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

Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Cystic Fibrosis in Children
• Intervention / Treatment: Behavioral: Questionnaire; Behavioral: Interview

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.

• Study Type: Observational
• Enrollment (Actual): 746

Contacts and Locations

Study Locations

• France
  • IDF
    • Creteil, IDF, France, 94000
      • intercommunal hospital of Créteil
    • Paris, IDF, France, 75012
      • Trousseau Hospital
    • Suresnes, IDF, France, 92150
      • Foch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will be proposed to cystic fibrosis patients residing in France.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

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; Other Names: Quantitative aspect; 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.; Other Names: Qualitative aspect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient cancellation of teleconsultations/telecare replacement,	Number of consultations cancelled by the teleconsultation/replacement patient,	Up to 6 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The change of modality of administration of antibiotic cures	Intravenous instead of intravenous administration	Up to 6 months
Compliance	Questionnaire about taking or not taking treatment during confinement	Up to 6 months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2020
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (ACTUAL): July 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: questionnaire; Lockdown; interview; Covid-19 Epidemic
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; COVID-19; Cystic Fibrosis
• Other Study ID Numbers: MUCONFIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No