Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media

Kidney Diseases Clinical Trial

— ENGAGE  

Official title:

Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03099434
• Other study ID #: IRB00125128
• Secondary ID: R01DK111966
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: July 7, 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 775
• Est. completion date: July 7, 2024
• Est. primary completion date: July 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure
• Renal Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern University	Evanston	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	knowledge of live donation	knowledge of live donation of transplant candidates will be collected during the survey.	within 6 months of enrollment
Secondary	comfort initiating conversations	comfort initiating conversations with others about live donation will be collected during the survey.	within 6 months of enrollment