Chronic Kidney Disease-Education (CKD-EDU)

Part of paid clinical trials in Brockport, New York.

Sponsor
University of Rochester
Study ID
NCT06410144
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

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 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.

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
326 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (5)

FacilityCityStateZIPSite coordinators
UR Medicine Nephrology - Strong WestBrockportNew York14420
Brooke Study Coordinator
[email protected]
585-275-7033
Allison Study Coordinator
[email protected]
585-210-2515
Nephrology Clinic - Thompson Professional BuildingCanandaiguaNew York14424
Brooke Study Coordinator
[email protected]
585-275-7033
Allison Study Coordinator
[email protected]
585-210-2515
Nephrology Clinic - St. James Medical Office BuildingHornellNew York14843
Brooke Study Coordinator
[email protected]
585-275-7033
Allison Study Coordinator
[email protected]
585-210-2515
Highland HospitalRochesterNew York14620
Brooke Study Coordinator
[email protected]
585-275-7033
Allison Study Coordinator
[email protected]
585-210-2515
University of Rochester Medical CenterRochesterNew York14642
Brooke Study Coordinator
[email protected]
585-275-7033
Allison Study Coordinator
[email protected]
585-210-2515
Fahad Saeed, MBBS (PRINCIPAL_INVESTIGATOR)

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UR Medicine Nephrology - Strong West· Brockport, NYNephrology Clinic - Thompson Professional Building· Canandaigua, NYNephrology Clinic - St. James Medical Office Building· Hornell, NYHighland Hospital· Rochester, NYUniversity of Rochester Medical Center· Rochester, NY

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