Chronic Kidney DiseasesCKD-EDUNCT03465449
Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients
A study testing CKD-EDU in people with Chronic Kidney Diseases, run by University of Rochester at 1 site in United States.
Trial summary
The investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared… 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?
- CKD-EDU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
- Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
- Speaks English
- Have not attended a dialysis education class or met with the dialysis education coordinator.
- Have not made a dialysis decision
Who cannot join
- Patient has already been seen by a palliative care clinician or is enrolled in hospice
- Is already on dialysis
- Hospitalized at the time of recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients ≥ 75 Years of Age and Their Caregivers (CKD-EDU Study) - A Pilot Study
The investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.
- Conditions
- Chronic Kidney Diseases
- Being tested
- CKD-EDU, usual care
- 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.
CKD-EDUBehavioural
Palliative Care based coaching intervention for support with dialysis-related decision making.
usual careOther
Nephrologist based usual care
| Study group | Role | What they receive |
|---|---|---|
| usual care | Active comparator | Not described Receives: Other: usual care |
| CKD-EDU arm | Experimental | Not described Receives: Behavioral: CKD-EDU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving the intervention
We'll assess feasibility by determining the reach of the intervention
Measured: 24 months
Acceptability of the intervention
We'll assess the acceptability of the CKD-PC intervention by qualitative interviews by reporting the percentage of patients with a favorable response to the intervention.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start31 May 2018
- Primary completion9 Feb 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Fahad Saeed, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465449
- Sponsor's protocol ID
- 0071204
- Acronym
- CKD-EDU
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2018
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saeed F, Horowitz RK, Allen RJ, Auinger P, Epstein RM, Fiscella KA, Veazie PJ, Duberstein PR. Feasibility and Acceptability of a Palliative Care Intervention among Older Adults with Advanced CKD and Their Caregivers. Kidney360. 2025 Feb 1;6(2):236-246. doi: 10.34067/KID.0000000622. Epub 2024 Oct 24.
PubMed 40014547
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients ≥ 75 Years of Age and Their Caregivers (CKD-EDU Study) - A Pilot Study
- ClinicalTrials.gov ID
- NCT03465449
- Acronym / sponsor ID
- CKD-EDU / 0071204
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 14 Mar 2018 (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 studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | Active comparator | Other: usual care |
| CKD-EDU arm | Experimental | Behavioral: CKD-EDU |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥75 years old
- Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
- Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
- Speaks English
- Have not attended a dialysis education class or met with the dialysis education coordinator.
Key exclusion criteria (3 listed)
- Patient has already been seen by a palliative care clinician or is enrolled in hospice
- Is already on dialysis
- Hospitalized at the time of recruitment
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 |
|---|---|---|
| CKD-EDUPalliative Care based coaching intervention for support with dialysis-related decision making. | Behavioural | CKD-EDU arm |
| usual careNephrologist based usual care | Other | usual care |
Primary outcome
Number of participants receiving the intervention
Time frame: 24 months
We'll assess feasibility by determining the reach of the intervention
Acceptability of the intervention
Time frame: 24 months
We'll assess the acceptability of the CKD-PC intervention by qualitative interviews by reporting the percentage of patients with a favorable response to the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 40014547Saeed F, Horowitz RK, Allen RJ, Auinger P, Epstein RM, Fiscella KA, Veazie PJ, Duberstein PR. Feasibility and Acceptability of a Palliative Care Intervention among Older Adults with Advanced CKD and Their Caregivers. Kidney360. 2025 Feb 1;6(2):236-246. doi: 10.34067/KID.0000000622. Epub 2024 Oct 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CKD-EDU in people with Chronic Kidney Diseases, run by University of Rochester at 1 site 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants receiving the intervention (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465449, which also lists 1 linked publication.
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 12 Oct 2022.