Patient-Guided Education for Kidney Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Ckd stage 1, 2, others

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

Compensation: Varies

Number of Visits: Unknown

977 Participants Needed

Trial Summary

What is the purpose of this trial?

Today, there are 25 million Americans with chronic kidney disease (CKD) and 660,000 patients in full kidney failure, the final CKD stage, known as end stage renal disease (ESRD). Over half of ESRD patients are Black, Hispanic, or Asian. ESRD patients must either receive regular dialysis treatments, by which waste is filtered from the blood by a machine, or a kidney transplant from a deceased or living donor. Five-year survival on dialysis is only 40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living donor kidney transplant (LDKT). Despite the known health benefits of DDKT and LDKT, 70% of ESRD patients remain on dialysis, especially ethnic/racial minorities. An American Society of Transplantation (AST) Consensus Conference recently recommended that patients in all CKD stages should have the opportunity to learn about and decide which treatment option is right for them, particularly about LDKT. However, early education about LDKT and DDKT is inconsistent and often poor, with early stage CKD patients and ethnic/racial minorities even less likely to receive it. Through previous HRSA grants, Dr. Waterman designed the Explore Transplant@Home (ET@Home) video-guided education program, and found that it significantly increased LDKT knowledge and informed decision-making for Black and White dialysis patients in Missouri when delivered by mail and supported through bimonthly postcards and texting. Now based at the University of California, Los Angeles (UCLA), she has partnered with Kaiser Permanente Southern California (KPSC), an integrated learning healthcare system providing insurance coverage and comprehensive care to 65,000 patients in CKD Stages 3, 4 and 5 (ESRD) (24% Hispanic, 52% White, 15% Black, and 9% Asian; 10% Spanish-speaking).

Eligibility Criteria

This trial is for adults over 18 with chronic kidney disease stages 3, 4, or end stage (5), who identify as African American, White, Hispanic, or Asian. They must be able to speak and read English or Spanish.

Inclusion Criteria

My kidney disease is at stage 3, 4, or 5.

You must identify yourself as African American, White, Hispanic, or Asian.

I can speak and read in English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Research

Conduct extensive qualitative and quantitative formative research to understand and compare the knowledge, informed decision-making, and educational needs of diverse patient groups prior to intervention

4-8 weeks

Intervention

Randomized controlled trial where patients receive either standard-of-care education or the ET@Home program over a 6-month period

6 months

Bimonthly postcards and weekly texting for ET@Home group

Follow-up

Participants are monitored for knowledge and decision-making improvements regarding kidney transplant options

4 weeks

Treatment Details

Interventions

• Patient-Guided

Trial Overview The trial tests the 'Explore Transplant@Home' program designed to educate patients about kidney transplant options. It uses videos sent by mail along with postcards and texts for support.

Participant Groups

Group I: Patient-Guided Experimental Treatment 1 Intervention

Patients in the ET@Home study condition will receive four modules of video and print transplant education over a 6-month period. After each module is mailed, 3 postcards are mailed weekly that recap important transplant educational content covered within the videos. Patients will have the opportunity to participate in a texting component of ET@Home that also sends small pieces of educational content and learning reminders by phone each week.

Group II: Standard of Care (Control) Active Control 1 Intervention

For patients who are randomized to the control condition and who are or become potentially eligible for transplant during their enrollment in the study, they will not receive any additional interventions during the study period. Patients in this condition will only receive the education that is administered by the KPSC Kidney Transplant Program and will not receive any educational materials designed for the intervention group of this study.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+