NCT03099434

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
775

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Apr 2017Dec 2026

First Submitted

Initial submission to the registry

March 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2026

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

9.7 years

First QC Date

March 28, 2017

Last Update Submit

December 4, 2025

Conditions

Keywords

Live Donor Transplant, Social Media, Education, Advocacy, Live Donor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Live Donor Inquiries

    within 1 year of enrollment

  • knowledge of live donation

    within 6 months of enrollment

  • comfort initiating conversations

    within 6 months of enrollment

Study Arms (3)

Live Donor Champion + Facebook App

ACTIVE COMPARATOR

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

Facebook App

ACTIVE COMPARATOR

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

Standard of Care

NO INTERVENTION

Standard of Care does not include any of the interventions detailed above, but rather normal routine care as this is the control group.

Interventions

Facebook AppBEHAVIORAL

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.

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.

Live Donor Champion + Facebook App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Renal InsufficiencyKidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Andrew Cameron, MD PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Patients will be randomly assigned to one of the 3 arms, where arm 1 is two interventions combined (LDC program + Facebook app), arm 2 is one intervention (Facebook app), and arm 3 is the control group (standard-of-care).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

April 1, 2017

Primary Completion (Estimated)

December 7, 2026

Study Completion (Estimated)

December 7, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations