Living Donor Navigation for Kidney Disease

(PILOT Trial)

Overseen By Jayme E Locke, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Under 18, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

347 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Living Donor Navigator Program treatment for kidney disease?

Research shows that participating in the Living Donor Navigator Program increases the chances of getting a living donor kidney transplant. Additionally, using trained kidney transplant recipients as guides helps more patients complete the transplant process. ^{1 2 3 4 5}

Is the Living Donor Navigation for Kidney Disease program safe for participants?

The available research does not provide specific safety data for the Living Donor Navigation program, but it focuses on increasing awareness and linking donors with recipients, which suggests it is primarily educational and supportive in nature. ^{1 2 3 4 6}

How is the Living Donor Navigator Program treatment different from other treatments for kidney disease?

The Living Donor Navigator Program is unique because it pairs kidney transplant candidates with a friend or family member who acts as an advocate, helping to identify potential donors and navigate the healthcare system. This program focuses on enhancing advocacy and providing support tools for both candidates and their caregivers, which is not typically addressed in standard treatments for kidney disease. ^{1 2 7 8 9}

Research Team

Vineeta Kumar, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 with end-stage kidney disease who are evaluating their options for a kidney transplant. It's open to English speakers, including deaf individuals with interpreters. People unwilling to consider living donors or those under 18 cannot participate.

Inclusion Criteria

I am open to considering new organ donors or becoming more comfortable with the idea of receiving a donation.

I am over 18 with end-stage kidney disease and am being evaluated for a kidney transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Living Donor Navigator (LDN) program, consisting of four educational sessions over two months, either in-person or via tele-health.

8 weeks

4 sessions (in-person or virtual)

Follow-up

Participants are monitored for the number of live donor screenings and approvals within 3 months.

12 weeks

Treatment Details

Interventions

• Living Donor Navigator Program

Trial Overview The study tests if a Living Donor Navigator Program delivered via tele-health can increase living kidney donations compared to standard care. Participants will be randomly assigned to receive the program immediately or after a delay.

Participant Groups

Group I: Living Donor Navigator Program In-person Active Control 1 Intervention

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 II: Living Donor Navigator Program Tele-health Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Technology-based interventions (TBI) can significantly enhance awareness and knowledge about living donor kidney transplantation (LDKT), particularly among African American and Hispanic populations, which have seen a decline in LDKT rates.

In a review of 31 studies, 60% of patient-facing TBIs and 75% of donor-facing TBIs showed increased linkage between potential donors and transplant candidates, indicating that customized and accessible TBI can effectively connect these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of technology-based interventions on linking potential kidney donors and transplant candidates: a scoping review. Deshpande, PP., Jariwala, S., Martin, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Social Vulnerability on Access to Educational Programming Designed to Enhance Living Donation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Qualitative Assessment of the Living Donor Navigator Program to Identify Core Competencies and Promising Practices for Implementation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Experiences of Kidney Transplant Recipients as Patient Navigators. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of technology-based interventions on linking potential kidney donors and transplant candidates: a scoping review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Greater community vulnerability is associated with poor living donor navigator program fidelity. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Post-nephrectomy development of renal function in living kidney donors: a cross-sectional retrospective study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Self-advocacy is associated with lower likelihood of living donor kidney transplantation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Enhanced Advocacy and Health Systems Training Through Patient Navigation Increases Access to Living-donor Kidney Transplantation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Living Donor Navigator Program Provides Support Tools for Caregivers. [2021]