Clinical trial NCT03599102: Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase
Official title: Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Participant adherence to study protocols
timeFrame: Assessed at 8 weeks
measure: Change in knowledge about living donation
timeFrame: Change between 0 and 8 weeks and change between 0 and 6 months
measure: Change in attitudes on living donation
timeFrame: Change between 0 and 8 weeks and change between 0 and 6 months
measure: Change in self-efficacy to ask others to be a living donor
timeFrame: Change between 0 and 8 weeks and change between 0 and 6 months
Secondary outcomes:
measure: Completing living donor kidney transplantation
timeFrame: 8 weeks, 6 months
Other outcomes:
measure: Assessment of making autonomous decisions
timeFrame: 8 weeks
measure: Assessment of feelings of trust
timeFrame: 8 weeks
measure: Assessment of cultural competency
timeFrame: 8 weeks
measure: Assessment of communication satisfaction
timeFrame: 8 weeks
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Frank A Treiber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Baliga Baliga, MD
role: PRINCIPAL_INVESTIGATOR
References: