Chronic Kidney Disease-Education (CKD-EDU)

NCT06410144 | Recruiting

• 2 other identifiers: STUDY00009330R01AG082891
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 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 Outcomes (3)

• Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale

  Base line 6 months

• Changes in number of hospital admissions, intensive care admissions, and emergency room visits

  Baseline, 6 months

• Differences in end-of-life care between intervention and control arm

  Baseline to 6 months

Study Arms (2)

Program A

ACTIVE COMPARATOR

Kidney therapy education and support with kidney therapy educator.

Behavioral: Program A

Program B

ACTIVE COMPARATOR

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

Behavioral: Program B

Interventions

Program A BEHAVIORAL

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

Program A

Program B 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.

Also known as: CKD-EDU Intervention

Program B

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (5)

UR Medicine Nephrology - Strong West

Brockport, New York, 14420, United States

RECRUITING

Nephrology Clinic - Thompson Professional Building

Canandaigua, New York, 14424, United States

RECRUITING

Nephrology Clinic - St. James Medical Office Building

Hornell, New York, 14843, United States

RECRUITING

Highland Hospital

Rochester, New York, 14620, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Medicare Part A

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicare; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal

Study Officials

• Fahad Saeed, MBBS, MSCI

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Study Coordinator

CONTACT

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

Allison Study Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research coordinators responsible for administering assessments will remain blinded to the patient's randomization status.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 13, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)