Hybrid Dissemination Study of A Digital-Analog Intervention to Increase Live Donor Kidney Transplantation

Not Applicable

Not yet recruiting

• Conditions: End-Stage Renal Disease; Chronic Kidney Diseases; Kidney Transplant; Living Kidney Donor

• Registration Number: NCT07072767
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

The study is a 2-arm randomized controlled trial among patients referred for kidney transplant evaluation at a single transplant center to compare the effects of a digital-analog intervention to increase living-donor kidney transplant access (KidneyTIME+) with or without human guide . Following consent and baseline assessment, participants are randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide.

Detailed Description

Over a 3-year period the investigators will conduct a pilot 2-arm parallel randomized trial among patients referred for kidney transplantation at a single transplant center to compare the effects of KidneyTIME+ with or without ongoing human support for KTX access over 6 months of intervention use and follow-up.

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2026-01-01
• Primary Completion: 2029-01-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• referred to the transplant center for a kidney transplant
• aged 18 years and older
• speaks English

Exclusion Criteria

• Previously exposed to any component of the intervention
• Listed for a kidney transplant at another center (multilisted)
• Seeking multiorgan transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Living donor inquiry	Baseline, post baseline 6 months	Count of living donor inquires to the transplant center on behalf of the study participants within 6 months from enrollment. Each inquiry (telephone call, email, letter) is counted and added to a discrete field for all patients in the electronic medical record.

Secondary Outcome Measures

Name	Time	Method
LDKT Perceived understanding	Baseline, post baseline 6 months	Developed specifically for this study as a measure of perceived understanding about LDKT as delivered in the intervention condition. In this 4 item 4-point Likert questionnaire, total scores range from 4-16 with higher scores indicating greater LDKT-related understanding. The scale captures different dimensions of understanding including kidney transplant navigation, awareness of services, and donor outreach.
LDKT Conversational self-efficacy	Baseline, post baseline 6 months	A 2-item survey testing confidence to communicate about LDKT with others. Items are rated on a scale of 1 to 4, total scores range from 2-8. Higher scores indicate greater confidence to communicate about LDKT with others.
LDKT Beliefs scale	Baseline, post baseline 6 months	Developed specifically for this study as a measure of patients' beliefs about LDKT. Questions were drawn from existing measures in the literature. We created a 2-item scale. One item captured the degree to which a person believes that LDKT is an advantage. The other item assessed the degree to which a person believes their social network is healthy enough to donate a kidney. Items are rated on a scale of 1 to 4. Total scores range from 2-8 with higher scores indicate greater concerns about live kidney donation.
Donor outreach behaviors	Baseline, post baseline 6 months	A measure of ongoing outreach toward living donor kidney transplantation. To assess LDKT action behaviors patients will be asked whether they had done any of 14 related behaviors adapted from existing measures in the literature. Patients who indicated they had done the action will be counted and scores will range from 0 to 14. Higher scores indicate more outreach.

Trial Locations

Locations (1)

Erie County Medical Center, 462 Grider Street; 🇺🇸 Buffalo, New York, United States