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

Primary Purpose

Kidney Failure, Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facebook App
Live Donor Champion + Facebook App
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Failure focused on measuring Live Donor Transplant, Social Media, Education, Advocacy, Live Donor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting
  • Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Live Donor Champion + Facebook App

Facebook App

Standard of Care

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
knowledge of live donation
knowledge of live donation of transplant candidates will be collected during the survey.
comfort initiating conversations
comfort initiating conversations with others about live donation will be collected during the survey.

Full Information

First Posted
March 28, 2017
Last Updated
August 8, 2023
Sponsor
Johns Hopkins University
Collaborators
University of Alabama at Birmingham, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03099434
Brief Title
Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media
Acronym
ENGAGE
Official Title
Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 7, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Alabama at Birmingham, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Kidney Diseases
Keywords
Live Donor Transplant, Social Media, Education, Advocacy, Live Donor

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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).
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Live Donor Champion + Facebook App
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Facebook App
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care does not include any of the interventions detailed above, but rather normal routine care as this is the control group.
Intervention Type
Behavioral
Intervention Name(s)
Facebook App
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Live Donor Champion + Facebook App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live donor kidney transplantation
Description
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.
Time Frame
within 1 year of enrollment
Secondary Outcome Measure Information:
Title
Live Donor Inquiries
Description
Live Donor Inquiries on behalf of candidates will be the secondary outcome and will be collected/identified through electronic medical record system.
Time Frame
within 1 year of enrollment
Title
knowledge of live donation
Description
knowledge of live donation of transplant candidates will be collected during the survey.
Time Frame
within 6 months of enrollment
Title
comfort initiating conversations
Description
comfort initiating conversations with others about live donation will be collected during the survey.
Time Frame
within 6 months of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Cameron, MD PhD
Phone
410-349-7240
Email
acamero5@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Komal Kumar, MPH
Phone
347-628-2958
Email
kkumar8@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Cameron, MD PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Gordon, PhD MPH
Phone
312-503-5563
Email
e-gordon@northwestern.edu
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Cameron, MD PhD
Phone
410-349-7240
Email
acamero5@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media

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