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CompletedNCT03298685SAFETIM-needsUpdated Mar 30, 2020

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

An observational study in Cystic Fibrosis and Adolescent Behavior, sponsored by University Hospital, Grenoble. Completed at 4 sites in France. Open to participants aged 17 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
17 Years to 23 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cystic Fibrosis
  • Adolescent Behavior

Browse trials for

Keywords

  • transition
  • care program
  • needs
03

Who can participate

Ages eligible
17 Years to 23 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

Exclusion Criteria:

  • none
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othersemi 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

05

What researchers measure

Primary outcomes

  1. Identify CF adolescents and their parents needs before transition

    Qualitative analysis of interviews

    Time frame: 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.

  2. Identify CF adolescents and their parents experience after transition

    Qualitative analysis of interviews

    Time frame: 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

  1. What do they need, to feel safe before transition

    Identify patients and parents needs

    Time frame: 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

  2. 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

    Time frame: 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

  3. Which factors influence quality of transition other than TPE dimension.

    Satisfaction level of Patients and Family After Transition

    Time frame: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched

  4. 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

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

06

Study locations

4 sites
  • University Hospital, Clermont-Ferrand
    Clermont-Ferrand, 63003, France
  • UniversityHospitalGrenoble
    Grenoble, 38043, France
  • Hôpital Femme Mère Enfant, HCL
    Lyon, 69322, France
  • South Hospital of Lyon, HCL
    Pierre Bénite, 69495, France
07

References and documents

Publications

  • 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. PubMed 22114471 ↗
  • 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. PubMed 24376344 ↗
  • 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. PubMed 8312295 ↗
  • 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. PubMed 20040605 ↗
  • 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. PubMed 25287460 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03298685
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Jun 12, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Mar 30, 2020

Study contacts

LLERENA catherine, MD
principal investigator · CHU GA Grenobe France

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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