Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase

NCT ID: NCT03599102

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-28

Brief Summary

LOVED stands for the Living Organ Video Educated Donors (LOVED) program. It is a culturally tailored program for African Americans to reduce the disparity of low rates of living kidney donation. It is a mobile health delivered platform that does not require transplant center visits, thus increasing the reach of the program compared to center-based program to enhance living kidney donation. The purpose of LOVED is to give education and encouragement to those who need a kidney transplant and teach about the process of living donation to be better educated when approaching others about donating a kidney. The ultimate goal of the program is to increase the number of living kidney donor transplants, especially among African Americans in South Carolina. The program was created to educate those in need of a kidney about the donor process, to dispel myths about living donation, discuss who can be asked to donate and develop and practice skills to start asking others for a living kidney donation. The program is designed to be completed using a tablet computer and is made up of weekly video education clips, resources, short quizzes to reinforce the learning points and weekly video chat sessions with others who need a kidney led by a "navigator" who was once a living donor kidney recipient. The video clips are made up of stories and brief educational messages from transplant center staff, physicians, former donors and recipients. The video chat sessions were designed to solve and address individual issues for those enrolled in the program and to give a sense of community as they continue on their journey to find a kidney. This randomized control trial uses groups of 6-9 participants in each LOVED group that lasts 8-weeks each. A total of 60 participants will be recruited with 30 assigned to LOVED and 30 assigned to a standard care groups. This program is funded by a grant from the National Institute of Health and was developed at the Medical University of South Carolina.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

LOVED intervention

Intervention group receives the LOVED program, an 8-week program where participants receive video education modules, and weekly video chat sessions with other end-stage renal disease patients and a prior living kidney African American recipient. The program aims to increase knowledge and skills on how to promote individual strategies on how to ask for a kidney from others.

Group Type: EXPERIMENTAL

LOVED Intervention

Intervention Type: BEHAVIORAL

Standard Care

Standard interaction with transplant center and physician care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LOVED Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-65 years old
• African American
• Legally competent
• Able to read and speak in English
• Able to use tablet computers (after instruction)
• Able to use cell phone
• 5 years or less on the kidney waitlist with active status including pre-emptive and ESRD patients on dialysis
• 10 years or less on dialysis

Exclusion Criteria

• Patients who have currently identified PDs moving through the evaluation stage

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank A Treiber, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Baliga Baliga, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00031456

Identifier Type: -

Identifier Source: org_study_id