House Calls and Peer Mentorship

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2022-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment assignments will be based on a computer-generated randomization scheme, stratified by age (\<60 vs. ≥60 yrs old) and household income (\<250% vs. ≥250% of federal poverty guidelines), since older and low-income patients are known to have lower LDKT rates a priori. Patients will be randomized into one of three treatment arms in a 1:3:3 fashion such that 54 Usual Care, 160 HC and 160 HC+PM patients will be enrolled. The study investigators and research assistants conducting the study assessments of patients will remain blinded to the treatment assignments. KT candidates will be informed of group assignment immediately after completing the Baseline assessment.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual Care

All enrolled patients will receive Usual Care for transplant candidates at our two centers, which includes individual meetings with transplant providers, attendance at a patient group education session in the transplant center (focused on the specifics of the transplant experience), and a transplant education binder.

Group Type NO_INTERVENTION

No interventions assigned to this group

Usual Care (UC) + House Calls (HC)

Patients and their invited guests will be scheduled for one House Call. A house call is meeting done at a patient's home with transplant health educators facilitating a discussion on topics related to living kidney donation. Patients and guests also receive an information packet containing several brochures providing information about the living donation process, common concerns and misperceptions, and donation resources and information about our transplant center (e.g., copy of our quarterly newsletter, contact information). Patients in the group will also receive Usual Care, the regular education on living donation, provided as part of their routine transplant care.

Group Type ACTIVE_COMPARATOR

House Call

Intervention Type BEHAVIORAL

60 to 90 minute home based educational intervention which will be administered by a health educator.

UC + HC + Peer Mentorship

Patients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call.

Group Type EXPERIMENTAL

House Call

Intervention Type BEHAVIORAL

60 to 90 minute home based educational intervention which will be administered by a health educator.

Peer Mentorship

Intervention Type BEHAVIORAL

A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.

Interventions

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House Call

60 to 90 minute home based educational intervention which will be administered by a health educator.

Intervention Type BEHAVIORAL

Peer Mentorship

A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No