SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers (SAFETIM-needs)
27. mars 2020 oppdatert av: University Hospital, Grenoble
SAFETIM Besoins: Suivi Des Adolescents Des Familles et Des Equipes Pour Une Transition Idéale en Mucoviscidose Etude Des Besoins Adolescents et Parent Avant après Transition
prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Adolescent's and parent's needs will be studied, before the transition and their experiences of transition, in order to propose organizational national recommendations semi structured interview with adolescents and parents separately, before and after transition.
semi structured interviews will be conducted twice for each (adolescent and parents), the first in the 6 months before transition and the second in the 6 months after transition.
After their verbatims will be analyzed and the optimal organisation will be determined for the transition based according to their point of view.
At the end, the data from this study will be matched with data collected in a former study from care givers practices during transition in the french CF centers.
Studietype
Observasjonsmessig
Registrering (Faktiske)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Clermont-Ferrand, Frankrike, 63003
- University Hospital, Clermont-Ferrand
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Grenoble, Frankrike, 38043
- UniversityHospitalGrenoble
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Lyon, Frankrike, 69322
- Hôpital Femme Mère Enfant, HCL
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Pierre Bénite, Frankrike, 69495
- South Hospital of Lyon, HCL
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
17 år til 23 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews their age will be between 17 and 23 years old.
living followed in one of the 3 CF center
Beskrivelse
Inclusion Criteria:
- CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews
Exclusion Criteria:
- none
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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CF patient and parents cohort in 3 CF center
All adolescents for whom the transition to the adult center is scheduled within six months and their parent will be interviewed before and after transition.
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Before and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center.
And every interview will be transcribed by an other person
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Identify CF adolescents and their parents needs before transition
Tidsramme: During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.
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Qualitative analysis of interviews
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During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.
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Identify CF adolescents and their parents experience after transition
Tidsramme: During their systematic appointment at the CF center, patients will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed.
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Qualitative analysis of interviews
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During their systematic appointment at the CF center, patients will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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What do they need, to feel safe before transition
Tidsramme: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed
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Identify patients and parents needs
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During their systematic appointment at the CF center, patients and parents will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed
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Do these needs of CFadolescent and their parents taken into account in the transition procedures
Tidsramme: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed
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Do the procedures take into account the needs of patients and parents
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During their systematic appointment at the CF center, patients and parents will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed
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Which factors influence quality of transition other than TPE dimension.
Tidsramme: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
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Satisfaction level of Patients and Family After Transition
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Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
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Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
Tidsramme: comparison between the results with health care practices one year after the last interview will be performed
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Identifying key points of the patient's personalized transition, the timing and personalization of the health care course during the transition
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comparison between the results with health care practices one year after the last interview will be performed
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: LLERENA catherine, MD, CHU GA Grenobe France
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
- Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6. doi: 10.1016/1054-139x(93)90143-d. No abstract available.
- Bregnballe V, Schiotz PO, Lomborg K. Parenting adolescents with cystic fibrosis: the adolescents' and young adults' perspectives. Patient Prefer Adherence. 2011;5:563-70. doi: 10.2147/PPA.S25870. Epub 2011 Nov 7.
- Kreindler JL, Miller VA. Cystic fibrosis: addressing the transition from pediatric to adult-oriented health care. Patient Prefer Adherence. 2013 Dec 11;7:1221-6. doi: 10.2147/PPA.S37710.
- Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 10.1542/peds.2014-1909. Epub 2014 Oct 6.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. juni 2017
Primær fullføring (Faktiske)
31. desember 2018
Studiet fullført (Faktiske)
31. desember 2018
Datoer for studieregistrering
Først innsendt
1. august 2017
Først innsendt som oppfylte QC-kriteriene
26. september 2017
Først lagt ut (Faktiske)
2. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 38RC17.005
- 2017-A00062-51 (Annen identifikator: ID RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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