Cystic Fibrosis in ChildrenMUCONFINNCT04463628
Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic
An observational study of Cystic Fibrosis in Children and Cystic Fibrosis, run by Centre Hospitalier Intercommunal Creteil at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis in Children, Cystic Fibrosis
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 746 participants
- Where
- 3 sitesFrance
- Study dates
- 15 May 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will be proposed to cystic fibrosis patients residing in France.
Who may be able to join
- 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
Who cannot join
- Minor patient under 14 years of age
- Computer equipment or internet connection defect
Trial locations and contacts
3 sites in 1 country.
France3 sites
Intercommunal hospital of Créteil
Créteil, IDF, 94000
TROUSSEAU Hospital
Paris, IDF, 75012
FOCH Hospital
Suresnes, IDF, 92150
About this study
Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
Read the 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
- Being tested
- Questionnaire, Interview
- Keywords
- Lockdown, Covid-19 Epidemic, questionnaire, interview
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Quantitative aspect
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
InterviewBehavioural
Also called Qualitative aspect
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: Up to 6 months
Patient cancellation of teleconsultations/telecare replacement,
Number of consultations cancelled by the teleconsultation/replacement patient,
Measured: 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)
Measured: 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).
Measured: Up to 6 months
Secondary outcomes (8)
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)
Measured: Up to 6 months
The change of modality of administration of antibiotic cures
Intravenous instead of intravenous administration
Measured: Up to 6 months
Compliance
Questionnaire about taking or not taking treatment during confinement
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start15 May 2020
- Primary completion30 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463628
- Sponsor's protocol ID
- MUCONFIN
- Acronym
- MUCONFIN
- Status last verified
- May 2021
- First submitted
- 29 Jun 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36452951
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04463628
- Acronym / sponsor ID
- MUCONFIN / MUCONFIN
- Conditions
- Cystic Fibrosis in Children, Cystic Fibrosis
- Keywords
- Lockdown, Covid-19 Epidemic, questionnaire, interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire and/or interview | – | Behavioral: Questionnaire, Behavioral: InterviewAn 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). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be proposed to cystic fibrosis patients residing in France.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Minor patient under 14 years of age
- Computer equipment or internet connection defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: Quantitative aspectThe 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 | Behavioural | Questionnaire and/or interview |
| InterviewAlso: Qualitative aspectTwo 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. | Behavioural | Questionnaire and/or interview |
Primary outcome
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),
Patient cancellation of teleconsultations/telecare replacement,
Time frame: Up to 6 months
Number of consultations cancelled by the teleconsultation/replacement patient,
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)
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).
8 secondary outcomes
The reduction of each of the elements of care provision and health care utilization:
Time frame: Up to 6 months
The change of modality of administration of antibiotic cures
Time frame: Up to 6 months
Compliance
Time frame: Up to 6 months
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
Presence or absence of toxic consumption (drug, alcohol) during the lockdown
Time frame: Up to 6 months
Evaluation of the knowledge, experience and social representations of the risk of Covid-19
Time frame: Up to 6 months
Assessing the role of social inequalities in the consequences of lockdown
Time frame: Up to 6 months
Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 36452951Oubaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children and Cystic Fibrosis, run by Centre Hospitalier Intercommunal Creteil at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancellation or postponement of consultations by the health professional or patient, (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.