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

Trial Summary

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 data supports the effectiveness of the treatment CKD-EDU for kidney disease?

Research shows that educational programs for kidney disease patients can improve their quality of life, increase their knowledge about the disease, and enhance self-care practices. These programs have been linked to better health outcomes, such as improved kidney function and reduced use of medical services. ^{1 2 3 4 5}

Is the CKD-EDU educational program safe for humans?

The research does not provide specific safety data for the CKD-EDU educational program, but it highlights that patients with chronic kidney disease (CKD) are at high risk for safety issues due to the complexity of their care and medication errors. This suggests the importance of careful management and monitoring in CKD care. ^{6 7 8 9 10}

How is the CKD-EDU treatment different from other treatments for chronic kidney disease?

The CKD-EDU treatment is unique because it focuses on education to help patients manage their chronic kidney disease, rather than using medication. This approach involves teaching patients about their condition and how to slow its progression, which has been shown to improve clinical outcomes and slow the decline in kidney function. ^{11 12 13 14 15}

What is the purpose of this trial?

The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults. Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions. Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.

Research Team

Fahad Saeed, MD

Principal Investigator

University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Effect of multi-dimensional education on disease progression in pre-dialysis patients in China. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

An educational project for patients on hemodialysis to promote self-management behaviors of end stage renal disease education. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient perception of risk factors associated with chronic kidney disease morbidity and mortality. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of a face-to-face self-management program on knowledge, self-care practice and kidney function in patients with chronic kidney disease before the renal replacement therapy. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

A Patient Safety Educational Tool for Patients With Chronic Kidney Disease: Development and Usability Study. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

DaVita program advocates self-management of CKD. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

The National Kidney Disease Education Program: improving understanding, detection, and management of CKD. [2009]

13. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Kidney Disease Education on Clinical Outcomes and Knowledge of Self-Management Behaviors of Patients with Chronic Kidney Disease. [2015]

14. United States pubmed.ncbi.nlm.nih.gov

Educational Interventions for Patients With CKD: A Systematic Review. [2022]

15. Japan pubmed.ncbi.nlm.nih.gov

An inpatient educational program for chronic kidney disease. [2021]