- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03298685
SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers (SAFETIM-needs)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Clermont-Ferrand, Frankrike, 63003
- University Hospital, Clermont-Ferrand
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Identify CF adolescents and their parents needs before transition
Tidsram: 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.
|
Qualitative analysis of interviews
|
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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
What do they need, to feel safe before transition
Tidsram: 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
|
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
Tidsram: 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
|
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.
Tidsram: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
|
Satisfaction level of Patients and Family After Transition
|
Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
|
Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
Tidsram: comparison between the results with health care practices one year after the last interview will be performed
|
Identifying key points of the patient's personalized transition, the timing and personalization of the health care course during the transition
|
comparison between the results with health care practices one year after the last interview will be performed
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: LLERENA catherine, MD, CHU GA Grenobe France
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 38RC17.005
- 2017-A00062-51 (Annan identifierare: ID RCB)
Plan för individuella deltagardata (IPD)
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