Educational Intervention for Kidney Disease

(KidneyTIME Trial)

Overseen By Brad Bermudez

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Previous intervention exposure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to educate people about kidney transplants from living donors. It compares a digital self-learning program called KidneyTIME, which features short animated videos, to the usual educational methods provided by transplant centers. The goal is to determine which method better helps patients understand kidney transplants and feel more prepared to discuss living-donor options. Individuals considering a kidney transplant, who can speak English and have internet access, might be a good fit. As an unphased trial, participants contribute to innovative educational approaches that may enhance future transplant experiences.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the KidneyTIME intervention is safe?

Research has shown that the KidneyTIME program educates people about kidney transplants and living donations. Animated videos simplify these complex topics, making them easier to understand. Watching these educational videos is completely safe and carries no risks.

KidneyTIME provides useful information rather than medical procedures, so participants should not experience any negative effects from the program itself. While kidney donation is generally safe for donors who undergo careful screening, it can pose long-term health risks such as high blood pressure or reduced kidney function. However, these risks do not apply to those who only watch the educational content of KidneyTIME. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KidneyTIME intervention because it transforms how information about kidney transplants and donations is delivered. Unlike traditional education methods, which often involve static materials and in-person sessions, KidneyTIME uses a series of 26 animated videos to fill knowledge gaps in an engaging and accessible way. This approach not only caters to different learning styles but also allows participants to access the content anytime, anywhere, through digital platforms. By making complex medical information easier to understand and share, KidneyTIME aims to empower potential kidney donors and recipients, potentially increasing participation in living donor kidney transplants.

What evidence suggests that this trial's educational interventions could be effective for kidney transplant patients?

Research has shown that the KidneyTIME program, available to participants in this trial, uses animated videos to educate people about kidney transplants and living donations. These videos are designed for easy understanding and are well-received by those needing a kidney transplant. Early results suggest that the program enhances understanding of the transplant process and addresses common concerns. By making information more accessible, KidneyTIME aims to prepare and engage individuals in living-donor kidney transplants. This approach could improve transplant outcomes and assist patients in making informed decisions about living donation. ^{2 6 7 8 9}

Who Is on the Research Team?

Liise Kayler, MD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English, have internet access, and are referred to the transplant center for a kidney transplant. It's not open to those who've already seen parts of the intervention.

Inclusion Criteria

Speaks English

I am referred for a kidney transplant.

Has access to the internet

Exclusion Criteria

I have been treated with a component of the study intervention before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive the KidneyTIME intervention or usual care video, followed by surveys and ongoing video access

12 months

Monthly virtual prompts

Follow-up

Participants are monitored for living donor inquiries and other outcomes

12 months

Surveys at 1, 6, and 12 months

Exit Interview

Intervention participants are invited to an exit interview; controls offered access to intervention website

What Are the Treatments Tested in This Trial?

Interventions

• Kidney donation and transplant information made easy

Trial Overview The study compares KidneyTIME—a video-based education and mobile communication tool about living-donor kidney transplants—with usual care. Participants are randomly placed into two groups to see if KidneyTIME improves knowledge and readiness over a year.

How Is the Trial Designed?

Group I: KidneyTIME Experimental Treatment 1 Intervention

KidneyTIME is a self-directed digital intervention. It contains 26 animated videos, each 1-3 minutes in length, 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. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 26 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website could be accessed using this link from any electronic device throughout the study. Prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months.

Group II: Usual Care Active Control 1 Intervention

Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32072670/

Development of the living donation and kidney ... Development of the living donation and kidney transplantation information made easy (KidneyTIME) educational animations. Clin Transplant. 2020 Apr;34(4): ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/ctr.13830

Development of the living donation and kidney ... This paper describes the process of developing animation-based LKD education designed to be suitable for and acceptable to kidney transplant candidates and ...

3. researchgate.net researchgate.net/publication/339356530_Development_of_the_living_donation_and_kidney_transplantation_information_made_easy_KidneyTIME_educational_animations

(PDF) Development of the living donation and kidney ... Development of the living donation and kidney transplantation information made easy (KidneyTIME) educational animations ; Beth Dolph ; Rachel ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4559504/

Living Donor Kidney Transplantation The study concluded that, compared with matched nondonors, prior living donors had a higher rate of DDKT, a shorter wait time, and lower post-transplant ...

5. kidney-international.org kidney-international.org/article/S0085-2538(20)30906-6/fulltext

Measuring quality in living donation and ... One-year patient and allograft survival have improved dramatically since the first successful kidney transplant in 1954.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05154773

Increasing Live Donor Kidney Transplantation Through ... Safety continues to be evaluated, and short-term adverse events ... Behavioral : Kidney donation and transplant information made easy. Same as arm description.

7. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.14024/full

Evaluating Risk in Kidney Living Donors Kidney donation is a safe procedure for carefully screened donors. The growing shortage of organs and improved survival rates among ...

8. kidney.org kidney.org/kidney-topics/what-to-expect-after-donation

What to Expect After Donation While donating a kidney is generally very safe, it's important to know about the possible long-term health issues that you could be at risk for ...

9. unos.org unos.org/transplant/living-donation/

Living Donation Facts and Resources from UNOS Possible long-term risks of kidney donation may include high blood pressure (hypertension); reduced kidney function, which may be measured by large amounts of ...