Telemedicine to Support Living Kidney Donor Candidates

Официальное название

Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates

Обзор

The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are: * Is telemedicine a practical way to facilitate donor education and evaluation and counseling? * Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process? Researchers will compare standard care with a telemedicine care coordination approach. Participants will: \- Receive either standard care or telemedicine video visits to support shared decision making.

Подробное описание

Living kidney donation provides a vital treatment option for patients with kidney failure, but many willing individuals face challenges in completing the donor evaluation and committing to donation. Donor education and counseling are essential for informed decision-making, yet these steps are often limited to in-person visits at transplant centers. This can create logistical challenges, delays, and variations in access to the living donor evaluation process. Telemedicine offers an opportunity to deliver a shared decision making approach to donor education and evaluation and counseling remotely, but its feasibility, acceptability, and impact have not been well studied.

This pilot feasibility clinical trial is designed to test whether a telemedicine care coordination can support donor decision-making and engagement during the evaluation process for living kidney donation.

Participants will be randomly assigned to one of two groups:

* Standard Care Group (Control): A recorded video education session and an in-person donor evaluation and counseling with a nephrologist. * Telemedicine Group (Intervention): Two live telemedicine video sessions-one for education with a transplant provider and one for donor evaluation and counseling with a nephrologist.

The findings from this feasibility trial will provide important information about the practicality and acceptability of telemedicine shared decision-making for living kidney donor candidates. Generated preliminary data will inform larger trials and ultimately guide transplant practice and policy to improve decision-making, efficiency, and access to living kidney donation.

Вмешательства

• Поведенческое Standard Care (in control arm)
  This Standard Care involves a recorded video education and in-person visit.
• Поведенческое Telemedicine Shared Decision-Making
  This intervention involves two live telemedicine video visits.

Первичные конечные точки

• Recruitment Rate [Срок оценки: 90 days]
• Retention Rate [Срок оценки: 90 days]
• Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS) [Срок оценки: 90 days]

Вторичные конечные точки (2)

• Completion of Donor Education and Evaluation and Counseling [Срок оценки: 90 days]
• Intervention Acceptability [Срок оценки: Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days]

Критерии участия

Критерии включения

• 18 years of age or older
• Reside in the State of California
• Registered living kidney donor candidate at UC Irvine Medical Center

Критерии исключения

\- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of California Irvine Medical Center — Orange

Публикации

• Al Ammary F, Adeyemo S, Lentine KL, Muzaale AD. Evolution of Biologically Related Living Kidney Donation in the United States from 1988 to 2022. J Am Soc Nephrol. 2024 Aug 1;35(8):1104-1106. doi: 10.1681/ASN.0000000000000424. Epub 2024 May 29. No abstract available. PMID 38809617
• Al Ammary F, Yu Y, Ferzola A, Motter JD, Massie AB, Yu S, Thomas AG, Crews DC, Segev DL, Muzaale AD, Henderson ML. The first increase in live kidney donation in the United States in 15 years. Am J Transplant. 2020 Dec;20(12):3590-3598. doi: 10.1111/ajt.16136. Epub 2020 Jul 17. PMID 32524764
• Achkar KA, Abdelnour LM, Abu Jawdeh BG, Tantisattamoa E, Al Ammary F. Evaluation and Long-Term Follow-Up of Living Kidney Donors. Adv Kidney Dis Health. 2024 Sep;31(5):400-407. doi: 10.1053/j.akdh.2024.04.003. PMID 39232610
• Al Ammary F, Bowring MG, Massie AB, Yu S, Waldram MM, Garonzik-Wang J, Thomas AG, Holscher CM, Qadi MA, Henderson ML, Wiseman AC, Gralla J, Brennan DC, Segev DL, Muzaale AD. The changing landscape of live kidney donation in the United States from 2005 to 2017. Am J Transplant. 2019 Sep;19(9):2614-2621. doi: 10.1111/ajt.15368. Epub 2019 May 3. PMID 30903733
• Al Ammary F, Motter JD, Sung HC, Lentine KL, Sharfuddin A, Kumar V, Yadav A, Doshi MD, Virmani S, Concepcion BP, Grace T, Sidoti CN, Yahya Jan M, Muzaale AD, Wolf J. Telemedicine services for living kidney donation: A US survey of multidisciplinary providers. Am J Transplant. 2022 Aug;22(8):2041-2051. doi: 10.1111/ajt.17093. Epub 2022 May 31. PMID 35575439
• Al Ammary F, Muzaale AD, Tantisattamoa E, Hanna RM, Reddy UG, Bunnapradist S, Kalantar-Zadeh K. Changing landscape of living kidney donation and the role of telemedicine. Curr Opin Nephrol Hypertens. 2023 Jan 1;32(1):81-88. doi: 10.1097/MNH.0000000000000848. Epub 2022 Oct 21. PMID 36444666
• Kim E, Sung HC, Kaplow K, Bendersky V, Sidoti C, Muzaale AD, Akhtar J, Levan M, Esayed S, Khan A, Mejia C, Al Ammary F. Donor Perceptions and Preferences of Telemedicine and In-Person Visits for Living Kidney Donor Evaluation. Kidney Int Rep. 2024 May 15;9(8):2453-2461. doi: 10.1016/j.ekir.2024.05.009. eCollection 2024 Aug. PMID 39156145

Идентификаторы

NCT: NCT07206069 · UC Irvine IRB#4138 · K23DK129820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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