Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media (ENGAGE)

This pilot study will be a clinical trial to test the feasibility and effectiveness of an educational intervention and a mobile health intervention in adults with end stage renal disease (ESRD) who have not yet identified a potential live donor.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Diseases; Kidney Failure
• Intervention / Treatment: Behavioral: Live Donor Champion + Facebook App; Behavioral: Facebook App

Detailed Description

Transplant candidates are hesitant to discuss their illness and the difficulties associated with dialysis, and are therefore reluctant to pursue live donor kidney transplant (LDKT). The investigators will conduct a prospective 3-arm randomized controlled trial with two novel interventions to increase live donation. Arm 1 includes LDC program and the Facebook app, Arm 2 includes just the Facebook app, and Arm 3 includes standard of care. The investigators primary objective is to demonstrate the the effectiveness of these interventions in increasing live donor transplantation rates for candidates with no prior potential live donor.

• Study Type: Interventional
• Enrollment (Actual): 775
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Cameron, MD PhD; Phone Number: 410-349-7240; Email: acamero5@jhmi.edu
• Study Contact Backup: Name: Komal Kumar, MPH; Phone Number: 347-628-2958; Email: kkumar8@jhu.edu

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Kidney transplant candidates aged≥18 added to the waitlist in the last year with no potential live donors are eligible.
• 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 trial and may still benefit from identification of new donors or increased comfort accepting donation from others.
• Participants at Johns Hopkins University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.

Exclusion Criteria:

• Candidates with live donors currently under evaluation for donation will be excluded.
• Those with a previous kidney transplant will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Live Donor Champion + Facebook App; The LDC program 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. At session 3, the the Facebook app will be incorporated and given to candidates. The Facebook app provides step-by-step instructions for creating a Facebook post that details each waitlist candidate's struggle with ESRD and their need for a live donor. The post is then uploaded to Facebook so it can be shared with the candidate's Facebook social network.	Behavioral: Live Donor Champion + Facebook App; A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in their pursuit of live donation. The investigators have developed a six-month program that provides education and advocacy training to waitlist candidates and their LDCs.
Active Comparator: Facebook App; The Facebook app provides step-by-step instructions for creating a Facebook post that details each waitlist candidate's struggle with ESRD and their need for a live donor. The post is then uploaded to Facebook so it can be shared with the candidate's Facebook social network. The Facebook App prompts users with specific questions to create a narrative. Links to supplemental resources are auto-populated into the post to provide anyone that views the post with vetted information about the risks, benefits, and process of live donation. Candidates using the Facebook app attend one focus group session held at the transplant center where they are provided with verbal instructions and visual demonstrations of installation and use of the Facebook app.	Behavioral: Facebook App; This web-based mobile application allows candidates to write a simple and effective story to share with their previously built network on Facebook to help share their story and identify a potential live donor.
No Intervention: Standard of Care; Standard of Care does not include any of the interventions detailed above, but rather normal routine care as this is the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live donor kidney transplantation	Live donor kidney transplantation within one year of enrollment into the study will be the primary outcome and will be collected/identified through electronic medical record system.	within 1 year of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live Donor Inquiries	Live Donor Inquiries on behalf of candidates will be the secondary outcome and will be collected/identified through electronic medical record system.	within 1 year of enrollment
knowledge of live donation	knowledge of live donation of transplant candidates will be collected during the survey.	within 6 months of enrollment
comfort initiating conversations	comfort initiating conversations with others about live donation will be collected during the survey.	within 6 months of enrollment

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University; University of Alabama at Birmingham
• Investigators: Principal Investigator: Andrew Cameron, MD PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Estimated): July 7, 2024
• Study Completion (Estimated): July 7, 2024

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Live Donor Transplant, Social Media, Education, Advocacy, Live Donor
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency
• Other Study ID Numbers: IRB00125128; R01DK111966 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No