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Trial record 2 of 83 for:    "Living Donors" | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03099434
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborators:
University of Alabama at Birmingham
Northwestern University
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Kidney Failure Kidney Diseases Behavioral: Facebook App Behavioral: Live Donor Champion + Facebook App Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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: Double (Care Provider, Investigator)
Primary Purpose: Other
Official Title: Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Live donor kidney transplantation [ Time Frame: within 1 year of enrollment ]
    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 :
  1. Live Donor Inquiries [ Time Frame: within 1 year of enrollment ]
    Live Donor Inquiries on behalf of candidates will be the secondary outcome and will be collected/identified through electronic medical record system.

  2. knowledge of live donation [ Time Frame: within 6 months of enrollment ]
    knowledge of live donation of transplant candidates will be collected during the survey.

  3. comfort initiating conversations [ Time Frame: within 6 months of enrollment ]
    comfort initiating conversations with others about live donation will be collected during the survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099434


Contacts
Contact: Andrew Cameron, MD PhD 410-349-7240 acamero5@jhmi.edu
Contact: Komal Kumar, MPH 347-628-2958 kkumar8@jhu.edu

Locations
United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Elisa Gordon, PhD MPH    312-503-5563    e-gordon@northwestern.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Andrew Cameron, MD PhD    410-349-7240    acamero5@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
University of Alabama at Birmingham
Northwestern University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03099434     History of Changes
Other Study ID Numbers: RDK111966A
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Live Donor Transplant, Social Media, Education, Advocacy, Live Donor

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases