Telemedicine to Support Living Kidney Donor Candidates

Not Applicable

Recruiting

• Conditions: Healthy; Living Kidney Donation

• Registration Number: NCT07206069
• Lead Sponsor: University of California, Irvine

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-09-10
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-10
• Primary Completion: 2026-09-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	90 days	Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.
Retention Rate	90 days	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.
Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Completion of Donor Education and Evaluation and Counseling	90 days	Completion of donor education and evaluation and counseling.; Time to donor evaluation and counseling completion.
Intervention Acceptability	Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days	Participant-reported acceptability of the telemedicine intervention will be measured using the acceptability of intervention measure. This outcome will be assessed only in the Telemedicine Intervention Arm.

Trial Locations

Locations (1)

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States