Hybrid Dissemination Study of A Digital-Analog Intervention to Increase Live Donor Kidney Transplantation
NCT ID: NCT07072767
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
430 participants
INTERVENTIONAL
2026-01-01
2029-07-01
Brief Summary
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Detailed Description
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Participants will be recruited from the Transplant program at Erie County Medical Center, a safety-net hospital in Buffalo, New York. Each week, electronic records will be accessed to identify patients and their carers who present for transplant evaluation at the transplant center for a kidney transplant, are aged 18 years and older, speak English, and are competent to provide informed consent . The investigators will exclude patients previously exposed to any component of the intervention, listed for transplantation at another center, and seeking multiorgan transplantation.
A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan. They will also provide input on assistive dissemination tools for organizations to engage individuals to use the resource.
Each potential participant will be invited to the study by a researcher who will describe the study and answer and questions, and provide a copy of the consent form describing study procedures and potential risks.
Those who sign electronic consent to participate will be asked to complete a baseline sociodemographic and pre-test survey. Upon completion, computer-generated randomization will stratify participants by self-reported race (Black versus Other), with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment once they access the human guide.
KidneyTIME+ is a digital-analog intervention with human support. It is based on animated video education targeted to patients, donors, and support persons, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. Other key components include (1) personalized donor outreach materials, (2) email reminders about study resources, and (3) practical assistance to ensure access to intervention, advise use the intervention and encourage outreach actions. All components of the intervention were developed through a user-centered design approach by involving kidney failure patients and social network members, to improve usability and increase the likelihood of uptake.
In both intervention and control arms, the investigators chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. The video content sets the stage for the intervention and introduces the viewer to an overview of LDKT, including addressing common misconceptions about live kidney donation, donor eligibility, donor evaluation, kidney paired donation, donation costs, and donor recovery. After completing the proscribed videos everyone then receives weekly emails with links to the full video curriculum centralized on a website and other local resources. Email messages introduce study videos and features and local resources that may interest users, provide access links, and encourage video viewing and sharing. Messages will be personalized with the participants name and provide researchers contact information. The videos on the website are activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website also contains templates and examples for other donor outreach materials and practical engagement materials to promote awareness of the website. The website is open access from any electronic device. Finally, at clinic appointments participants will receive practical assistance to use intervention materials.
In the intervention arm, donor outreach will be supported by telephonic human guides who will provide tailored implementation support in 7 areas that include ensuring access, advising use, recommending features, encouraging donor outreach, and referrals to clinical services, support groups, community resources. Human guides will interact with participants over a 6-month period.
Control participants will not receive human guide support.
All participants routinely receive educational materials from non-study sources through usual Transplant Center protocols including written materials and clinical provider communications. Providers may recommend the study website or individuals may find it on their own.
After completing the proscribed video education, all participants will be invited to fill out serial surveys at 6 months post-evaluation. Participants will receive up to 6 reminders (5 automatic and 1 personalized) to complete surveys. At study conclusion, participants may be invited to an exit interview.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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KidneyTime-2 with human support
KidneyTIME-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Human guide support offered over a 6 month period to encourage use of the intervention and donor outreach.
Digital education outreach intervention for kidney transplant access and human guide
Receives (1) donor search materials, (2) electronic resource access messages, (3) practical assistance to use the intervention and empower taking the outreach action and (4) telephonic human guide
KidneyTime-2 without human support
KidneyTime-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Routine clinical support from non-study sources through usual Transplant Center protocols including clinic provider communications.
Digital education outreach intervention for kidney transplant access only (unguided)
Receives (1) donor search materials, (2) electronic resource access messages, and (3) practical assistance to use the intervention and empower taking the outreach action.
Interventions
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Digital education outreach intervention for kidney transplant access and human guide
Receives (1) donor search materials, (2) electronic resource access messages, (3) practical assistance to use the intervention and empower taking the outreach action and (4) telephonic human guide
Digital education outreach intervention for kidney transplant access only (unguided)
Receives (1) donor search materials, (2) electronic resource access messages, and (3) practical assistance to use the intervention and empower taking the outreach action.
Eligibility Criteria
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Inclusion Criteria
* aged 18 years and older
* speaks English
Exclusion Criteria
* Listed for a kidney transplant at another center (multilisted)
* Seeking multiorgan transplantation
18 Years
ALL
No
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Liise Kayler
Principal Investigator
Locations
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Erie County Medical Center, 462 Grider Street
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Liise Kayler
Role: backup
Other Identifiers
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STUDY00014971
Identifier Type: -
Identifier Source: org_study_id
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