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

Cystic Fibrosis Clinical Trial

— MUCONFIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463628
• Other study ID #: MUCONFIN
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: March 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Intercommunal hospital of Créteil	Creteil	IDF
France	TROUSSEAU Hospital	Paris	IDF
France	FOCH Hospital	Suresnes	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancellation or postponement of consultations by the health professional or patient,	Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),	Up to 6 months
Primary	Patient cancellation of teleconsultations/telecare replacement,	Number of consultations cancelled by the teleconsultation/replacement patient,	Up to 6 months
Primary	Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),	Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)	Up to 6 months
Primary	Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).	Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).	Up to 6 months
Secondary	The reduction of each of the elements of care provision and health care utilization:	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)	Up to 6 months
Secondary	The change of modality of administration of antibiotic cures	Intravenous instead of intravenous administration	Up to 6 months
Secondary	Compliance	Questionnaire about taking or not taking treatment during confinement	Up to 6 months
Secondary	Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)	Scale 0-21	Up to 6 months
Secondary	Presence or absence of toxic consumption (drug, alcohol) during the lockdown	A questionnaire on the presence or absence of toxic consumption	Up to 6 months
Secondary	Evaluation of the knowledge, experience and social representations of the risk of Covid-19	Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)	Up to 6 months
Secondary	Assessing the role of social inequalities in the consequences of lockdown	Role of social inequalities in the consequences of containment assessed by qualitative methods	Up to 6 months
Secondary	Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.	Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis	Up to 6 months