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Completed

NCT Number: 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

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

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Key information

Conditions

Cystic Fibrosis in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intercommunal hospital of Créteil, Créteil, IDF, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Quantitative aspect

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.

Other names: Qualitative aspect

Primary outcomes

  1. Cancellation or postponement of consultations by the health professional or patient,

    Time frame: Up to 6 months

    Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),

  2. Patient cancellation of teleconsultations/telecare replacement,

    Time frame: Up to 6 months

    Number of consultations cancelled by the teleconsultation/replacement patient,

  3. Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),

    Time frame: Up to 6 months

    Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)

  4. Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).

    Time frame: Up to 6 months

    Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).

Secondary outcomes

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

    Time frame: Up to 6 months

    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)

  2. The change of modality of administration of antibiotic cures

    Time frame: Up to 6 months

    Intravenous instead of intravenous administration

  3. Compliance

    Time frame: Up to 6 months

    Questionnaire about taking or not taking treatment during confinement

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

    Time frame: Up to 6 months

    Scale 0-21

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

    Time frame: Up to 6 months

    A questionnaire on the presence or absence of toxic consumption

  6. Evaluation of the knowledge, experience and social representations of the risk of Covid-19

    Time frame: Up to 6 months

    Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)

  7. Assessing the role of social inequalities in the consequences of lockdown

    Time frame: Up to 6 months

    Role of social inequalities in the consequences of containment assessed by qualitative methods

  8. Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.

    Time frame: Up to 6 months

    Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: MUCONFIN

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 9, 2020
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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