Chronic Kidney Disease-Education (CKD-EDU)

NCT ID: NCT06410144

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2029-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Research coordinators responsible for administering assessments will remain blinded to the patient's randomization status.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Program A

Kidney therapy education and support with kidney therapy educator.

Group Type ACTIVE_COMPARATOR

Program A

Intervention Type BEHAVIORAL

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

Program B

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

Group Type ACTIVE_COMPARATOR

Program B

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Program A

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CKD-EDU Intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fahad Saeed

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fahad Saeed, MBBS, MSCI

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UR Medicine Nephrology - Strong West

Brockport, New York, United States

Site Status RECRUITING

Nephrology Clinic - Thompson Professional Building

Canandaigua, New York, United States

Site Status RECRUITING

Nephrology Clinic - St. James Medical Office Building

Hornell, New York, United States

Site Status RECRUITING

Highland Hospital

Rochester, New York, United States

Site Status RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brooke Study Coordinator

Role: CONTACT

585-275-7033

Allison Study Coordinator

Role: CONTACT

585-210-2515

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Brooke Study Coordinator

Role: primary

585-275-7033

Allison Study Coordinator

Role: backup

585-210-2515

Brooke Study Coordinator

Role: primary

585-275-7033

Allison Study Coordinator

Role: backup

585-210-2515

Brooke Study Coordinator

Role: primary

585-275-7033

Allison Study Coordinator

Role: backup

585-210-2515

Brooke Study Coordinator

Role: primary

585-275-7033

Allison Study Coordinator

Role: backup

585-210-2515

Brooke Study Coordinator

Role: primary

585-275-7033

Allison Study Coordinator

Role: backup

585-210-2515

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AG082891

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009330

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Kidney Health: Eat Well, Live Well
NCT05970341 RECRUITING NA
Health Outcomes Patient Education
NCT02976220 COMPLETED NA