Recruiting

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

Sponsor:

University of Rochester

Code:

NCT06410144

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Program A

Program B

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Diseases

Study ID

NCT06410144

Start date

Feb 27, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

326 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Program A

Kidney therapy education and support with kidney therapy educator.

active comparator: Program B

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

Interventions

Program A

Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.

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.

Primary outcome measure

Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks [ Time Frame: Baseline, 4-6 weeks, and 12 weeks ]

Central Contacts and Locations

Central contacts

Brooke Study Coordinator

585-275-7033 KidneyEducation@urmc.rochester.edu

Allison Study Coordinator

585-210-2515 KidneyEducation@urmc.rochester.edu

Locations

UR Medicine Nephrology - Strong West

Recruiting

Brockport, New York, United States, 14420

Contacts

Brooke Study Coordinator

585-275-7033 KidneyEducation@urmc.rochester.edu

Allison Study Coordinator

585-210-2515 KidneyEducation@urmc.rochester.edu

Nephrology Clinic - Thompson Professional Building

Recruiting

Canandaigua, New York, United States, 14424

Contacts

Brooke Study Coordinator

585-275-7033 KidneyEducation@urmc.rochester.edu

Allison Study Coordinator

585-210-2515 KidneyEducation@urmc.rochester.edu

Nephrology Clinic - St. James Medical Office Building

Recruiting

Hornell, New York, United States, 14843

Contacts

Brooke Study Coordinator

585-275-7033 KidneyEducation@urmc.rochester.edu

Allison Study Coordinator

585-210-2515 KidneyEducation@urmc.rochester.edu

Highland Hospital

Recruiting

Rochester, New York, United States, 14620

Contacts

Brooke Study Coordinator

585-275-7033 KidneyEducation@urmc.rochester.edu

Allison Study Coordinator

585-210-2515 KidneyEducation@urmc.rochester.edu

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Brooke Study Coordinator

585-275-7033 KidneyEducation@urmc.rochester.edu

Allison Study Coordinator

585-210-2515 KidneyEducation@urmc.rochester.edu

Principal Investigator:

Fahad Saeed, MBBS

More Information

Sponsor

University of Rochester

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-05-05.