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NCT Number: NCT07206069

Telemedicine to Support Living Kidney Donor Candidates

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.

Recruiting

Interested in participating?

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Key information

Conditions

Healthy Living Kidney Donation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard Care (in control arm)

Behavioral

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

Other names: Control

Telemedicine Shared Decision-Making

Behavioral

This intervention involves two live telemedicine video visits.

Other names: Experimental

Primary outcomes

  1. Recruitment Rate

    Time frame: 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.

  2. Retention Rate

    Time frame: 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.

  3. Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)

    Time frame: 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 outcomes

  1. Completion of Donor Education and Evaluation and Counseling

    Time frame: 90 days

    Completion of donor education and evaluation and counseling.

    Time to donor evaluation and counseling completion.

  2. Intervention Acceptability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fawaz Al Ammary, MD PhD

CONTACT

[email protected]

657-223-4966

Ivette Nunez, BS

CONTACT

[email protected]

949-824-7315

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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