End-stage Renal DiseaseLDCNCT03435510
Implementation of the Live Donor Champion Program
A study testing Live Donor Champion Program in people with End-stage Renal Disease, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The Live Donor Champion Program is a clinical education program offered to patients placed on the waitlist for kidney transplantation at the Johns Hopkins Comprehensive Transplant Center. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- 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
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2018to 30 Apr 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kidney transplant candidates aged≥18 added to the waitlist in the last year with no potential live donors are eligible.
- If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the trial and may still benefit from identification of new donors or increased comfort accepting donation from others.
- Participants at University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.
Who cannot join
- Candidates with live donors currently under evaluation for donation will be excluded.
- Those with a previous kidney transplant will be excluded
- Live Donor Champions Inclusion Criteria
- aged≥18
- English-speaking
- Be a "Live Donor Champion" (a friend, family member or community member willing to advocate for the wait-listed patient).
Show all 12Show fewer
- <18, not English-speaking
- LDC Administrators Inclusion Criteria
- aged≥18
- English-speaking
- Performed tasks related to implementing the LDC program
- <18, not English-speaking, and no affiliation with implementing the LDC program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
The Live Donor Champion Program is a clinical education program offered to patients placed on the waitlist for kidney transplantation at the Johns Hopkins Comprehensive Transplant Center. The goal of the program is to increase patient knowledge regarding end stage renal disease, kidney transplantation, and live kidney donation and to help patients identify potential live kidney donors. Patients are encouraged to bring family and friends to participate in the program and act as advocates on their behalf. These friends and family members are labeled "live donor champions" and work to assist the patient in spreading awareness about end stage renal disease, kidney transplantation, and live kidney donation.
The objectives of this project are to pilot-test and optimize strategies for the dissemination of the Live Donor Champion program in the clinical transplant center setting. The goals of the study are to develop an implementation protocol for centers who want to establish a live donor champion program at their institution.
Read the detailed description
Live Donor Champion Concept: Even with adequate education of live donation, many kidney 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 substantial instrumental support. A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed a six-month program that provides education and advocacy training to waitlist candidates and their LDCs. The instrumental support provided by the LDC bridges a critical link between education and action. In pilot studies, candidates with an LDC were more likely to undergo Live Donor Kidney Transplant (LDKT) than matched controls. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm, including support from United Network for Organ Sharing.
Live Donor Champions (LDCs) as Instrumental Support for Transplant Candidates. Approaching potential donors is a daunting and overwhelming experience for Kidney Transplant (KT) candidates. Current educational programs address the medical aspects of dialysis, KT, and donation, but neglect the health communication skills to discuss transplantation and to spread awareness through their various social networks. While transplant candidates are hesitant to engage others in conversations about End Stage Renal Disease (ESRD) and live donation, friends, family members, or community members are eager to spread awareness and provide advocacy for the patient. In pilot studies, this intervention improved knowledge regarding LDKT and provided instrumental support to the transplant candidates. Understanding what factors are associated with the successful implementation of this program will enable its eventual dissemination at transplant centers nationwide ultimately improving nationwide education and awareness of LDKT. In order to successfully do so, a scientifically rigorous implementation study is necessary.
- Conditions
- End-stage Renal Disease
- Being tested
- Live Donor Champion Program
- Keywords
- Live Donor Kidney Transplant, Education, Advocacy, Live Donor
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Donor Champion ProgramBehavioural
Also called LDC Program
Even with adequate education of live donation, many KT 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 substantial instrumental support. An 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 a 6-month program that provides education and advocacy training to waitlist candidates and their LDCs. The instrumental 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 |
|---|---|---|
| Live Donor Champion | Other | The Live Donor Champion program is the sole educational intervention for this trial. LDC consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy 6) Program Recap. Receives: Behavioral: Live Donor Champion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability - Implementation Outcome
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Acceptability will be measured qualitatively using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Measured: within 2 years of enrollment
Adoption - Implementation Outcome
Adoption is defined as the intention or action to employ an innovation or practice. Adoption will be measured qualitatively using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Measured: within 2 years of enrollment
Appropriateness - Implementation Outcome
Appropriateness is a qualitative measure of the perceived fit, relevance, or compatibility of the innovation for a given setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue. We will measure program appropriateness using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Measured: within 2 years of enrollment
Cost - Implementation Outcome
Cost (incremental or implementation cost) is the cost impact of an implementation effort. Implementation cost will be assessed by estimations made during observational sessions of the intervention.
Measured: within 2 years 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 using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Measured: within 2 years of enrollment
Fidelity - Implementation Outcome
Fidelity is defined as the degree to which an intervention was implemented as prescribed in the original protocol or as it was intended by the developers. Fidelity will be qualitatively assessed using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Measured: within 2 years of enrollment
Penetration - Implementation Outcome
Penetration is the integration of a practice within a setting or subsystem. Penetration of the LDC program within our two sites will be measured by calculating the number of eligible persons who use a service, divided by the total number of eligible.
Measured: within 2 years of enrollment
Sustainability - Implementation Outcome
Sustainability is defined as the extent to which a newly implemented treatment is maintained or institutionalized within a service setting's ongoing, stable operations. Sustainability will be qualitatively assessed using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Measured: within 2 years of enrollment
Secondary outcomes (4)
Live donor kidney transplantation
Live donor kidney transplantation within one year of enrollment into the study will be collected/identified through electronic medical record system.
Measured: within 1 year of enrollment
Live Donor Inquiries
Live Donor Inquiries on behalf of candidates will be collected/identified through electronic medical record system.
Measured: within 1 year of enrollment
Knowledge of live donation and kidney transplantation
Knowledge of live donation of transplant candidates will be collected during the survey.
Measured: within 6 months of enrollment
Comfort initiating conversations
Comfort initiating conversations with others about live donation will be collected during the survey.
Measured: within 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start30 May 2018
- Primary completion30 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth King, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435510
- Sponsor's protocol ID
- IRB00161951
- Acronym
- LDC
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 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
- Implementation of the Live Donor Champion Program
- ClinicalTrials.gov ID
- NCT03435510
- Acronym / sponsor ID
- LDC / IRB00161951
- Conditions
- End-stage Renal Disease
- Keywords
- Live Donor Kidney Transplant, Education, Advocacy, Live Donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Feb 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.
The Live Donor Champion Program is a clinical education program offered to patients placed on the waitlist for kidney transplantation at the Johns Hopkins Comprehensive Transplant Center. The goal of the program is to increase patient knowledge regarding end stage renal disease, kidney transplantation, and live kidney donation and to help patients identify potential live kidney donors. Patients are encouraged to bring family and friends to participate in the program and act as advocates on their behalf. These friends and family members are labeled "live donor champions" and work to assist the patient in spreading awareness about end stage renal disease, kidney transplantation, and live kidney donation.
The objectives of this project are to pilot-test and optimize strategies for the dissemination of the Live Donor Champion program in the clinical transplant center setting. The goals of the study are to develop an implementation protocol for centers who want to establish a live donor champion program at their institution.
Detailed description
Live Donor Champion Concept: Even with adequate education of live donation, many kidney 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 substantial instrumental support. A "Live Donor Champion" (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed a six-month program that provides education and advocacy training to waitlist candidates and their LDCs. The instrumental support provided by the LDC bridges a critical link between education and action. In pilot studies, candidates with an LDC were more likely to undergo Live Donor Kidney Transplant (LDKT) than matched controls. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm, including support from United Network for Organ Sharing.
Live Donor Champions (LDCs) as Instrumental Support for Transplant Candidates. Approaching potential donors is a daunting and overwhelming experience for Kidney Transplant (KT) candidates. Current educational programs address the medical aspects of dialysis, KT, and donation, but neglect the health communication skills to discuss transplantation and to spread awareness through their various social networks. While transplant candidates are hesitant to engage others in conversations about End Stage Renal Disease (ESRD) and live donation, friends, family members, or community members are eager to spread awareness and provide advocacy for the patient. In pilot studies, this intervention improved knowledge regarding LDKT and provided instrumental support to the transplant candidates. Understanding what factors are associated with the successful implementation of this program will enable its eventual dissemination at transplant centers nationwide ultimately improving nationwide education and awareness of LDKT. In order to successfully do so, a scientifically rigorous implementation study is necessary.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live Donor Champion | Other | Behavioral: Live Donor Champion ProgramThe Live Donor Champion program is the sole educational intervention for this trial. LDC consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy 6) Program Recap. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant candidates aged≥18 added to the waitlist in the last year with no potential live donors are eligible.
- If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the trial and may still benefit from identification of new donors or increased comfort accepting donation from others.
- Participants at University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.
Key exclusion criteria (12 listed)
- Candidates with live donors currently under evaluation for donation will be excluded.
- Those with a previous kidney transplant will be excluded
- Live Donor Champions Inclusion Criteria
- aged≥18
- English-speaking
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 |
|---|---|---|
| Live Donor Champion ProgramAlso: LDC ProgramEven with adequate education of live donation, many KT 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 substantial instrumental support. An 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 a 6-month program that provides education and advocacy training to waitlist candidates and their LDCs. The instrumental 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 | Live Donor Champion |
Primary outcome
Acceptability - Implementation Outcome
Time frame: within 2 years of enrollment
Acceptability is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Acceptability will be measured qualitatively using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Adoption - Implementation Outcome
Time frame: within 2 years of enrollment
Adoption is defined as the intention or action to employ an innovation or practice. Adoption will be measured qualitatively using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Appropriateness - Implementation Outcome
Time frame: within 2 years of enrollment
Appropriateness is a qualitative measure of the perceived fit, relevance, or compatibility of the innovation for a given setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue. We will measure program appropriateness using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Cost - Implementation Outcome
Time frame: within 2 years of enrollment
Cost (incremental or implementation cost) is the cost impact of an implementation effort. Implementation cost will be assessed by estimations made during observational sessions of the intervention.
Feasibility - Implementation Outcome
Time frame: within 2 years of enrollment
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 using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Fidelity - Implementation Outcome
Time frame: within 2 years of enrollment
Fidelity is defined as the degree to which an intervention was implemented as prescribed in the original protocol or as it was intended by the developers. Fidelity will be qualitatively assessed using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
Penetration - Implementation Outcome
Time frame: within 2 years of enrollment
Penetration is the integration of a practice within a setting or subsystem. Penetration of the LDC program within our two sites will be measured by calculating the number of eligible persons who use a service, divided by the total number of eligible.
Sustainability - Implementation Outcome
Time frame: within 2 years of enrollment
Sustainability is defined as the extent to which a newly implemented treatment is maintained or institutionalized within a service setting's ongoing, stable operations. Sustainability will be qualitatively assessed using an adapted Consolidated Framework for Implementation Research (CFIR) instrument. This instrument will be used during interviews with key stakeholders.
4 secondary outcomes
Live donor kidney transplantation
Time frame: within 1 year of enrollment
Live Donor Inquiries
Time frame: within 1 year of enrollment
Knowledge of live donation and kidney transplantation
Time frame: within 6 months of enrollment
Comfort initiating conversations
Time frame: within 6 months 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 King, MD PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Donor Champion Program in people with End-stage Renal Disease, run by Johns Hopkins University at 2 sites 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 3 inclusion and 12 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 2 sites 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?
Acceptability - Implementation Outcome (time frame: within 2 years of enrollment). The study lists 8 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.