Promoting Increases in Living Donation Via Tele-navigation (PILOT)

NCT05468463 | Active Not Recruiting DMC

• 2 other identifiers: IRB-300002556R01DK125509
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that expansion of the Living Donor Navigator (LDN) program to include tele-health delivery will overcome geographic disparities in access and facilitate sustained increases in living donation. We will utilize an individually randomized group trial (IRGT) design with delayed intervention initiation to compare the effectiveness of tele-health LDN model to standard of care.

Conditions

Kidney Diseases

Keywords

Kidney Disease; Kidney; End Stage Kidney Disease; Living Donation; Telehealth; Transplant; Remote; Virtual

Outcome Measures

Primary Outcomes (2)

• Number Live Donor Screenings

  The number of living donors screened on behalf of transplant candidates will be collected/ identified through the electronic medical record system.

  Within 3 months of condition

• Number of Live Donor Approvals

  The number of living donor approvals on behalf of transplant candidates will be collected/ identified through the electronic medical record system.

  Within 3 months of condition

Study Arms (2)

Living Donor Navigator Program In-person

ACTIVE COMPARATOR

The LDN program is designed to help transplant candidates find potential donors, and guide potential living donors through the evaluation/ donation process. The LDN program consists of four educational sessions, with each session building on the last. Each educational session lasts approximately 2 hours and is held once every other week for two months. Each LDN session will be conducted by a living donor navigator. As potential living donors are identified, the living donor navigators will work closely with the potential donors to guide them through each step of the evaluation/donation process to ensure streamlined medical services and a personalized experience. Individuals randomized to LDN in-person will receive the program locally at the transplant center.

Behavioral: Living Donor Navigator Program

Living Donor Navigator Program Tele-health

ACTIVE COMPARATOR

The LDN program is designed to help transplant candidates find potential donors, and guide potential living donors through the evaluation/ donation process. The LDN program consists of four educational sessions, with each session building on the last. Each educational session lasts approximately 2 hours and is held once every other week for two months. Each LDN session will be conducted by a living donor navigator. As potential living donors are identified, the living donor navigators will work closely with the potential donors to guide them through each step of the evaluation/donation process to ensure streamlined medical services and a personalized experience. Individuals randomized to LDN tele-health will receive the program virtually at a local health department within the Alabama Department of Public Health's tele-health network.

Behavioral: Living Donor Navigator Program

Interventions

Living Donor Navigator Program BEHAVIORAL

The investigators have developed a 4-session educational program that simultaneously addresses potential donor concerns with the evaluation/donation process and provides advocacy training to transplant candidates and their advocates.

Living Donor Navigator Program In-person; Living Donor Navigator Program Tele-health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage kidney disease (ESKD) patients who are ≥ 18 years old and have initiated evaluation for kidney transplantation.
• If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the study and may still benefit from identification of new donors or increased comfort accepting donation from others.
• Candidates must be English-speaking or deaf with an interpreter.

You may not qualify if:

• Individuals under the age of 18 will be excluded from the study.
• Individuals who are not English speaking will be excluded from the study.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vineeta Kumar, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 21, 2022
• Study Start: April 12, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)