- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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New Jersey
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Livingston, New Jersey, Vereinigte Staaten, 07039
- Saint Barnabas Medical Center
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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:
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Zeitfenster: 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
Zeitfenster: (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
Zeitfenster: (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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Francis L Weng, MD, St. Barnabas Medical Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SBMC-2009-53
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