HealthyNCT07206069
Telemedicine to Support Living Kidney Donor Candidates
A study testing Telemedicine Shared Decision-Making in people with Healthy and Living Kidney Donation, run by University of California, Irvine at 1 site in United States.
Trial summary
The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Living Kidney Donation
- What is being tested?
- Telemedicine Shared Decision-Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Reside in the State of California
- Registered living kidney donor candidate at UC Irvine Medical Center
Who cannot join
- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Irvine Medical Center
Orange, California, 92868
Steven Vasquez, 714-456-7431, stevenv4@hs.uci.edu
Stefaney Mendoza-Flores, 949-447-9439, stefanem@hs.uci.edu
About this study
Official title: Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates
The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are:
- Is telemedicine a practical way to facilitate donor education and evaluation and counseling?
- Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process?
Read more
Researchers will compare standard care with a telemedicine care coordination approach.
Participants will:
- Receive either standard care or telemedicine video visits to support shared decision making.
Read the detailed description
Living kidney donation provides a vital treatment option for patients with kidney failure, but many willing individuals face challenges in completing the donor evaluation and committing to donation. Donor education and counseling are essential for informed decision-making, yet these steps are often limited to in-person visits at transplant centers. This can create logistical challenges, delays, and variations in access to the living donor evaluation process. Telemedicine offers an opportunity to deliver a shared decision making approach to donor education and evaluation and counseling remotely, but its feasibility, acceptability, and impact have not been well studied.
This pilot feasibility clinical trial is designed to test whether a telemedicine care coordination can support donor decision-making and engagement during the evaluation process for living kidney donation.
Participants will be randomly assigned to one of two groups:
- Standard Care Group (Control): A recorded video education session and an in-person donor evaluation and counseling with a nephrologist.
- Telemedicine Group (Intervention): Two live telemedicine video sessions-one for education with a transplant provider and one for donor evaluation and counseling with a nephrologist.
The findings from this feasibility trial will provide important information about the practicality and acceptability of telemedicine shared decision-making for living kidney donor candidates. Generated preliminary data will inform larger trials and ultimately guide transplant practice and policy to improve decision-making, efficiency, and access to living kidney donation.
- Conditions
- Healthy, Living Kidney Donation
- Being tested
- Standard Care (in control arm), Telemedicine Shared Decision-Making
- Keywords
- Kidney donation, Telemedicine, Education, Counseling, Decision Making, Shared, Feasibility studies, Health Services Research, Care Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care (in control arm)Behavioural
Also called Control
This Standard Care involves a recorded video education and in-person visit.
Telemedicine Shared Decision-MakingBehavioural
Also called Experimental
This intervention involves two live telemedicine video visits.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group (Control) | Active comparator | Participants in the standard care group will receive a recorded video education session and one in-person donor evaluation and counseling session with a nephrologist. Receives: Behavioral: Standard Care (in control arm) |
| Telemedicine Group (Intervention) | Experimental | Participants in the telemedicine group will receive two live telemedicine video sessions: one education session with a transplant provider and one donor evaluation and counseling session with a nephrologist. Receives: Behavioral: Telemedicine Shared Decision-Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.
Measured: 90 days
Retention Rate
Proportion of enrolled participants who remain in the study through the 90-day follow-up period, calculated as the number completing final follow-up divided by the number enrolled.
Measured: 90 days
Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)
Decision conflict will be measured using the Decisional Conflict Scale (DCS), a 16-item validated instrument. Each item is scored from 0 (no conflict) to 100 (very high conflict), and a total score is calculated by averaging across items. Total scores therefore range from 0 to 100, with higher scores indicating worse decision conflict and greater uncertainty.
Measured: 90 days
Secondary outcomes (2)
Completion of Donor Education and Evaluation and Counseling
Completion of donor education and evaluation and counseling.
Time to donor evaluation and counseling completion.
Measured: 90 days
Intervention Acceptability
Participant-reported acceptability of the telemedicine intervention will be measured using the acceptability of intervention measure. This outcome will be assessed only in the Telemedicine Intervention Arm.
Measured: Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start4 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawaz Al Ammary, University of California, Irvine
- Investigators
- Fawaz Al Ammary, MD PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206069
- Sponsor's protocol ID
- UC Irvine IRB#4138
- Other IDs
- K23DK129820
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data that underlie the results reported in publications will be shared. This will include baseline demographic characteristics, survey responses, and donor candidate disposition data. Data will be deposited in Dryad and accompanied by a data dictionary, study protocol, and statistical analysis plan.
Publications
Al Ammary F, Adeyemo S, Lentine KL, Muzaale AD. Evolution of Biologically Related Living Kidney Donation in the United States from 1988 to 2022. J Am Soc Nephrol. 2024 Aug 1;35(8):1104-1106. doi: 10.1681/ASN.0000000000000424. Epub 2024 May 29. No abstract available.
PubMed 38809617Al Ammary F, Yu Y, Ferzola A, Motter JD, Massie AB, Yu S, Thomas AG, Crews DC, Segev DL, Muzaale AD, Henderson ML. The first increase in live kidney donation in the United States in 15 years. Am J Transplant. 2020 Dec;20(12):3590-3598. doi: 10.1111/ajt.16136. Epub 2020 Jul 17.
PubMed 32524764Achkar KA, Abdelnour LM, Abu Jawdeh BG, Tantisattamoa E, Al Ammary F. Evaluation and Long-Term Follow-Up of Living Kidney Donors. Adv Kidney Dis Health. 2024 Sep;31(5):400-407. doi: 10.1053/j.akdh.2024.04.003.
PubMed 39232610Al Ammary F, Bowring MG, Massie AB, Yu S, Waldram MM, Garonzik-Wang J, Thomas AG, Holscher CM, Qadi MA, Henderson ML, Wiseman AC, Gralla J, Brennan DC, Segev DL, Muzaale AD. The changing landscape of live kidney donation in the United States from 2005 to 2017. Am J Transplant. 2019 Sep;19(9):2614-2621. doi: 10.1111/ajt.15368. Epub 2019 May 3.
PubMed 30903733Al Ammary F, Motter JD, Sung HC, Lentine KL, Sharfuddin A, Kumar V, Yadav A, Doshi MD, Virmani S, Concepcion BP, Grace T, Sidoti CN, Yahya Jan M, Muzaale AD, Wolf J. Telemedicine services for living kidney donation: A US survey of multidisciplinary providers. Am J Transplant. 2022 Aug;22(8):2041-2051. doi: 10.1111/ajt.17093. Epub 2022 May 31.
PubMed 35575439Al Ammary F, Muzaale AD, Tantisattamoa E, Hanna RM, Reddy UG, Bunnapradist S, Kalantar-Zadeh K. Changing landscape of living kidney donation and the role of telemedicine. Curr Opin Nephrol Hypertens. 2023 Jan 1;32(1):81-88. doi: 10.1097/MNH.0000000000000848. Epub 2022 Oct 21.
PubMed 36444666Kim E, Sung HC, Kaplow K, Bendersky V, Sidoti C, Muzaale AD, Akhtar J, Levan M, Esayed S, Khan A, Mejia C, Al Ammary F. Donor Perceptions and Preferences of Telemedicine and In-Person Visits for Living Kidney Donor Evaluation. Kidney Int Rep. 2024 May 15;9(8):2453-2461. doi: 10.1016/j.ekir.2024.05.009. eCollection 2024 Aug.
PubMed 39156145
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates
- ClinicalTrials.gov ID
- NCT07206069
- Acronym / sponsor ID
- UC Irvine IRB#4138
- Conditions
- Healthy, Living Kidney Donation
- Keywords
- Kidney donation, Telemedicine, Education, Counseling, Decision Making, Shared, Feasibility studies, Health Services Research, Care Delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (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 goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are:
- Is telemedicine a practical way to facilitate donor education and evaluation and counseling?
- Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process?
Researchers will compare standard care with a telemedicine care coordination approach.
Participants will:
- Receive either standard care or telemedicine video visits to support shared decision making.
Detailed description
Living kidney donation provides a vital treatment option for patients with kidney failure, but many willing individuals face challenges in completing the donor evaluation and committing to donation. Donor education and counseling are essential for informed decision-making, yet these steps are often limited to in-person visits at transplant centers. This can create logistical challenges, delays, and variations in access to the living donor evaluation process. Telemedicine offers an opportunity to deliver a shared decision making approach to donor education and evaluation and counseling remotely, but its feasibility, acceptability, and impact have not been well studied.
This pilot feasibility clinical trial is designed to test whether a telemedicine care coordination can support donor decision-making and engagement during the evaluation process for living kidney donation.
Participants will be randomly assigned to one of two groups:
- Standard Care Group (Control): A recorded video education session and an in-person donor evaluation and counseling with a nephrologist.
- Telemedicine Group (Intervention): Two live telemedicine video sessions-one for education with a transplant provider and one for donor evaluation and counseling with a nephrologist.
The findings from this feasibility trial will provide important information about the practicality and acceptability of telemedicine shared decision-making for living kidney donor candidates. Generated preliminary data will inform larger trials and ultimately guide transplant practice and policy to improve decision-making, efficiency, and access to living kidney donation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group (Control) | Active comparator | Behavioral: Standard Care (in control arm)Participants in the standard care group will receive a recorded video education session and one in-person donor evaluation and counseling session with a nephrologist. |
| Telemedicine Group (Intervention) | Experimental | Behavioral: Telemedicine Shared Decision-MakingParticipants in the telemedicine group will receive two live telemedicine video sessions: one education session with a transplant provider and one donor evaluation and counseling session with a nephrologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Reside in the State of California
- Registered living kidney donor candidate at UC Irvine Medical Center
Key exclusion criteria (1 listed)
- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)
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 |
|---|---|---|
| Standard Care (in control arm)Also: ControlThis Standard Care involves a recorded video education and in-person visit. | Behavioural | Standard Care Group (Control) |
| Telemedicine Shared Decision-MakingAlso: ExperimentalThis intervention involves two live telemedicine video visits. | Behavioural | Telemedicine Group (Intervention) |
Primary outcome
Recruitment Rate
Time frame: 90 days
Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.
Retention Rate
Time frame: 90 days
Proportion of enrolled participants who remain in the study through the 90-day follow-up period, calculated as the number completing final follow-up divided by the number enrolled.
Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)
Time frame: 90 days
Decision conflict will be measured using the Decisional Conflict Scale (DCS), a 16-item validated instrument. Each item is scored from 0 (no conflict) to 100 (very high conflict), and a total score is calculated by averaging across items. Total scores therefore range from 0 to 100, with higher scores indicating worse decision conflict and greater uncertainty.
2 secondary outcomes
Completion of Donor Education and Evaluation and Counseling
Time frame: 90 days
Intervention Acceptability
Time frame: Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 38809617Al Ammary F, Adeyemo S, Lentine KL, Muzaale AD. Evolution of Biologically Related Living Kidney Donation in the United States from 1988 to 2022. J Am Soc Nephrol. 2024 Aug 1;35(8):1104-1106. doi: 10.1681/ASN.0000000000000424. Epub 2024 May 29. No abstract available.
- Background: PubMed 32524764Al Ammary F, Yu Y, Ferzola A, Motter JD, Massie AB, Yu S, Thomas AG, Crews DC, Segev DL, Muzaale AD, Henderson ML. The first increase in live kidney donation in the United States in 15 years. Am J Transplant. 2020 Dec;20(12):3590-3598. doi: 10.1111/ajt.16136. Epub 2020 Jul 17.
- Background: PubMed 39232610Achkar KA, Abdelnour LM, Abu Jawdeh BG, Tantisattamoa E, Al Ammary F. Evaluation and Long-Term Follow-Up of Living Kidney Donors. Adv Kidney Dis Health. 2024 Sep;31(5):400-407. doi: 10.1053/j.akdh.2024.04.003.
- Background: PubMed 30903733Al Ammary F, Bowring MG, Massie AB, Yu S, Waldram MM, Garonzik-Wang J, Thomas AG, Holscher CM, Qadi MA, Henderson ML, Wiseman AC, Gralla J, Brennan DC, Segev DL, Muzaale AD. The changing landscape of live kidney donation in the United States from 2005 to 2017. Am J Transplant. 2019 Sep;19(9):2614-2621. doi: 10.1111/ajt.15368. Epub 2019 May 3.
- Background: PubMed 35575439Al Ammary F, Motter JD, Sung HC, Lentine KL, Sharfuddin A, Kumar V, Yadav A, Doshi MD, Virmani S, Concepcion BP, Grace T, Sidoti CN, Yahya Jan M, Muzaale AD, Wolf J. Telemedicine services for living kidney donation: A US survey of multidisciplinary providers. Am J Transplant. 2022 Aug;22(8):2041-2051. doi: 10.1111/ajt.17093. Epub 2022 May 31.
- Background: PubMed 36444666Al Ammary F, Muzaale AD, Tantisattamoa E, Hanna RM, Reddy UG, Bunnapradist S, Kalantar-Zadeh K. Changing landscape of living kidney donation and the role of telemedicine. Curr Opin Nephrol Hypertens. 2023 Jan 1;32(1):81-88. doi: 10.1097/MNH.0000000000000848. Epub 2022 Oct 21.
- Background: PubMed 39156145Kim E, Sung HC, Kaplow K, Bendersky V, Sidoti C, Muzaale AD, Akhtar J, Levan M, Esayed S, Khan A, Mejia C, Al Ammary F. Donor Perceptions and Preferences of Telemedicine and In-Person Visits for Living Kidney Donor Evaluation. Kidney Int Rep. 2024 May 15;9(8):2453-2461. doi: 10.1016/j.ekir.2024.05.009. eCollection 2024 Aug.
- Individual participant dataSharing planned: Yes. De-identified participant data that underlie the results reported in publications will be shared. This will include baseline demographic characteristics, survey responses, and donor candidate disposition data. Data will be deposited in Dryad and accompanied by a data dictionary, study protocol, and statistical analysis plan.
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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.
Fawaz Al Ammary, MD PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Shared Decision-Making in people with Healthy and Living Kidney Donation, run by University of California, Irvine 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 3 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fawaz Al Ammary, MD PhD (657-223-4966, fawaz.alammary@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07206069, which also lists 7 linked publications.
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 5 May 2026.