Digital-Analog Intervention for Chronic Kidney Disease

(KIDNEYTIME+ Trial)

Overseen By Liise Kayler, MD, MS, FACS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Previously exposed, Multilisted, Multiorgan

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people access living-donor kidney transplants. It compares a digital tool, KidneyTIME+, used with or without a human guide, to determine which is more effective at helping patients learn about and reach out for donor kidneys. Those referred to a transplant center and considering kidney transplants might be a good fit for this trial. Participants will use the tool to explore their options and improve their chances of finding a kidney donor. As an unphased trial, this study provides participants the opportunity to explore innovative methods for increasing their chances of finding a kidney donor.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that KidneyTIME+, a digital and in-person program, is designed to be safe. This program uses animated videos to educate patients and potential donors about living-donor kidney transplants. By focusing on education and outreach through mobile technology, it avoids the risks associated with drugs or surgeries.

No specific reports of negative effects have emerged from using KidneyTIME+. This program is part of the KidneyTIME-2 initiative, which helps patients learn about donor options. In this trial, some participants receive additional support from individuals, but the primary focus remains on education.

The study is labeled as "Not Applicable" for a phase, indicating it likely does not test a new drug or risky procedure, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KidneyTIME+ intervention because it leverages digital technology to enhance education and outreach around living donor kidney transplantation. Unlike traditional methods that rely heavily on routine clinical support, KidneyTIME+ offers a mobile-based platform, KidneyTime-2, which empowers patients and their networks to independently learn and engage potential donors. A unique feature of this intervention is the option for human guide support, available over six months, which helps users navigate the platform and maximize its benefits. This combination of digital and personalized support aims to increase the accessibility and effectiveness of living donor kidney transplantation education, potentially leading to better patient outcomes.

What evidence suggests that this trial's treatments could be effective for increasing living-donor kidney transplant access?

Research has shown that tools like KidneyTIME+ can increase the number of living-donor kidney transplants. In this trial, participants will join one of two groups: one will use KidneyTIME-2 without human support, while the other will use it with human support. Studies have found that patients using mobile education tools, such as KidneyTIME+, often learn more and actively seek donors. People generally view these educational tools positively, as they help clarify the living kidney donation process. Additionally, those who receive kidney transplants tend to live longer than those who remain on dialysis, highlighting the importance of increasing transplant access. Overall, KidneyTIME+ aims to educate and support patients, potentially leading to better health outcomes. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with chronic kidney issues or those seeking a kidney transplant. It's open to individuals being evaluated at a specific transplant center. Participants must consent and undergo an initial assessment, but details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Speaks English

I am referred for a kidney transplant.

I am 18 years old or older.

Exclusion Criteria

Listed for a kidney transplant at another center (multilisted)

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

I am seeking a transplant for more than one organ.

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 with or without human guide support, including video education and donor outreach materials

6 months

Weekly emails, periodic in-person visits

Follow-up

Participants are monitored for donor inquiries and outreach behaviors, and complete surveys to assess intervention impact

6 months

Surveys at 6 months post-evaluation

Long-term Follow-up

Assessment of time to waiting-list placement and additional follow-up measures

12 months

What Are the Treatments Tested in This Trial?

Interventions

• KidneyTIME+

Trial Overview The study compares two approaches to increase access to living-donor kidney transplants: one using only digital education (KidneyTIME+) and the other combining digital education with personal guidance from a human guide. Patients are randomly assigned to either group.

How Is the Trial Designed?

Group I: KidneyTime-2 with human support Experimental Treatment 1 Intervention

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.

Group II: KidneyTime-2 without human support Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Citations

1. withpower.com withpower.com/trial/phase-kidney-failure-chronic-2026-b23d7

Digital-Analog Intervention for Chronic Kidney Disease ... Trial Overview The study compares two approaches to increase access to living-donor kidney transplants: one using only digital education (KidneyTIME+) and the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9981888/

Comparison of outcomes of chronic kidney disease based ... Post-hoc study of a clinical trial showed that those patients with PKD had a higher risk of kidney failure and a lower risk of death than those with CKD with ...

3. researchgate.net researchgate.net/publication/363596198_Patient_perceptions_by_race_of_educational_animations_about_living_kidney_donation_made_for_a_diverse_population

Patient perceptions by race of educational animations ... Methods We conducted a secondary analysis of 88 transcripts derived from interviews and focus groups conducted with diverse target users (62 kidney failure ...

4. mdpi.com mdpi.com/2077-0383/14/19/7017

Selection Patterns and Outcomes of Kidney ... The 78% 5-year survival in kidney transplant recipients demonstrates outcomes achievable with careful selection, while the 21% 5-year survival in dialysis ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10035227/

Predicting outcomes in chronic kidney disease: needs and ... Guidelines recommend that nephrologists use clinical prediction models (CPMs) to help identify patients at increased risk of CKD progression and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07072767

NCT07072767 | Hybrid Dissemination Study of A Digital ... KidneyTIME+ is a digital-analog intervention with human support. It is based on animated video education targeted to patients, donors, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10895982/

Diagnostic Validity of Chronic Kidney Disease in Health ... Our results indicate that the detection of older CKD patients may perform better and may yield a higher validity in more recent German claims ...

8. kidney-international.org kidney-international.org/article/S0085-2538(25)00334-5/fulltext

Preventing chronic kidney disease and maintaining ... The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease.

9. mdpi.com mdpi.com/2673-3943/5/3/14

The Impact of Early-to-Moderate Stage Chronic Kidney ... Multivariate analysis revealed that CKD patients had a 31% higher risk of all-cause mortality (OR = 1.31, 95% CI: 1.01–1.70; p = 0.04) and a ...