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Completed

NCT Number: NCT03298685

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

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

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Key information

Conditions

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

Age range

17 year–23 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: SAFETIM-needs

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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