Clinical trial NCT03298685: SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Adolescent Behavior
Keywords: transition
care program
needs
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 17
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify CF adolescents and their parents needs before transition
timeFrame: 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.
measure: Identify CF adolescents and their parents experience after transition
timeFrame: 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.
Secondary outcomes:
measure: What do they need, to feel safe before transition
timeFrame: 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
measure: Do these needs of CFadolescent and their parents taken into account in the transition procedures
timeFrame: 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
measure: Which factors influence quality of transition other than TPE dimension.
timeFrame: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
measure: Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
timeFrame: comparison between the results with health care practices one year after the last interview will be performed
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont-Ferrand
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant, HCL
city: Pierre Bénite
country: France
facility: South Hospital of Lyon, HCL
Study officials:
affiliation: CHU GA Grenobe France
name: LLERENA catherine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.