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Concerns of Children Whose Parents Have Cystic Fibrosis (MUCOKIDS)

28. oktober 2022 opdateret af: Assistance Publique - Hôpitaux de Paris

Experiences, Expectations and Needs of Children Whose Parents Have Cystic Fibrosis - Exploratory Study

As more and more patients with cystic fibrosis (CF) become parents, we have studied parenting concerns in this serious chronic disease in a first study (MucoPar) which is ongoing.

The current study (MucoKids) is an extension of the previous MucoPar study and aims to explore and collect the perceptions, expectations and needs of children whose one parent has CF.

This will be done in the context of individual interviews or in several small groups of children led by a psychologist who will encourage them to develop what constitutes to be the child of somebody with CF.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Life expectancy has improved significantly in cystic fibrosis in recent years. From pediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. Parent patients still face the risk of complications and death while their child is still young. However, there is very little data in the literature on parenting in cystic fibrosis. In a first study which is ongoing (43 patients out of the 50 planned have been included), we intended to study parenting, considering the sick parent's point of view.

However, this question does not only concern parents and their spouses. It is also fundamental to take into account the experience of the children, to understand their experiences and their own needs in this context of serious illness of a parent with limited life expectancy.

Therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of children whose one parent has CF. Children are eligible from the age of 6 if their parents agree.

Children will have semi-structured individual interviews or will participate in focus groups with the study psychologist in order to express their feelings, difficulties, expectations and needs in living with a parent who has CF.

Thematic analysis of the content will first be done separately for individual interviews and focus groups, and a global synthesis will be carried out.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

27

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Paris, Frankrig, 75014
        • Cochin Hospital
      • Suresnes, Frankrig, 92150
        • Foch Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population is comprised of people, both minors and adults, who have a parent living with cystic fibrosis. These parents are participants in the study MUCOPAR.

Beskrivelse

Inclusion Criteria:

  • Have a parent with CF cared at one of the 2 adult CF centres participating into the study
  • Have the authorization of the parent with CF if the child is an adult and of both parents for subjects less than 18 years old
  • Be ay least 6 years old
  • Have a good level of French and good speaking skills for adolescents and adults
  • Have a level of French and oral expression skills adapted to their age group for the youngest

Exclusion Criteria:

  • Psychiatric pathology (borderline state, bipolarity and other psychotic disorders) in their parents or themselves
  • Serious somatic disease not related to cystic fibrosis in their parents or themselves

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Focus groups
Children aged 8 years or more participating in a focus group with the study psychologist
Adfærdsmæssigt: Focus groups
Groups of 3 to 8 children led by the study psychologist lasting 1 hour for the 8-11-year-old children and up to 2 hours for the children of at least 12 years old, about being the child of a parent with CF
Adfærdsmæssigt: Individual interviews
Interview led by the psychologist about being the child of a parent with CF
Individual interviews
All children who have an individual interview with the study psychologist
Adfærdsmæssigt: Focus groups
Groups of 3 to 8 children led by the study psychologist lasting 1 hour for the 8-11-year-old children and up to 2 hours for the children of at least 12 years old, about being the child of a parent with CF
Adfærdsmæssigt: Individual interviews
Interview led by the psychologist about being the child of a parent with CF

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identification of themes about being the child of a parent with CF
Tidsramme: 2 years
Content of groups and individual interviews analysed by thematic analysis
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of themes
Tidsramme: 2 years
The number of appearances of each theme, in focus groups and in individual interviews will provide information on the importance of each theme.
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Samarbejdspartnere

Grégory Lemarchal Association

Efterforskere

  • Studiestol: Cécile FLAHAULT, PhD, Assistance Publique - Hôpitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. februar 2021

Primær færdiggørelse (Faktiske)

18. februar 2022

Studieafslutning (Faktiske)

18. februar 2022

Datoer for studieregistrering

Først indsendt

7. januar 2021

Først indsendt, der opfyldte QC-kriterier

7. januar 2021

Først opslået (Faktiske)

8. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APHP190326

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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