Chronic Kidney Disease-Education (CKD-EDU)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Program A, Program B.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)
Overview
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
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.
Interventions
- Behavioral Program A
Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator. - 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.
Primary outcome measures
- Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks [Time frame: Baseline, 4-6 weeks, and 12 weeks]
Secondary outcome measures (3)
- Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale [Time frame: Base line 6 months]
- Changes in number of hospital admissions, intensive care admissions, and emergency room visits [Time frame: Baseline, 6 months]
- Differences in end-of-life care between intervention and control arm [Time frame: Baseline to 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 5 centers
- UR Medicine Nephrology - Strong West — Brockport
- Nephrology Clinic - Thompson Professional Building — Canandaigua
- Nephrology Clinic - St. James Medical Office Building — Hornell
- Highland Hospital — Rochester
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT06410144 · STUDY00009330 · R01AG082891