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Transition of Care in Pediatric Rare Endocrine Disorders (TRANSPIRE)

21. august 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sør -Korea
      • Daegu, Sør -Korea
        • Har ikke rekruttert ennå
        • Kyungpook National University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Jae-Han Jeon
      • Daegu, Sør -Korea
        • Har ikke rekruttert ennå
        • Daegu Catholic University Medical Center
        • Ta kontakt med:
        • Underetterforsker:
          • Eonju Jeon
      • Daejeon, Sør -Korea
        • Har ikke rekruttert ennå
        • Chungnam National University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Ju Hee Lee
      • Gwangju, Sør -Korea
        • Har ikke rekruttert ennå
        • Chonnam National University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Dong Jin Chung
      • Hwasun, Sør -Korea
        • Har ikke rekruttert ennå
        • Hwasun Chonnam National University Hospital
        • Ta kontakt med:
      • Incheon, Sør -Korea
        • Har ikke rekruttert ennå
        • Inha University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Seongbin Hong
      • Jeonju, Sør -Korea
        • Har ikke rekruttert ennå
        • Jeonbuk National University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Ji Hyun Park
      • Seongnam, Sør -Korea
        • Har ikke rekruttert ennå
        • Seoul National University Bundang Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Sung Hye Kong
      • Seoul, Sør -Korea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Jung Hee Kim
      • Seoul, Sør -Korea
        • Har ikke rekruttert ennå
        • Korea University Guro Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Min Jeong Park
      • Seoul, Sør -Korea
        • Har ikke rekruttert ennå
        • Konkuk University Medical Center
        • Ta kontakt med:
        • Underetterforsker:
          • Kee-Ho Song

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Successfully Transferred to Adult Endocrinology Care
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Transition Readiness Assessment Questionnaire Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Seoul National University Hospital

Samarbeidspartnere

SNUH Lee Kun-hee Child Cancer & Rare Disease Project

Etterforskere

  • Hovedetterforsker: Yun Jeong Lee, Seoul National University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

21. august 2026

Først innsendt som oppfylte QC-kriteriene

21. august 2026

Først lagt ut (Faktiske)

25. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25C0710100

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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