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

NCT03599102 | Completed

• 1 other identifier: Pro00031456
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Participant adherence to study protocols

  Tolerability as defined by % retention to study (% of participants who self-remove from the study) Fidelity as defined by %adherence to chat sessions and completion %of video modules.

  Assessed at 8 weeks

• Change in knowledge about living donation

  Score measures for self-efficacy, knowledge and attitudes to approach others to be a living donor -LDKT Knowledge Scale (knowledge) (15 item T/F); each correct response adds 1 point. 0-15 range with higher numbers represent higher knowledge.

  Change between 0 and 8 weeks and change between 0 and 6 months

• Change in attitudes on living donation

  LDKT Concerns Scale (i.e., measuring attitudes) (21 T/F with one point for each statement suggestive of more worry); 0-21 range with higher results representing more concerns about LDKT.

  Change between 0 and 8 weeks and change between 0 and 6 months

• Change in self-efficacy to ask others to be a living donor

  Willingness to Discuss LDKT Scale (i.e., measuring self-efficacy (SE)) (1 item each for family, friends, and strangers7 pt. Likert scale) 1-7 range with higher values representing higher SE to approach others about living donation

  Change between 0 and 8 weeks and change between 0 and 6 months

Secondary Outcomes (1)

• Completing living donor kidney transplantation

  8 weeks, 6 months

Other Outcomes (4)

• Assessment of making autonomous decisions

  8 weeks

• Assessment of feelings of trust

  8 weeks

• Assessment of cultural competency

  8 weeks

Study Arms (2)

LOVED intervention

EXPERIMENTAL

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.

Behavioral: LOVED Intervention

Standard Care

NO INTERVENTION

Standard interaction with transplant center and physician care.

Interventions

LOVED Intervention BEHAVIORAL

LOVED intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or less on the kidney waitlist with active status including pre-emptive and ESRD patients on dialysis
• years or less on dialysis

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Frank A Treiber, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Baliga Baliga, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: July 26, 2018
• Study Start: August 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)