Chronic Kidney DiseasesCKD-EDUNCT06410144
Chronic Kidney Disease-Education (CKD-EDU)
A study testing Program A and Program B in people with Chronic Kidney Diseases, run by University of Rochester at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Program A and Program B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Feb 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 years old
- Has advanced kidney disease with kidney function less than 30%
- Speaks English
- Has not yet made a dialysis decision
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
UR Medicine Nephrology - Strong West
Brockport, New York, 14420
Brooke Study Coordinator, 585-275-7033, KidneyEducation@urmc.rochester.edu
Allison Study Coordinator, 585-210-2515, KidneyEducation@urmc.rochester.edu
- Recruiting
Nephrology Clinic - Thompson Professional Building
Canandaigua, New York, 14424
Brooke Study Coordinator, 585-275-7033, KidneyEducation@urmc.rochester.edu
Allison Study Coordinator, 585-210-2515, KidneyEducation@urmc.rochester.edu
- Recruiting
Nephrology Clinic - St. James Medical Office Building
Hornell, New York, 14843
Brooke Study Coordinator, 585-275-7033, KidneyEducation@urmc.rochester.edu
Allison Study Coordinator, 585-210-2515, KidneyEducation@urmc.rochester.edu
- Recruiting
Highland Hospital
Rochester, New York, 14620
Brooke Study Coordinator, 585-275-7033, KidneyEducation@urmc.rochester.edu
Allison Study Coordinator, 585-210-2515, KidneyEducation@urmc.rochester.edu
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Brooke Study Coordinator, 585-275-7033, KidneyEducation@urmc.rochester.edu
Allison Study Coordinator, 585-210-2515, KidneyEducation@urmc.rochester.edu
About this study
Official title: Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Program A, Program B
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program ABehavioural
Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.
Program BBehavioural
Also called CKD-EDU Intervention
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 group | Role | What they receive |
|---|---|---|
| Program A | Active comparator | Kidney therapy education and support with kidney therapy educator. Receives: Behavioral: Program A |
| Program B | Active comparator | Behavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making. Receives: Behavioral: Program B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Determine whether the intervention improves patient well-being at 6 months using the Burden of Kidney Disease Subscale, a 4-question scale with response options ranging from 'definitely true (0)' to 'definitely false (3)'. Higher scores indicate better outcomes.
Measured: Base line 6 months
Changes in number of hospital admissions, intensive care admissions, and emergency room visits
Review electronic health records to determine whether the intervention reduces the number of hospital admissions, intensive care admissions, and emergency room visits between study entry and 6 months.
Measured: Baseline, 6 months
Differences in end-of-life care between intervention and control arm
Review patients' medical charts to determine whether the intervention improves end-of-life care treatment during the last 30 days of life, as measured by the rates of aggressive procedures such as cardiopulmonary resuscitation (CPR), dialysis, intubation, gastrostomy (G-tube), etc.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start27 Feb 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Fahad Saeed, University of Rochester
- Investigators
- Fahad Saeed, MBBS, MSCI, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410144
- Sponsor's protocol ID
- STUDY00009330
- Other IDs
- R01AG082891
- Acronym
- CKD-EDU
- Status last verified
- Apr 2026
- First submitted
- 2 May 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified qualitative data will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT06410144
- Acronym / sponsor ID
- CKD-EDU / STUDY00009330
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program A | Active comparator | Behavioral: Program AKidney therapy education and support with kidney therapy educator. |
| Program B | Active comparator | Behavioral: Program BBehavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 75 years old
- Has advanced kidney disease with kidney function less than 30%
- Speaks English
- Has not yet made a dialysis decision
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program ASubjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator. | Behavioural | Program A |
| Program BAlso: CKD-EDU InterventionSubjects 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. | Behavioural | Program B |
Primary outcome
Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks
Time frame: Baseline, 4-6 weeks, and 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Only de-identified qualitative data will be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fahad Saeed, MBBS, MSCI principal investigator
University of Rochester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program A and Program B in people with Chronic Kidney Diseases, run by University of Rochester at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brooke Study Coordinator (585-275-7033, KidneyEducation@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.