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Transition of Care in Pediatric Rare Endocrine Disorders (TRANSPIRE)

21 augusti 2026 uppdaterad av: Yun Jeong Lee, Seoul National University Hospital

Transition of Care in Pediatric Rare Endocrine Disorders: Assessing Unmet Needs and Implementing a Standardized Transition Program

This study will evaluate the transition from pediatric to adult care in patients with pediatric-onset rare endocrine disorders. The study includes three components: a review of medical records to assess previous transition outcomes, a survey of adult patients about transition experiences and quality of life, and an evaluation of a structured transition program for participants aged 18 years or older. The transition program provides assessment of transition readiness, individualized education, clinical information transfer, coordinated care between pediatric and adult endocrinology teams, and follow-up after transfer. Researchers will evaluate transfer and retention in adult care, transition readiness, quality of life, appointment attendance, satisfaction, and clinical outcomes.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study consists of three components. First, current transition practices and outcomes will be evaluated through retrospective medical record review. Second, a survey of adult patients will assess their transition experiences, unmet needs, and quality of life. Third, a standardized transition program will be prospectively evaluated in eligible participants preparing to transfer from pediatric to adult endocrinology care.

The transition program includes standardized assessment of transition readiness, disease knowledge, quality of life, and psychological status, together with individualized education, preparation of a clinical information summary and disease-specific checklist, coordinated transfer between pediatric and adult endocrinology teams, and follow-up after transfer.

The study is designed to characterize current transition practices and unmet needs and to evaluate whether a standardized transition program can improve the transition from pediatric to adult endocrine care.

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Sydkorea
      • Daegu, Sydkorea
        • Har inte rekryterat ännu
        • Kyungpook National University Hospital
        • Kontakt:
        • Underutredare:
          • Jae-Han Jeon
      • Daegu, Sydkorea
        • Har inte rekryterat ännu
        • Daegu Catholic University Medical Center
        • Kontakt:
        • Underutredare:
          • Eonju Jeon
      • Daejeon, Sydkorea
        • Har inte rekryterat ännu
        • Chungnam National University Hospital
        • Kontakt:
        • Underutredare:
          • Ju Hee Lee
      • Gwangju, Sydkorea
        • Har inte rekryterat ännu
        • Chonnam National University Hospital
        • Kontakt:
        • Underutredare:
          • Dong Jin Chung
      • Hwasun, Sydkorea
        • Har inte rekryterat ännu
        • Hwasun Chonnam National University Hospital
        • Kontakt:
      • Incheon, Sydkorea
        • Har inte rekryterat ännu
        • Inha University Hospital
        • Kontakt:
        • Underutredare:
          • Seongbin Hong
      • Jeonju, Sydkorea
        • Har inte rekryterat ännu
        • Jeonbuk National University Hospital
        • Kontakt:
        • Underutredare:
          • Ji Hyun Park
      • Seongnam, Sydkorea
        • Har inte rekryterat ännu
        • Seoul National University Bundang Hospital
        • Kontakt:
        • Underutredare:
          • Sung Hye Kong
      • Seoul, Sydkorea, 03080
        • Rekrytering
        • Seoul National University Hospital
        • Kontakt:
        • Underutredare:
          • Jung Hee Kim
      • Seoul, Sydkorea
        • Har inte rekryterat ännu
        • Korea University Guro Hospital
        • Kontakt:
        • Underutredare:
          • Min Jeong Park
      • Seoul, Sydkorea
        • Har inte rekryterat ännu
        • Konkuk University Medical Center
        • Kontakt:
        • Underutredare:
          • Kee-Ho Song

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of a pediatric-onset rare endocrine disorder, including rare metabolic bone and mineral disorders, hypopituitarism, congenital adrenal hyperplasia, rare endocrine tumors, and syndromic or chromosomal disorders requiring endocrine care.
  • Currently receiving follow-up care in the pediatric endocrinology department of a participating institution.
  • Willing to participate in the standardized transition-of-care program and able to provide written informed consent.

Exclusion Criteria:

  • none

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Structured Transition-of-Care Program
Participants will receive a structured transition-of-care program including assessment of transition readiness and disease knowledge, individualized education, preparation of a clinical information summary and disease-specific checklist, coordinated transfer from pediatric to adult endocrinology care, and structured follow-up after transfer.
Beteende: Structured Transition-of-Care Program
The program includes assessment of transition readiness and disease knowledge, individualized education, preparation of a clinical information summary and disease-specific checklist, coordinated transfer between pediatric and adult endocrinology teams, and structured follow-up after transfer.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of Participants Successfully Transferred to Adult Endocrinology Care
Tidsram: Within 6 months after transfer to adult endocrinology care
The proportion of participants who successfully transfer to adult endocrinology care will be calculated as the number of participants who complete their first adult endocrinology outpatient visit after transfer from pediatric care divided by the number of participants enrolled in the standardized transition-of-care program.
Within 6 months after transfer to adult endocrinology care

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Transition Readiness Assessment Questionnaire Score
Tidsram: Baseline and at the first or second adult endocrinology visit after transfer
Transition readiness will be assessed using the Transition Readiness Assessment Questionnaire at baseline and after transition to adult care. Scores will be calculated according to the validated scoring method, with higher scores indicating greater transition readiness. Change will be calculated as the post-transition score minus the baseline score.
Baseline and at the first or second adult endocrinology visit after transfer
Change in Transition-Related Anxiety Score
Tidsram: Baseline and at the first or second adult endocrinology visit after transfer
Transition-related anxiety will be assessed at baseline and after transition to adult care using the study-specific transition evaluation questionnaire. Change will be calculated as the post-transition score minus the baseline score, with higher scores indicating greater transition-related anxiety.
Baseline and at the first or second adult endocrinology visit after transfer
Participant Satisfaction With the Transition Process
Tidsram: Baseline and at the first or second adult endocrinology visit after transfer
Participant satisfaction with the transition program and adult-oriented care will be assessed using the post-transition evaluation questionnaire. The total score will be calculated according to the study-specific scoring method, with higher scores indicating greater satisfaction.
Baseline and at the first or second adult endocrinology visit after transfer
Retention in Adult Endocrinology Care at 12 Months
Tidsram: 12 months after the first adult endocrinology visi
The proportion of participants who remain in adult endocrinology care at 12 months after their first adult endocrinology visit will be assessed. Retention will be defined as continued attendance at scheduled adult endocrinology follow-up visits during the 12-month period.
12 months after the first adult endocrinology visi

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Seoul National University Hospital

Samarbetspartners

SNUH Lee Kun-hee Child Cancer & Rare Disease Project

Utredare

  • Huvudutredare: Yun Jeong Lee, Seoul National University Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 maj 2026

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

21 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

21 augusti 2026

Första postat (Faktisk)

25 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 25C0710100

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant-level data are not planned to be publicly shared because the study includes participants with rare endocrine disorders, and a potential risk of participant re-identification may remain even after removal of direct identifiers. Aggregate study results may be reported in scientific publications and presentations.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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