Skip to main content
OpenTrials
Completed

NCT Number: NCT03599102

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOVED Intervention

Behavioral

Primary outcomes

  1. Participant adherence to study protocols

    Time frame: Assessed at 8 weeks

    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.

  2. Change in knowledge about living donation

    Time frame: Change between 0 and 8 weeks and change between 0 and 6 months

    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.

  3. Change in attitudes on living donation

    Time frame: Change between 0 and 8 weeks and change between 0 and 6 months

    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.

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

    Time frame: Change between 0 and 8 weeks and change between 0 and 6 months

    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

Secondary outcomes

  1. Completing living donor kidney transplantation

    Time frame: 8 weeks, 6 months

    % who identify potential donors, % elected to be screened and, % completing Living donor kidney transplantation (from clinical records compared between groups)

Other outcomes

  1. Assessment of making autonomous decisions

    Time frame: 8 weeks

    Shared Decision Making Questionnaire (SDM-Q-9), a 6 question 4-item Likert scale (1=strongly agree to 4=strongly disagree) involved decision making between the participant and Loved Navigator. Questions were averaged (range 1-4). Lower scores represent better ability to make decisions.

  2. Assessment of feelings of trust

    Time frame: 8 weeks

    Assess if the participant feels distrust of study staff, and medical providers during after the trial. Abbreviated Trust Measure, 3 question, 4-item Likert scale between participant and navigator. Question scores were averaged where higher scores indicated more trust (range 1-4).

  3. Assessment of cultural competency

    Time frame: 8 weeks

    Assess feelings of inclusion based on race during study process. Experiences of Discrimination, a 5 question, 4-tem Likert scale. Questions were averaged (range 1-4). Higher sum scores represent higher trust perceptions.

  4. Assessment of communication satisfaction

    Time frame: 8 weeks

    Assess feelings of how the communication was administrated during the study. Communication Effectiveness Questionnaire, a 9 question 5-item Likert scale between the participant and the navigator, research staff and renal transplant team. Questions were averaged (range 1-4). Higher sum scores represent higher communication perceptions.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: LOVED

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.