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

NCT ID: NCT04463628

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 746 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2022-03-01

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.

Conditions

Cystic Fibrosis in Children; Cystic Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Questionnaire and/or 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

Intervention Type: BEHAVIORAL

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

Interview

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Quantitative aspect; Qualitative aspect

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Intercommunal hospital of Créteil

Créteil, IDF, France

TROUSSEAU Hospital

Paris, IDF, France

FOCH Hospital

Suresnes, IDF, France

Countries

France

References

Oubaya N, Pombet T, Delestrain C, Remus N, Douvry B, Grenet D, Corvol H, Thouvenin G, Pruliere-Escabasse V, Mounir H, Argoud D, Fretigne C, Costes L, Mackiewicz MP, Jung C, Ahamada L, Lanone S, Maitre B, Begot AC, Epaud R. Impact of the COVID-19 pandemic and associated lockdown measures on the management, health, and behavior of the cystic fibrosis population in France during 2020 (MUCONFIN). Front Public Health. 2022 Nov 14;10:978627. doi: 10.3389/fpubh.2022.978627. eCollection 2022.

Reference Type: DERIVED

PMID: 36452951 (View on PubMed)

Other Identifiers

MUCONFIN

Identifier Type: -

Identifier Source: org_study_id