SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers (SAFETIM-needs)
27 mars 2020 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
50
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Clermont-Ferrand, France, 63003
- University Hospital, Clermont-Ferrand
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Grenoble, France, 38043
- UniversityHospitalGrenoble
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Lyon, France, 69322
- Hôpital Femme Mère Enfant, HCL
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Pierre Bénite, France, 69495
- South Hospital of Lyon, HCL
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
17 ans à 23 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Identify CF adolescents and their parents needs before transition
Délai: 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
Délai: 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.
|
Qualitative analysis of interviews
|
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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
What do they need, to feel safe before transition
Délai: 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
Délai: 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.
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: LLERENA catherine, MD, CHU GA Grenobe France
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 juin 2017
Achèvement primaire (Réel)
31 décembre 2018
Achèvement de l'étude (Réel)
31 décembre 2018
Dates d'inscription aux études
Première soumission
1 août 2017
Première soumission répondant aux critères de contrôle qualité
26 septembre 2017
Première publication (Réel)
2 octobre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mars 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 38RC17.005
- 2017-A00062-51 (Autre identifiant: ID RCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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