Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT07206069
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine to Support Living Kidney Donor Candidates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': '90 days', 'description': 'Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.'}, {'measure': 'Retention Rate', 'timeFrame': '90 days', 'description': '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.'}, {'measure': 'Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)', 'timeFrame': '90 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Completion of Donor Education and Evaluation and Counseling', 'timeFrame': '90 days', 'description': 'Completion of donor education and evaluation and counseling.\n\nTime to donor evaluation and counseling completion.'}, {'measure': 'Intervention Acceptability', 'timeFrame': 'Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney donation', 'Telemedicine', 'Education', 'Counseling', 'Decision Making, Shared', 'Feasibility studies', 'Health Services Research', 'Care Delivery'], 'conditions': ['Healthy', 'Living Kidney Donation']}, 'referencesModule': {'references': [{'pmid': '38809617', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32524764', 'type': 'BACKGROUND', 'citation': 'Al 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.'}, {'pmid': '39232610', 'type': 'BACKGROUND', 'citation': 'Achkar 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.'}, {'pmid': '30903733', 'type': 'BACKGROUND', 'citation': 'Al 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.'}, {'pmid': '35575439', 'type': 'BACKGROUND', 'citation': 'Al 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.'}, {'pmid': '36444666', 'type': 'BACKGROUND', 'citation': 'Al 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.'}, {'pmid': '39156145', 'type': 'BACKGROUND', 'citation': 'Kim 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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Is telemedicine a practical way to facilitate donor education and evaluation and counseling?\n* Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process?\n\nResearchers will compare standard care with a telemedicine care coordination approach.\n\nParticipants will:\n\n\\- Receive either standard care or telemedicine video visits to support shared decision making.', 'detailedDescription': '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.\n\nThis 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.\n\nParticipants will be randomly assigned to one of two groups:\n\n* Standard Care Group (Control): A recorded video education session and an in-person donor evaluation and counseling with a nephrologist.\n* 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Reside in the State of California\n* Registered living kidney donor candidate at UC Irvine Medical Center\n\nExclusion Criteria:\n\n\\- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)'}, 'identificationModule': {'nctId': 'NCT07206069', 'briefTitle': 'Telemedicine to Support Living Kidney Donor Candidates', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates', 'orgStudyIdInfo': {'id': 'UC Irvine IRB#4138'}, 'secondaryIdInfos': [{'id': 'K23DK129820', 'link': 'https://reporter.nih.gov/quickSearch/K23DK129820', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Group (Control)', 'description': '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.', 'interventionNames': ['Behavioral: Standard Care (in control arm)']}, {'type': 'EXPERIMENTAL', 'label': 'Telemedicine Group (Intervention)', 'description': '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.', 'interventionNames': ['Behavioral: Telemedicine Shared Decision-Making']}], 'interventions': [{'name': 'Standard Care (in control arm)', 'type': 'BEHAVIORAL', 'otherNames': ['Control'], 'description': 'This Standard Care involves a recorded video education and in-person visit.', 'armGroupLabels': ['Standard Care Group (Control)']}, {'name': 'Telemedicine Shared Decision-Making', 'type': 'BEHAVIORAL', 'otherNames': ['Experimental'], 'description': 'This intervention involves two live telemedicine video visits.', 'armGroupLabels': ['Telemedicine Group (Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Vasquez', 'role': 'CONTACT', 'email': 'stevenv4@hs.uci.edu', 'phone': '714-456-7431'}, {'name': 'Stefaney Mendoza-Flores', 'role': 'CONTACT', 'email': 'stefanem@hs.uci.edu', 'phone': '949-447-9439'}], 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Fawaz Al Ammary, MD PhD', 'role': 'CONTACT', 'email': 'fawaz.alammary@uci.edu', 'phone': '657-223-4966'}, {'name': 'Simeon Adeyemo, MS', 'role': 'CONTACT', 'email': 'adeyemos@hs.uci.edu', 'phone': '714-385-4875'}], 'overallOfficials': [{'name': 'Fawaz Al Ammary, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'url': 'https://datadryad.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Shared data will be made available at the time of publication of the primary results. Data will remain available in the Dryad repository for a minimum of 5 years.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Shared data will be made available through the Dryad digital repository. Supporting materials will include a data dictionary, study protocol, and statistical analysis plan. In accordance with the NIH Data Management and Sharing Plan and UC Irvine IRB guidance, no personally identifiable information will be included. Data will be shared under a CC0 waiver, allowing other researchers to reuse the de-identified data for health, medical, or biomedical research purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Director of Mixed Methods Research.', 'investigatorFullName': 'Fawaz Al Ammary', 'investigatorAffiliation': 'University of California, Irvine'}}}}