Kidney TransplantationLOVEDNCT03599102
Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase
A study testing LOVED Intervention in people with Kidney Transplantation, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- LOVED Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have currently identified PDs moving through the evaluation stage
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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
- Being tested
- LOVED Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOVED InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: LOVED Intervention |
| Standard Care | No intervention | Standard interaction with transplant center and physician care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change between 0 and 8 weeks and change between 0 and 6 months
Secondary outcomes (1)
Completing living donor kidney transplantation
% who identify potential donors, % elected to be screened and, % completing Living donor kidney transplantation (from clinical records compared between groups)
Measured: 8 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startAug 2016
- Primary completionApr 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank A Treiber, PhD, Principal investigator, Medical University of South CarolinaBaliga Baliga, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599102
- Sponsor's protocol ID
- Pro00031456
- Acronym
- LOVED
- Status last verified
- May 2021
- First submitted
- 1 Dec 2016
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase
- ClinicalTrials.gov ID
- NCT03599102
- Acronym / sponsor ID
- LOVED / Pro00031456
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOVED intervention | Experimental | Behavioral: LOVED InterventionIntervention 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. |
| Standard Care | No intervention | –Standard interaction with transplant center and physician care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years old
- African American
- Legally competent
- Able to read and speak in English
- Able to use tablet computers (after instruction)
Key exclusion criteria (1 listed)
- Patients who have currently identified PDs moving through the evaluation stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOVED Intervention | Behavioural | LOVED intervention |
Primary outcome
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.
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 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 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
1 secondary outcome
Completing living donor kidney transplantation
Time frame: 8 weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A Treiber, PhD principal investigator
Medical University of South Carolina
Baliga Baliga, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOVED Intervention in people with Kidney Transplantation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant adherence to study protocols (time frame: Assessed at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.