SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers (SAFETIM-needs)
27 de marzo de 2020 actualizado por: 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
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Clermont-Ferrand, Francia, 63003
- University Hospital, Clermont-Ferrand
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Grenoble, Francia, 38043
- UniversityHospitalGrenoble
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Lyon, Francia, 69322
- Hôpital Femme Mère Enfant, HCL
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Pierre Bénite, Francia, 69495
- South Hospital of Lyon, HCL
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
17 años a 23 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Identify CF adolescents and their parents needs before transition
Periodo de tiempo: 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.
|
|
Identify CF adolescents and their parents experience after transition
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
What do they need, to feel safe before transition
Periodo de tiempo: 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
|
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
|
|
Do these needs of CFadolescent and their parents taken into account in the transition procedures
Periodo de tiempo: 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
|
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
|
|
Which factors influence quality of transition other than TPE dimension.
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: LLERENA catherine, MD, CHU GA Grenobe France
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de junio de 2017
Finalización primaria (Actual)
31 de diciembre de 2018
Finalización del estudio (Actual)
31 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
1 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
26 de septiembre de 2017
Publicado por primera vez (Actual)
2 de octubre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
27 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 38RC17.005
- 2017-A00062-51 (Otro identificador: ID RCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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