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

NCT04463628 | Completed

• 1 other identifier: MUCONFIN
• Study Type: observational
• Target: 746
• Locations: 1 country
• Sites: 3

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

Conditions

Cystic Fibrosis in Children; Cystic Fibrosis

Keywords

Lockdown; Covid-19 Epidemic; questionnaire; interview

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• The reduction of each of the elements of care provision and health care utilization:

  Up to 6 months

• The change of modality of administration of antibiotic cures

  Up to 6 months

• Compliance

  Up to 6 months

• Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)

  Up to 6 months

• Presence or absence of toxic consumption (drug, alcohol) during the lockdown

  Up to 6 months

Study Arms (1)

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; Behavioral: Interview

Interventions

Questionnaire 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

Also known as: Quantitative aspect

Questionnaire and/or interview

Interview 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.

Also known as: Qualitative aspect

Questionnaire and/or interview

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Minor patient under 14 years of age
• Computer equipment or internet connection defect

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (3)

Intercommunal hospital of Créteil

Créteil, IDF, 94000, France

Location

TROUSSEAU Hospital

Paris, IDF, 75012, France

Location

FOCH Hospital

Suresnes, IDF, 92150, France

Location

Related Publications (1)

• 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.

  PMID: 36452951 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 9, 2020
• Study Start: May 15, 2020
• Primary Completion: December 30, 2021
• Study Completion: March 1, 2022
• Last Updated: August 18, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)