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

March 27, 2020 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify CF adolescents and their parents needs before transition
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
What do they need, to feel safe before transition
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
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
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
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.
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
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: LLERENA catherine, MD, CHU GA Grenobe France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.005
  • 2017-A00062-51 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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