Chronic Kidney Disease-Education (CKD-EDU) (CKD-EDU)

April 29, 2026 updated by: Fahad Saeed, University of Rochester

Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.

Study Type

Interventional

Enrollment (Estimated)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 75 years old
  • Has advanced kidney disease with kidney function less than 30%
  • Speaks English
  • Has not yet made a dialysis decision

Exclusion Criteria:

  • Has already decided on dialysis or active medical care without dialysis.
  • Has already been seen by a Palliative Care (PC) clinician for kidney-related issues or is enrolled in hospice
  • Currently on dialysis
  • Unable to provide informed consent or complete verbally administered surveys due to health, sensory, or cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Program A
Kidney therapy education and support with kidney therapy educator.
Behavioral: Program A
Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.
Active Comparator: Program B
Behavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making.
Behavioral: Program B
Subjects in the intervention group will receive 1) a video and paper decision aid, and 2) coaching from a decision support specialist. The visits will be aimed at supporting patients with kidney therapy decision-making.
Other Names:
  • CKD-EDU Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks
Time Frame: Baseline, 4-6 weeks, and 12 weeks
Determine whether the intervention improves kidney therapy decision-making at 12 weeks by using the Decisional Conflict Scale. Score ranges from 0-100. Lower scores indicate better outcomes.
Baseline, 4-6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale
Time Frame: Base line 6 months
Determine whether the intervention improves patient well-being at 6 months using the Burden of Kidney Disease Subscale, a 4-question scale with response options ranging from 'definitely true (0)' to 'definitely false (3)'. Higher scores indicate better outcomes.
Base line 6 months
Changes in number of hospital admissions, intensive care admissions, and emergency room visits
Time Frame: Baseline, 6 months
Review electronic health records to determine whether the intervention reduces the number of hospital admissions, intensive care admissions, and emergency room visits between study entry and 6 months.
Baseline, 6 months
Differences in end-of-life care between intervention and control arm
Time Frame: Baseline to 6 months
Review patients' medical charts to determine whether the intervention improves end-of-life care treatment during the last 30 days of life, as measured by the rates of aggressive procedures such as cardiopulmonary resuscitation (CPR), dialysis, intubation, gastrostomy (G-tube), etc.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Fahad Saeed, MBBS, MSCI, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009330
  • R01AG082891 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only de-identified qualitative data will be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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