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

NCT ID: NCT05468463

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-02-28

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.

Detailed Description

Transplant candidate-related and potential living donor-related factors, including difficulty asking family/friends to donate on one's behalf and lack of knowledge about the donation process, respectively, have been implicated in lower donation rates. The investigators will conduct an individually randomized group trial (IRGT) with delayed intervention initiation allowing for: (1) scalability/ implementation in a less resource-intensive fashion compared to traditional randomized trials; (2) Avoid self-selection bias as all participants ultimately participate in the intervention. The LDN Program combines advocacy-training to overcome barriers in initiating conversations with and identification of potential living donors with the use of non-clinical navigators to guide donors through the evaluation process. Participants will be randomized to one of two arms; Arm 1 includes the LDN program via in-person modality, and Arm 2 includes the LDN program via tele-health modality. The investigators primary objective is to demonstrate the effectiveness of these interventions in increasing living donation.

Conditions

Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Living Donor Navigator Program In-person

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.

Group Type: ACTIVE_COMPARATOR

Living Donor Navigator Program

Intervention Type: 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 Tele-health

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.

Group Type: ACTIVE_COMPARATOR

Living Donor Navigator Program

Intervention Type: 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.

Interventions

Living Donor Navigator Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Vineeta Kumar

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vineeta Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

R01DK125509

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300002556

Identifier Type: -

Identifier Source: org_study_id