Live Donor Champion Program for Kidney Disease

(LDC Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Live donors under evaluation, previous transplant

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

Compensation: Varies

Number of Visits: 6

111 Participants Needed

Trial Summary

What is the purpose of this trial?

The Live Donor Champion Program is a clinical education program offered to patients placed on the waitlist for kidney transplantation at the Johns Hopkins Comprehensive Transplant Center. The goal of the program is to increase patient knowledge regarding end stage renal disease, kidney transplantation, and live kidney donation and to help patients identify potential live kidney donors. Patients are encouraged to bring family and friends to participate in the program and act as advocates on their behalf. These friends and family members are labeled "live donor champions" and work to assist the patient in spreading awareness about end stage renal disease, kidney transplantation, and live kidney donation. The objectives of this project are to pilot-test and optimize strategies for the dissemination of the Live Donor Champion program in the clinical transplant center setting. The goals of the study are to develop an implementation protocol for centers who want to establish a live donor champion program at their institution.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems to focus on education and support rather than medical treatment, so you likely won't need to change your medications.

What data supports the effectiveness of the treatment Live Donor Champion Program for Kidney Disease?

The research shows that living donor kidney transplants lead to better survival rates for the transplanted kidney and improved life expectancy and quality for patients compared to other treatments. This suggests that programs supporting living donor transplants, like the Live Donor Champion Program, could be effective in improving outcomes for kidney disease patients. ^{1 2 3 4 5}

Is the Live Donor Champion Program for Kidney Disease safe for participants?

Living kidney donation is generally safe, with few short-term complications and minimal long-term health issues. However, there is a slightly increased risk of kidney disease and other health concerns, especially for certain groups, like black donors. ^{6 7 8 9 10}

How is the Live Donor Champion Program for Kidney Disease different from other treatments?

The Live Donor Champion Program is unique because it focuses on encouraging and supporting living kidney donations, which is considered the best treatment for chronic kidney disease. It involves a dedicated advocate to ensure the donor's rights and safety, separate from the recipient's healthcare team, to avoid conflicts of interest. ^{4 11 12 13 14}

Research Team

Elizabeth King, MD PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 on the kidney transplant waitlist within the last year without live donors. It's open to English speakers at University or University of Alabama, and English or Spanish speakers at Northwestern University. Friends or family willing to advocate for patients can join as 'Live Donor Champions'. Those with potential donors under evaluation or previous transplants are excluded.

Inclusion Criteria

I am over 18, need a kidney transplant, and have no live donors.

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

You are a friend, family member, or community member willing to speak up for the patient on the waiting list.

Exclusion Criteria

Candidates with live donors currently under evaluation for donation will be excluded.

Those with a previous kidney transplant will be excluded

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants and their Live Donor Champions attend 6 monthly sessions focusing on education about ESRD, KT, LDKT, communication skills, exploring social networks, sharing stories, and building self-efficacy.

6 months

6 visits (in-person)

Follow-up

Participants are monitored for the sustainability, penetration, acceptability, feasibility, appropriateness, fidelity, adoption, and cost of the program.

2 years

Treatment Details

Interventions

• Live Donor Champion Program

Trial Overview The Live Donor Champion Program educates patients about kidney failure, transplantation, and finding live donors. The study tests how well this program works in a clinical setting by helping participants increase their knowledge and identify potential donors through support from friends and family acting as advocates.

Participant Groups

Group I: Live Donor Champion Experimental Treatment 1 Intervention

The Live Donor Champion program is the sole educational intervention for this trial. LDC consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy 6) Program Recap.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Results of renal transplantation using kidneys harvested from living donors at the University of Heidelberg. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Process control: simply a matter of efficiency or of survival and costs? A single-centre quality improvement project in living donor renal transplant. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Outcomes of Living Kidney Donation from Medically Complex Donors: Implications for the Donor and the Recipient. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

[Living donor kidney transplant: the role of the nephrologist]. [2012]

5. China pubmed.ncbi.nlm.nih.gov

Characteristics and clinical outcomes of living renal donors in Hong Kong. [2018]

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

Cardiovascular disease and hypertension risk in living kidney donors: an analysis of health administrative data in Ontario, Canada. [2009]

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

Living kidney donors: current state of affairs. [2009]

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

Comorbidity burden and perioperative complications for living kidney donors in the United States. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Long-term medical risks to the living kidney donor. [2022]

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

Risks of Living Kidney Donation: Current State of Knowledge on Outcomes Important to Donors. [2023]

11. Denmark pubmed.ncbi.nlm.nih.gov

Medical outcomes of adolescent live kidney donors. [2019]

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

Living kidney donor advocacy program: a quality improvement project. [2012]

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

Long-term consequences of kidney donation. [2022]

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

The Independent Living Donor Advocate: An Essential Role for Living Kidney Donation. [2015]