Educational Program for Kidney Disease

(CKD-EDU Trial)

Recruiting at 4 trial locations

Overseen By Allison Study Coordinator

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Dialysis, Hospice, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

326 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which educational program better assists older adults with advanced kidney disease in making informed treatment decisions. Researchers will compare two groups: one attending sessions with a kidney therapy educator and the other meeting with a decision-support expert. The trial will assess whether these programs can reduce hospital visits and improve end-of-life care. It suits individuals aged 75 and older with advanced kidney disease who have not yet decided on dialysis. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance decision-making support for others in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational programs rather than medication changes.

What prior data suggests that these educational programs are safe for older patients with kidney disease?

Research shows that the programs under study, Program A and Program B, are educational and support-based interventions for kidney disease. These programs are generally considered safe because they do not involve drugs or medical procedures. Instead, they provide information and support to help patients make informed treatment decisions.

Educational programs like these are usually very safe, as they empower patients without exposing them to physical risks. No known negative effects result from receiving educational support or help with decision-making.

In this trial, both programs aim to help participants with kidney disease feel more prepared about their treatment options and possibly improve their overall care. The study is labeled "Not Applicable," indicating that the programs are non-invasive and low risk, focusing on education and support rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these programs for kidney disease because they focus on education and decision-making support, which are often overlooked in standard care. Program A offers personalized kidney therapy education and support from a dedicated kidney therapy educator, aiming to empower patients with the knowledge they need to manage their condition effectively. Program B emphasizes a palliative care-based decision-support intervention, helping patients make informed choices about their kidney treatment options. These programs stand out because they aim to enhance patient engagement and informed decision-making, which could lead to improved patient outcomes and satisfaction.

What evidence suggests that this trial's programs could be effective for kidney disease?

Research has shown that education programs can help people with chronic kidney disease (CKD) make better treatment choices. These programs may also lower HbA1c levels, a measure of blood sugar, in patients with both CKD and diabetes, potentially aiding in managing some health issues. However, their impact on other outcomes, such as hospital visits or overall kidney health, remains unclear. In this trial, participants will enroll in different programs. Program A provides kidney therapy education and support with a kidney therapy educator, while Program B offers decision-making support through guidance from specialists. Although limited data exists on how well these programs reduce hospital visits or improve end-of-life care, focusing on education and support seems promising for enhancing patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Fahad Saeed, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for older adults with advanced chronic kidney disease. Participants should be interested in learning about their condition and treatment options to make better health decisions. Specific eligibility details are not provided, but typically, participants must meet certain health criteria.

Inclusion Criteria

Speaks English

I have not decided on starting dialysis.

I am 75 years old or older.

Exclusion Criteria

I have chosen either dialysis or active medical care without it.

I have seen a Palliative Care specialist or am enrolled in hospice.

I am currently receiving dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Program A or Program B to aid in kidney therapy decision-making

12 weeks

Regular meetings with educators or decision-support specialists

Follow-up

Participants are monitored for changes in decision-making, hospital visits, and end-of-life care

6 months

Periodic reviews of medical charts and electronic health records

What Are the Treatments Tested in This Trial?

Interventions

• CKD-EDU

Trial Overview The study tests if an educational program (CKD-EDU) plus meetings with a palliative care specialist can help patients make more informed kidney therapy choices compared to usual nephrology care alone. The impact on emergency visits, hospital admissions, and end-of-life care quality will also be assessed.

How Is the Trial Designed?

Group I: Program A Active Control 1 Intervention

Kidney therapy education and support with kidney therapy educator.

Group II: Program B Active Control 1 Intervention

Behavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Educational interventions for patients with chronic kidney disease (CKD) can significantly improve knowledge, self-management, and quality of life, as shown in a systematic review of 26 studies involving 5,403 participants.

Effective interventions were characterized by interactive teaching sessions, group participation, and frequent interactions with educators, leading to better clinical outcomes and patient engagement in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Interventions for Patients With CKD: A Systematic Review. Lopez-Vargas, PA., Tong, A., Howell, M., et al.[2022]

Patients with chronic kidney disease (CKD) are particularly vulnerable to adverse drug events during hospitalization, which can lead to significant harm.

The study emphasizes the need for new strategies to minimize medical errors and improve safety for CKD patients in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. Fink, JC., Chertow, GM.[2022]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Empowering and educational initiatives significantly improve the quality of life for renal patients, impacting both psychosocial and functional aspects, which is crucial for overall patient care.

Patients who receive home care and self-care training in hemodialysis show better quality of life, reduced medical service utilization, and higher satisfaction with care, highlighting the benefits of patient education and empowerment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there data to support the concept that educated, empowered patients have better outcomes? Latham, CE.[2019]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

A mobile tablet-based educational tool was developed to enhance patient awareness of safety hazards in chronic kidney disease (CKD), focusing on key topics like avoiding NSAIDs and recognizing hypoglycemia risks.

In a usability study with 12 CKD patients, the tool was found to be user-friendly, with 83% of participants completing most tasks easily and rating the experience positively, indicating its potential for improving patient education in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Patient Safety Educational Tool for Patients With Chronic Kidney Disease: Development and Usability Study. Bowman, C., Lunyera, J., Alkon, A., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39171639/

Education programmes for people with chronic kidney ... Education programmes probably decrease HbA1c in people with CKD and diabetes, but the effect on other clinical outcomes is unclear. This review ...

2. cdc.gov cdc.gov/kidney-disease/programs/index.html

About the CKD Initiative | Chronic Kidney Disease The system documents CKD and its risk factors in the US population over time. It also monitors the progress of efforts to prevent, detect, and manage CKD.

3. kidney.org kidney.org/professionals/ckdintercept/chronic-kidney-disease-quality-care-begins-measurement

Chronic Kidney Disease: Quality Care Begins with ... Chronic kidney disease is a disease multiplier. It significantly increases risk for cardiovascular events and mortality. Annual testing, early recognition and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0085253825003345

Preventing chronic kidney disease and maintaining ... The primary focus of care for chronic kidney disease (CKD) has been managing progression, complications, and kidney failure after the development of CKD.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK535404/

Chronic Kidney Disease - StatPearls - NCBI Bookshelf CKD is a state of progressive loss of kidney function, ultimately resulting in the need for renal replacement therapy, such as dialysis or transplantation.

6. kidney.org kidney.org/kidney-topics/chronic-kidney-disease-ckd

Chronic kidney disease (CKD) Chronic kidney disease (CKD) is when the kidneys have become damaged over time (for at least 3 months) and have a hard time doing all their important jobs.

7. cdc.gov cdc.gov/kidney-disease/media/pdfs/CKD-Factsheet-H.pdf

Chronic Kidney Disease in the United States, 2023 If kidneys do not work well, toxic waste and extra fluid accumulate in the body and may lead to high blood pressure, heart disease, stroke, and early death.

8. kdigo.org kdigo.org/wp-content/uploads/2024/03/KDIGO-2024-CKD-Guideline.pdf

KDIGO-2024-CKD-Guideline.pdf ... CHRONIC KIDNEY DISEASE (CKD) NOMENCLATURE USED BY KDIGO. CKD is defined as abnormalities of kidney structure or function, present for a minimum of 3 months ...

9. emedicine.medscape.com emedicine.medscape.com/article/238798-overview

Chronic Kidney Disease (CKD) A term that encompasses all degrees of decreased kidney function, from damaged–at risk through mild, moderate, and severe chronic kidney failure.

10. ajkd.org ajkd.org/article/S0272-6386(25)00864-9/fulltext

Safe Patient Care in CKD: Core Curriculum 2025 Patients with chronic kidney disease are at risk for adverse events because of the complexity of this illness and the impact of declining kidney ...