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

Kidney Diseases Clinical Trial

— PILOT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05468463
• Other study ID #: IRB-300002556
• Secondary ID: R01DK125509
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 440
• Est. completion date: February 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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