Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-10-10
2026-11-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Care Group (Control)
Participants in the standard care group will receive a recorded video education session and one in-person donor evaluation and counseling session with a nephrologist.
Standard Care (in control arm)
This Standard Care involves a recorded video education and in-person visit.
Telemedicine Group (Intervention)
Participants in the telemedicine group will receive two live telemedicine video sessions: one education session with a transplant provider and one donor evaluation and counseling session with a nephrologist.
Telemedicine Shared Decision-Making
This intervention involves two live telemedicine video visits.
Interventions
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Standard Care (in control arm)
This Standard Care involves a recorded video education and in-person visit.
Telemedicine Shared Decision-Making
This intervention involves two live telemedicine video visits.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Reside in the State of California
* Registered living kidney donor candidate at UC Irvine Medical Center
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, Irvine
OTHER
Responsible Party
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Fawaz Al Ammary
Associate Professor of Medicine, Director of Mixed Methods Research.
Principal Investigators
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Fawaz Al Ammary, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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University of California Irvine Medical Center
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UC Irvine IRB#4138
Identifier Type: -
Identifier Source: org_study_id
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