- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599102
Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase (LOVED)
May 14, 2021 updated by: Medical University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
No Intervention: Standard Care
Standard interaction with transplant center and physician care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed at 8 weeks
|
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. |
Change between 0 and 8 weeks and change between 0 and 6 months
|
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.
|
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
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
|
Change between 0 and 8 weeks and change between 0 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
8 weeks, 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
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).
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frank A Treiber, PhD, Medical University of South Carolina
- Principal Investigator: Baliga Baliga, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
December 1, 2016
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
May 18, 2021
Last Update Submitted That Met QC Criteria
May 14, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Pro00031456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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