Telemedicine to Support Living Kidney Donor Candidates

University of California Irvine (UCI)

Status: Enrolling

Conditions: Healthy; Living Kidney Donation

Treatments: Behavioral: Telemedicine Shared Decision-Making; Behavioral: Standard Care (in control arm)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07206069

UC Irvine IRB#4138

K23DK129820 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Standard Care Group (Control)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Care (in control arm)

Telemedicine Group (Intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Telemedicine Shared Decision-Making