- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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New Jersey
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Livingston, New Jersey, Stati Uniti, 07039
- Saint Barnabas Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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:
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Lasso di tempo: 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
Lasso di tempo: (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
Lasso di tempo: (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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Francis L Weng, MD, St. Barnabas Medical Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SBMC-2009-53
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .