Increasing Kidney Transplant Among Blacks on the Transplant Waiting List

NCT02319447 | Completed DMC

• 2 other identifiers: SBMC 2012-69R01DK098744
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

For most patients with kidney failure, living donor kidney transplant (LDKT) is their best treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney failure but less likely to receive LDKTs. In this study, the investigators will test an intervention designed to address this disparity, by performing a parallel group, two-arm randomized clinical trial among 500 Black kidney transplant candidates. The main objective of this study is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among transplant candidates (persons active on the deceased donor kidney transplant waiting list) who are Black. Our overall hypothesis is that a multi-component intervention administered to Black transplant candidates will increase both readiness to pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign kidney transplant candidates on the kidney transplant waiting list to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a group-based intervention, as well as monthly mailings and a follow-up phone call by a transplant educator.

Conditions

Chronic Kidney Disease; End-Stage Renal Disease

Keywords

Living Donation; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Change in readiness to pursue LDKT at 9 months

  Our primary outcome is the proportion of study participants with an increase in their readiness to pursue LDKT. Readiness to pursue LDKT is assessed by the patient's Stage of Change regarding pursuing live donation, based upon James Prochaska's Transtheoretical Model. The Stages of Change regarding pursuit of living donation include: not considering (Pre-contemplation), considering (Contemplation), preparing to pursue (Preparation), or taking action to pursue (Action) living donation within the next 6 months. Stage of Change will be assessed at baseline and at 9 months post-baseline.

  Baseline, 9 months

Secondary Outcomes (4)

• Receipt of a LDKT

  18 months

• Number of donor volunteers recruited and evaluated

  18 months

• Status on kidney transplant waiting list

  18 months

• Change in knowledge of LDKT at 9 months

  Baseline, 9 months

Other Outcomes (2)

• Change in knowledge of LDKT at 1 week post-intervention

  Baseline, 1 week post-intervention

• Change in readiness to pursue LDKT at 1 week post-intervention

  Baseline, 1 week post-intervention

Study Arms (2)

Usual Care

NO INTERVENTION

After randomization, these study participants will receive the Usual Care received by all listed kidney transplant candidates at our center.

Additional education

EXPERIMENTAL

These study participants will be invited to attend a 60-90 minute educational seminar, entitled Destination: Transplant, delivered in a group setting. They will also receive monthly mailings for 9 months and a follow-up phone call from a transplant educator.

Behavioral: Additional education

Interventions

Additional education BEHAVIORAL

Our Intervention includes a 60-90 minute educational seminar, entitled "Destination: Transplant", featuring "live" speakers, delivered to small groups of Black kidney transplant candidates and their family and friends. Topics include: 1) basic facts about Chronic Kidney Disease (CKD), transplant, and the waiting list; 2) the experience of receiving a LDKT transplant (by a Black LDKT recipient); 3) the experience of serving as a living kidney donor (by a Black living kidney donor); and 4) strategies to increase the chances of getting a transplant sooner. Participants receive monthly mailed, written information for 9 months and a follow-up phone call from a transplant educator, 3 months after attending the seminar.

Additional education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported as Black or African-American
• years of age or older
• active on kidney transplant waiting list at Saint Barnabas Medical Center

You may not qualify if:

• limited English proficiency
• unable or unwilling to provide informed consent
• unable to complete in-person and telephone questionnaires (including hearing impairment or low vision)
• lack a working telephone
• live 150 miles or greater from transplant center
• enrolled in prior randomized intervention trial, NCT01261910, at our center
• currently already scheduled to receive a live donor kidney transplant
• active on the simultaneous pancreas-kidney transplant waiting list

Sponsors & Collaborators

• St. Barnabas Medical Center: lead
• University of California, Los Angeles: collaborator
• Rutgers University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis L Weng, MD, MSCE

  St. Barnabas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)