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

NCT03298685 | Completed DMC

• 2 other identifiers: 38RC17.0052017-A00062-51
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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

Conditions

Cystic Fibrosis; Adolescent Behavior

Keywords

transition; care program; needs

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• What do they need, to feel safe before transition

  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

  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.

  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

  comparison between the results with health care practices one year after the last interview will be performed

Study Arms (1)

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.

Other: semi structured interviews for all adolescents and their parent

Interventions

semi structured interviews for all adolescents and their parent OTHER

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

CF patient and parents cohort in 3 CF center

Eligibility Criteria

• Age: 17 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (4)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

UniversityHospitalGrenoble

Grenoble, 38043, France

Location

Hôpital Femme Mère Enfant, HCL

Lyon, 69322, France

Location

South Hospital of Lyon, HCL

Pierre-Bénite, 69495, France

Location

Related Publications (5)

• 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.

  PMID: 22114471 BACKGROUND

• 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.

  PMID: 24376344 BACKGROUND

• 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.

  PMID: 8312295 BACKGROUND

• 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.

  PMID: 20040605 BACKGROUND

• 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.

  PMID: 25287460 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Adolescent Behavior

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• LLERENA catherine, MD

  CHU GA Grenobe France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: October 2, 2017
• Study Start: June 12, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)