Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
7. desember 2020 oppdatert av: Jee-Young Nina Ham, Emory University
The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:
- facilitate the adjustment of children and their families to the rigors of diabetes care
- improve adherence to medication regimens
- reduce acute complications of diabetes and organ rejection.
Studietype
Intervensjonell
Registrering (Faktiske)
65
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Emory Children's Center
-
Atlanta, Georgia, Forente stater, 30322
- Children's Healthcare of Atlanta-Egleston
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-
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
1 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant
Exclusion Criteria:
- Received a transplant after 18 years of age
- Cognitively unable to participant as determined by the study team psychologist
- Not receiving a solid organ transplant for kidney, liver, or heart
- Declines participation invitation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Participants
Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening.
Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively.
|
Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II).
Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.
Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families.
Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
Tidsramme: Baseline, interval, and end of participation (Up to 18 years of age)
|
The Pediatric Quality of Life Inventory Transplant Module (PedsQL) is a 15 minute survey intended to measure emotional and physical function in children and determine state of wellbeing.
|
Baseline, interval, and end of participation (Up to 18 years of age)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Transplant Rejection Rate Post Diabetes Diagnosis
Tidsramme: Up to three years
|
Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of transplant rejection after being diagnosed with diabetes.
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Up to three years
|
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Rate of Vascular Disease Post Diabetes Diagnosis
Tidsramme: Up to three years
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Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of vascular disease after being diagnosed with diabetes.
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Up to three years
|
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Mortality Rate Post Diabetes Diagnosis
Tidsramme: Up to three years
|
Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of mortality after being diagnosed with diabetes.
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Up to three years
|
|
Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score
Tidsramme: Baseline, interval, and end of participation (Up to 18 years)
|
The Wechsler Abbreviated Scale of Intelligence II (WASI-II) is intended to determine cognitive ability for use in educational, as well as clinical and research settings.
The WASI-II is ideal for any subject over the age of six, and takes approximately one hour to complete.
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Baseline, interval, and end of participation (Up to 18 years)
|
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Change in the Children Depression Inventory (CDI 2) Score
Tidsramme: Baseline, interval, and end of participation (Up to 18 years)
|
The Children Depression Inventory (CDI 2) is a short ten minute self-reported survey intended to aid in the assessment of signs of depression in children ages seven through 17.
This test helps determine negative mood, poor self-esteem, a loss of interest in activities, interpersonal problems, and feelings of ineffectiveness, the common traits of depression.
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Baseline, interval, and end of participation (Up to 18 years)
|
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Change in the Behavior Assessment System for Children (BASC) Score
Tidsramme: Baseline, interval, and end of participation (Up to 18 years)
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The Behavior Assessment System for Children (BASC) takes approximately 15 minutes to complete and is intended to determine emotional and behavioral change in children, as well as to indicate risks to their health and development
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Baseline, interval, and end of participation (Up to 18 years)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Nina Ham, MD, Emory University
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)
7. juli 2016
Primær fullføring (Faktiske)
14. november 2018
Studiet fullført (Faktiske)
14. november 2018
Datoer for studieregistrering
Først innsendt
6. oktober 2015
Først innsendt som oppfylte QC-kriteriene
12. november 2015
Først lagt ut (Anslag)
16. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB00081257
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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