Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media (ENGAGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03099434|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure Kidney Diseases||Behavioral: Facebook App Behavioral: Live Donor Champion + Facebook App||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1350 participants|
|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)|
|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|
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.
- 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.
- 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.
- knowledge of live donation [ Time Frame: within 6 months of enrollment ]knowledge of live donation of transplant candidates will be collected during the survey.
- comfort initiating conversations [ Time Frame: within 6 months of enrollment ]comfort initiating conversations with others about live donation will be collected during the survey.
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
|Contact: Andrew Cameron, MD PhDfirstname.lastname@example.org|
|Contact: Komal Kumar, MPHemail@example.com|
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|Contact: Elisa Gordon, PhD MPH 312-503-5563 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21218|
|Contact: Andrew Cameron, MD PhD 410-349-7240 email@example.com|