End Stage Liver DiseaseLLDCNCT03580629
Pilot Study of the Liver Live Donor Champion Program
A study testing Liver Live Donor Champion Program in people with End Stage Liver Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this pilot study, investigators plan to enroll liver transplant candidates and a "Live Donor Champion" for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Liver Live Donor Champion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 29 Nov 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active candidate on the liver transplant waitlist.
- Have no potential living donors at the time of study enrollment.
- Have not had a previous transplant
- be 18 years or older
- be English speaking
- Mentally capable of providing informed consent
Who cannot join
- Age less than 18 years old
- Has potential live donor candidates
- non-English speaking
- Previous liver transplant
- Listed for multiple organs
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University
Baltimore, Maryland, 21218
About this study
In this pilot study, investigators plan to enroll liver transplant candidates and a "Live Donor Champion" for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Investigators have created two versions of the same program and based on feedback from participants and staff, investigators aim to analyze the efficacy of the Liver Liver Donor Champion program on this patient population.
Read the detailed description
In the United States, more than 13,000 patients are on the waiting list to receive a liver transplant. Although more than 6,000 liver transplants are performed every year, at least 1,700 patients die each year while on the waiting list. Livers are allocated to patients based on how sick the participants are, with sicker patients receiving priority.
Living donation offers patients the option of transplant before patients get very sick, significantly decreasing the time patients wait for a liver. Livers from living donors are usually of excellent quality because donors are evaluated extensively and only allowed to donate if patients are in very good health. Living donation not only saves the life of the liver transplant candidate but also frees up a liver for a patient on the waiting list who does not have that option.
A number of studies have attempted to understand barriers to finding a living donor. Multiple surveys have suggested that the educational needs are not met for both transplant candidates and potential donors. Furthermore, lack of knowledge and understanding of the consequences of donation may aggravate candidate fear of donor risks, contributing to candidate reluctance in allowing friends or family to donate. Finally, having an inadequate communication skill set in how to ask someone to donate is one of the most prevalent barriers reported by transplant candidates.
A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in participants' pursuit of living donation. Investigators' center has previously developed a six-month program that provides education and advocacy training to kidney transplant candidates and participants' LDCs; however, no program currently exists for liver transplant candidates.
The instrumental support provided by the LDC from investigators' kidney program bridges a critical link between education and action. In pilot studies, candidates with an LDC were more likely to undergo live donor kidney transplantation than matched controls.
In this pilot study, investigators plan to enroll liver transplant candidates and participants' LDCs for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Investigators have created two versions of the same program and based on feedback from participants and staff, investigators aim to analyze the efficacy of the Liver Liver Donor Champion program on this patient population.
- Conditions
- End Stage Liver Disease
- Being tested
- Liver Live Donor Champion Program
- Keywords
- Live Donor Liver Transplant, Education, Advocacy, Live Donor Champion
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Live Donor Champion ProgramBehavioural
Also called LLDC program
Even with adequate education of live donation, many liver transplant candidates still feel ill equipped to ask others to consider donating. Friends and family are often eager to help and may not be able to serve as donors themselves, but might be able to provide instrumental support. A Live Donor Champion (LDC) is a friend or family member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed the Liver Live Donor Champion program to provide education and advocacy training to waitlist candidates and their LDCs. The support provided by the LDC bridges a critical link between education and action. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm.
| Study group | Role | What they receive |
|---|---|---|
| Liver Live Donor Champion | Experimental | The Liver Live Donor Champion program (LLDC) is the sole educational intervention for this trial. LLDC consists of 2 or 3 monthly sessions (depending on cohort) of approximately 2 or 3 hours each. Each LLDC session is led by a transplant physician or clinical coordinator. The sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LLDC session topics are as follows: 1) education about End-Stage Liver Disease (ESLD), liver transplantation, and living donation 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) surgeon and hepatologist panel 6) Program Recap. Receives: Behavioral: Liver Live Donor Champion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Donor Inquiries
Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical system.
Measured: within 2 year of enrollment
Live Donor Liver Transplantation
Live Donor Liver Transplantation within one year of enrollment into the study will be collected/identified through electronic medical record system.
Measured: within 2 year of enrollment
Secondary outcomes (3)
Knowledge of live donation and liver transplantation
Knowledge of live donation and liver transplantation will be collected during participant surveys.
Measured: within 6 months of enrollment
Comfort initiating conversations
Comfort initiating conversations with others about live donation will be collected during participant surveys.
Measured: within 6 months of enrollment
Feasibility - Implementation Outcome
Feasibility is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Feasibility will be assessed qualitatively by recording reflections of the implementing study team.
Measured: within 2 year of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start18 Sep 2018
- Primary completion28 Nov 2025
- Study completion29 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth A King, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580629
- Sponsor's protocol ID
- IRB00170784
- Acronym
- LLDC
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2018
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Liver Live Donor Champion Program
- ClinicalTrials.gov ID
- NCT03580629
- Acronym / sponsor ID
- LLDC / IRB00170784
- Conditions
- End Stage Liver Disease
- Keywords
- Live Donor Liver Transplant, Education, Advocacy, Live Donor Champion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 9 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.
In this pilot study, investigators plan to enroll liver transplant candidates and a "Live Donor Champion" for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Investigators have created two versions of the same program and based on feedback from participants and staff, investigators aim to analyze the efficacy of the Liver Liver Donor Champion program on this patient population.
Detailed description
In the United States, more than 13,000 patients are on the waiting list to receive a liver transplant. Although more than 6,000 liver transplants are performed every year, at least 1,700 patients die each year while on the waiting list. Livers are allocated to patients based on how sick the participants are, with sicker patients receiving priority.
Living donation offers patients the option of transplant before patients get very sick, significantly decreasing the time patients wait for a liver. Livers from living donors are usually of excellent quality because donors are evaluated extensively and only allowed to donate if patients are in very good health. Living donation not only saves the life of the liver transplant candidate but also frees up a liver for a patient on the waiting list who does not have that option.
A number of studies have attempted to understand barriers to finding a living donor. Multiple surveys have suggested that the educational needs are not met for both transplant candidates and potential donors. Furthermore, lack of knowledge and understanding of the consequences of donation may aggravate candidate fear of donor risks, contributing to candidate reluctance in allowing friends or family to donate. Finally, having an inadequate communication skill set in how to ask someone to donate is one of the most prevalent barriers reported by transplant candidates.
A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in participants' pursuit of living donation. Investigators' center has previously developed a six-month program that provides education and advocacy training to kidney transplant candidates and participants' LDCs; however, no program currently exists for liver transplant candidates.
The instrumental support provided by the LDC from investigators' kidney program bridges a critical link between education and action. In pilot studies, candidates with an LDC were more likely to undergo live donor kidney transplantation than matched controls.
In this pilot study, investigators plan to enroll liver transplant candidates and participants' LDCs for an abridged two- or three-month program that provides education and advocacy training in order to expand access to live donor liver transplantation. Investigators have created two versions of the same program and based on feedback from participants and staff, investigators aim to analyze the efficacy of the Liver Liver Donor Champion program on this patient population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Live Donor Champion | Experimental | Behavioral: Liver Live Donor Champion ProgramThe Liver Live Donor Champion program (LLDC) is the sole educational intervention for this trial. LLDC consists of 2 or 3 monthly sessions (depending on cohort) of approximately 2 or 3 hours each. Each LLDC session is led by a transplant physician or clinical coordinator. The sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LLDC session topics are as follows: 1) education about End-Stage Liver Disease (ESLD), liver transplantation, and living donation 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) surgeon and hepatologist panel 6) Program Recap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active candidate on the liver transplant waitlist.
- Have no potential living donors at the time of study enrollment.
- Have not had a previous transplant
- be 18 years or older
- be English speaking
Key exclusion criteria (5 listed)
- Age less than 18 years old
- Has potential live donor candidates
- non-English speaking
- Previous liver transplant
- Listed for multiple organs
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 |
|---|---|---|
| Liver Live Donor Champion ProgramAlso: LLDC programEven with adequate education of live donation, many liver transplant candidates still feel ill equipped to ask others to consider donating. Friends and family are often eager to help and may not be able to serve as donors themselves, but might be able to provide instrumental support. A Live Donor Champion (LDC) is a friend or family member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed the Liver Live Donor Champion program to provide education and advocacy training to waitlist candidates and their LDCs. The support provided by the LDC bridges a critical link between education and action. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm. | Behavioural | Liver Live Donor Champion |
Primary outcome
Live Donor Inquiries
Time frame: within 2 year of enrollment
Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical system.
Live Donor Liver Transplantation
Time frame: within 2 year of enrollment
Live Donor Liver Transplantation within one year of enrollment into the study will be collected/identified through electronic medical record system.
3 secondary outcomes
Knowledge of live donation and liver transplantation
Time frame: within 6 months of enrollment
Comfort initiating conversations
Time frame: within 6 months of enrollment
Feasibility - Implementation Outcome
Time frame: within 2 year of enrollment
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 22 Dec 2025.
- 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.
Elizabeth A King, MD PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Live Donor Champion Program in people with End Stage Liver Disease, run by Johns Hopkins University 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 6 inclusion and 5 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 22 Dec 2025. 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?
Live Donor Inquiries (time frame: within 2 year of enrollment). The study lists 2 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 22 Dec 2025.