- ICH GCP
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- Klinische proef NCT01261910
Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
The primary purpose of this study is to test different methods by which kidney transplant centers can educate potential transplant candidates about living donor kidney transplant (LDKT).
The most effective ways to educate kidney transplant candidates about LDKT remain unclear. The goal is to determine, among a diverse cohort of potential kidney transplant candidates, whether a transplant center-based intervention will increase understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT. The investigators hypothesize that kidney transplant candidates' understanding of living kidney donation and LDKT will be increased by interventions implemented at the transplant center on the day of transplant evaluation.
The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to compare the effects of two educational strategies upon transplant candidates' understanding of living kidney donation and LDKT:
- Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and
- Intensive initial transplant education implemented on the day of the transplant evaluation.
Intensive initial transplant education will utilize videos of living donors' experiences as well as a session with a trained Transplant Educator, who will focus upon living donation education. One week after the transplant evaluation day and 3 months later, the investigators will assess transplant candidates' knowledge of LDKT (using questionnaires), identify correlates of increased understanding of LDKT, and assess racial/ethnic differences in the understanding of LDKT.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New Jersey
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Livingston, New Jersey, Verenigde Staten, 07039
- Saint Barnabas Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Appear for initial kidney transplant evaluation at Saint Barnabas Medical Center
- 18 years of age or older
- Able to provide informed consent
- Able to speak, hear, and understand English
Exclusion Criteria:
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Usual education (standard care)
On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant.
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Experimenteel: Intensive initial education
On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant.
In addition, participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person.
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Participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Tijdsspanne: Up to 1 week after the transplant education day
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Up to 1 week after the transplant education day
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Tijdsspanne: Three months after the transplant education day
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Three months after the transplant education day
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Attitudes, confidence, and opinions regarding living kidney donation and LDKT
Tijdsspanne: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
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(1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
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Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT
Tijdsspanne: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day, compared to prior to the transplant evaluation day (baseline)
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(1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day, compared to prior to the transplant evaluation day (baseline)
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Francis L Weng, MD, St. Barnabas Medical Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SBMC-2009-53
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