House Calls and Peer Mentorship

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; End-Stage Renal Disease

• Registration Number: NCT03354910
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-28
• Study Start: 2018-04-30
• Primary Completion: 2021-03-31
• Study Completion: 2022-12-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Black race (including possible Cape Verdean, Haitian, Dominican)
• ≥18 yrs old
• English speaking
• Meets eligibility criteria for kidney transplant evaluation
• Ability to provide informed consent
• Resides within 1.5 hr drive of HC educator

Exclusion Criteria

• Temporarily Unavailable (TU) on the waiting list and TU is likely to exceed 6 months based on judgement of kidney transplant team
• Awaiting combined kidney-liver transplantation
• Awaiting simultaneous pancreas-kidney transplantation
• Participation in another study to increase the likelihood of LDKT
• Prior participation in a transplant HC
• Prior or current participation in the NKF PM program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Live donor kidney transplants	1 Year Post-Intervention	The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.

Secondary Outcome Measures

Name	Time	Method
Live donor evaluations	1 Year Post-Intervention	A secondary outcome for the study is the proportion of enrolled patients with a live donor evaluation at the one-year endpoint. A live donor evaluation is defined as the completion of a transplant evaluation to determine whether a potential living donor is eligible to donate.
Live donor inquiries	1 Year Post-Intervention	A secondary outcome for the study is proportion of enrolled patients with live donor inquiries at the one-year endpoint. A live donor inquiry is when an individual contacts the transplant center to express interest in living donation, regardless of when they complete the entire live donor evaluation.

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States