Digital Tools for Kidney Disease

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Methodist Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Approximately 15% of the U.S. population has chronic kidney disease, and \~700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the standard of care continues to be ongoing dialysis, which has poor clinical outcomes in comparison to LDKT and DDKT. Best practices to transform kidney care recommended by the Centers for Medicare and Medicaid Services (CMS), the American Society of Nephrology (ASN) and the 2019 Executive Order Advancing American Kidney Health Initiative include earlier detection of patients whose kidneys are deteriorating rapidly, introducing transplant as a potential treatment option earlier, optimally before their kidneys fail, improved dissemination of health literate transplant education tools, often through digital technology or mHealth, and increasing LDKT rates by helping patients locate living donors or motivating others to donate. Barriers at the patient-, support network-, clinician- and system-levels of the Socio-Ecological Model persist, including poor identification of high-risk patients, insufficient clinician time to discuss transplant, poor transplant knowledge, reluctance or insufficient support to ask living donors to donate, and disengaged friends and relatives, some of whom who might become living donors.

While extensive policy and intervention efforts are underway, none have achieved significant increases in pursuit and receipt of transplant, especially LDKT rates. In 2017, Kaiser Permanente Southern California (KPSC), an integrated care system serving 24,000 CKD patients, partnered with the Transplant Research and Education Center (TREC) at Houston Methodist Research Institute (HMRI) and J.C. Walter Jr. Transplant Center Houston Methodist Hospital (HMH) to launch a multi-year plan for transforming CKD and ESKD care.

Investigators now propose to conduct a pragmatic stepped wedge cluster randomized trial of a novel multilevel intervention to improve CKD and ESKD care, improve transplant rates and reduce disparities. One innovative component of the multilevel intervention is a state-of-the-art technology-supported mHealth application, developed in partnership with patients, to engage patients, family members, and potential living donors to improve their CKD knowledge, view transplant success stories, and seek kidney-related support to pursue transplant, including learning how to find living donors. Investigators also seek to identify moderators at various socio-ecological levels, especially factors influencing variations in effectiveness across different settings and among underserved patient subgroups known to have reduced access to transplant and build implementation tools to increase access to and pursuit of transplant within large integrated health systems including comparable systems (commercial, academic, safety net) across the U.S.

Are You a Good Fit for This Trial?

This trial is for people with chronic kidney disease or kidney failure who are considering a transplant. It aims to include patients at different stages of kidney disease, especially those who may benefit from learning about and pursuing a kidney transplant.

Inclusion Criteria

I am 18 years old or older.
I have moderate to severe chronic kidney disease or kidney failure.
English or Spanish-speaking

Exclusion Criteria

I have medical reasons that prevent me from having a transplant.

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Health Integration
  • Kidney Health Mobile Health (mHealth) Application
  • Training for Early Transplant Access and Support

Trial Overview

The study tests a new approach using digital health tools, special training for early access to transplants, and a mobile app that helps patients learn about transplants, connect with support networks, and find living donors. The goal is to improve transplant rates compared to usual care.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: System LevelExperimental Treatment1 Intervention
Group II: Provider LevelExperimental Treatment1 Intervention
Group III: Patient and Support System LevelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Kaiser Permanente

Collaborator

Trials
563
Recruited
27,400,000+