SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers (SAFETIM-needs)
2020年3月27日 更新者：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
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
50
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Clermont-Ferrand、フランス、63003
- University Hospital, Clermont-Ferrand
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Grenoble、フランス、38043
- UniversityHospitalGrenoble
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Lyon、フランス、69322
- Hôpital Femme Mère Enfant, HCL
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Pierre Bénite、フランス、69495
- South Hospital of Lyon, HCL
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
17年～23年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
|
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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identify CF adolescents and their parents needs before transition
時間枠：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.
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Qualitative analysis of interviews
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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.
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Identify CF adolescents and their parents experience after transition
時間枠：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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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What do they need, to feel safe before transition
時間枠：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
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Identify patients and parents needs
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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
|
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Do these needs of CFadolescent and their parents taken into account in the transition procedures
時間枠：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
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Do the procedures take into account the needs of patients and parents
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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
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Which factors influence quality of transition other than TPE dimension.
時間枠：Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
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Satisfaction level of Patients and Family After Transition
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Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
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Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
時間枠：comparison between the results with health care practices one year after the last interview will be performed
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Identifying key points of the patient's personalized transition, the timing and personalization of the health care course during the transition
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comparison between the results with health care practices one year after the last interview will be performed
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：LLERENA catherine, MD、CHU GA Grenobe France
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年6月12日
一次修了 (実際)
2018年12月31日
研究の完了 (実際)
2018年12月31日
試験登録日
最初に提出
2017年8月1日
QC基準を満たした最初の提出物
2017年9月26日
最初の投稿 (実際)
2017年10月2日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月30日
QC基準を満たした最後の更新が送信されました
2020年3月27日
最終確認日
2020年3月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 38RC17.005
- 2017-A00062-51 (その他の識別子：ID RCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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