid-19 pandemic) and specific questions adapted to the research objective on Covid-19 from the questionnaire of the French Public Health survey, to monitor changes in behaviour and mental health during lockdown
BEHAVIORAL	Interview	Two interviews in the human and social sciences, conducted by recorded video-conference, will be proposed to 15 patients during and after the lockdown.Two interviews will take place: one during the lockdown and one at 6 months from the first interview (or at the end of the confinement if it lasts more than 6 months). The interviews will be conducted independently of the results of the questionnaire.

Timeline

• Start date: 2020-05-15
• Primary completion: 2021-12-30
• Completion: 2022-03-01
• First posted: 2020-07-09
• Last updated: 2022-08-18

Locations

3 sites across 1 country: France