Telemedicine to Support Living Kidney Donor Candidates

NCT07206069 | Recruiting

• 2 other identifiers: UC Irvine IRB#4138K23DK129820
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Living Kidney Donation

Keywords

Kidney donation; Telemedicine; Education; Counseling; Decision Making, Shared; Feasibility studies; Health Services Research; Care Delivery

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate

  Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.

  90 days

• Retention Rate

  Proportion of enrolled participants who remain in the study through the 90-day follow-up period, calculated as the number completing final follow-up divided by the number enrolled.

  90 days

• Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)

  Decision conflict will be measured using the Decisional Conflict Scale (DCS), a 16-item validated instrument. Each item is scored from 0 (no conflict) to 100 (very high conflict), and a total score is calculated by averaging across items. Total scores therefore range from 0 to 100, with higher scores indicating worse decision conflict and greater uncertainty.

  90 days

Secondary Outcomes (2)

• Completion of Donor Education and Evaluation and Counseling

  90 days

• Intervention Acceptability

  Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days

Study Arms (2)

Standard Care Group (Control)

ACTIVE COMPARATOR

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.

Behavioral: Standard Care (in control arm)

Telemedicine Group (Intervention)

EXPERIMENTAL

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.

Behavioral: Telemedicine Shared Decision-Making

Interventions

Standard Care (in control arm) BEHAVIORAL

This Standard Care involves a recorded video education and in-person visit.

Also known as: Control

Standard Care Group (Control)

Telemedicine Shared Decision-Making BEHAVIORAL

This intervention involves two live telemedicine video visits.

Also known as: Experimental

Telemedicine Group (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fawaz Al Ammary, MD PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fawaz Al Ammary, MD PhD

CONTACT

657-223-4966; fawaz.alammary@uci.edu

Ivette Nunez, BS

CONTACT

949-824-7315; ivetter4@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Director of Mixed Methods Research.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 3, 2025
• Study Start: May 4, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Shared data will be made available at the time of publication of the primary results. Data will remain available in the Dryad repository for a minimum of 5 years.
• Access Criteria: Shared data will be made available through the Dryad digital repository. Supporting materials will include a data dictionary, study protocol, and statistical analysis plan. In accordance with the NIH Data Management and Sharing Plan and UC Irvine IRB guidance, no personally identifiable information will be included. Data will be shared under a CC0 waiver, allowing other researchers to reuse the de-identified data for health, medical, or biomedical research purposes.

Locations

US (1)