SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers

Cystic Fibrosis Clinical Trial

— SAFETIM-needs  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298685
• Other study ID #: 38RC17.005
• Secondary ID: 2017-A00062-51
• Status: Completed
• Start date: June 12, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Cystic Fibrosis

Intervention

Other:
• semi structured interviews for all adolescents and their parent
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

Locations

Country	Name	City	State
France	University Hospital, Clermont-Ferrand	Clermont-Ferrand
France	UniversityHospitalGrenoble	Grenoble
France	Hôpital Femme Mère Enfant, HCL	Lyon
France	South Hospital of Lyon, HCL	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Bregnballe V, Schiøtz 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify CF adolescents and their parents needs before transition	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.
Primary	Identify CF adolescents and their parents experience after transition	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.
Secondary	What do they need, to feel safe before transition	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
Secondary	Do these needs of CFadolescent and their parents taken into account in the transition procedures	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
Secondary	Which factors influence quality of transition other than TPE dimension.	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
Secondary	Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations	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