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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help patients with severe chronic kidney disease (CKD) better understand their treatment options. It focuses on educating patients, especially those from ethnic or racial minority groups, about kidney transplants through a video-guided program called Patient-Guided Education. The researchers will compare this new education method to standard care to determine if it improves knowledge and decision-making. Good candidates include those with advanced CKD (Stage 3, 4, or 5) who can communicate in English or Spanish. As an unphased trial, this study offers a unique opportunity to enhance understanding of treatment options and make informed health decisions.

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. It seems to focus on education rather than medication changes.

What prior data suggests that this patient-guided education program is safe?

Research has shown that programs like ET@Home, led by patients themselves, are safe for individuals with chronic kidney disease (CKD). Studies have found that these educational tools help participants learn more and make informed choices without any risk. Unlike medication or surgery, this program delivers information through videos, postcards, and text messages, avoiding physical procedures.

Patient education is generally well-received and often improves health outcomes for those with CKD. No reports of negative effects have emerged from these educational programs, which aim to equip patients with knowledge about their treatment options. International guidelines support this method and recommend it for helping patients better understand and manage their condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient-Guided Education approach for kidney failure because it empowers patients with personalized, accessible learning tools. Unlike standard care, which often relies on in-person education sessions, this method uses multimedia like videos and print materials, along with weekly postcards and text messages, to reinforce transplant knowledge. This approach not only makes learning more convenient and engaging but also helps ensure that crucial information is retained over time. By transforming how education is delivered, researchers hope to improve patient readiness and outcomes in the transplant process.

What evidence suggests that this patient-guided education program is effective for kidney failure?

Research has shown that tailored education for patients with end-stage kidney disease greatly improves their understanding and decision-making. In this trial, participants in the Patient-Guided arm will receive the Explore Transplant@Home program, which has proven effective in helping Black and White dialysis patients understand and make informed choices about living donor kidney transplants. Studies have found that personalized education enables patients to manage their condition more effectively and make informed health decisions. This program educates patients about the benefits of different treatment options, which is crucial for their health. Overall, structured and consistent education empowers patients to take control of their health and explore transplant options effectively. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4822666/

Educating Patients about CKD: The Path to Self-Management ... Patient education is associated with better patient outcomes and supported by international guidelines and organizations, but a range of barriers prevent ...

2. ajkd.org ajkd.org/article/S0272-6386(24)01117-X/abstract

Patient Education for CKD and Decision Support in Primary ... Results. Seventy-four patients completed the study (37 in each clinic). There were no statistically significant differences in patient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11654321/

The effect of individualized education on learning needs ... The purpose of this study was to investigate the effect of individualized education on the learning needs of patients on hemodialysis (HD).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02268682

Explore Transplant at Home: Improving Low-Income ESRD ... Aim 2: Compared to standard-of-care dialysis center education, to conduct a GRCT to assess the effectiveness of patient-guided and case-manager-guided ET ...

5. mdpi.com mdpi.com/2673-8236/5/3/32

Advanced Chronic Kidney Disease and Patient Education This review provides a comprehensive analysis of all aspects of pre-dialysis education and best practices for advanced CKD patient education.

6. withpower.com withpower.com/trial/phase-kidney-failure-chronic-6-2018-04c68

Patient-Guided Education for Kidney Failure Waterman designed the Explore Transplant@Home (ET@Home) video-guided education program, and found that it significantly increased LDKT knowledge and informed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7290458/

A Patient Safety Educational Tool for Patients With Chronic ... We sought to develop and test the usability of a mobile tablet–based educational tool designed to promote patient awareness of relevant safety topics in CKD.

8. researchgate.net researchgate.net/publication/351092774_Patient_Education_for_Kidney_Failure_Treatment_A_Mixed-Methods_Study

Patient Education for Kidney Failure Treatment: A Mixed- ... Rationale & objective: Education programs are needed for people with advanced chronic kidney disease (CKD) to understand kidney failure ...