Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients
CKD-EDU
1 other identifier
interventional
58
1 country
1
Brief 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 decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedStudy Start
First participant enrolled
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedOctober 12, 2022
October 1, 2022
2.7 years
March 7, 2018
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants receiving the intervention
We'll assess feasibility by determining the reach of the intervention
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.
24 months
Study Arms (2)
usual care
ACTIVE COMPARATORCKD-EDU arm
EXPERIMENTALInterventions
Palliative Care based coaching intervention for support with dialysis-related decision making.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
Related Publications (1)
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.
PMID: 40014547DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of medicine
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
May 31, 2018
Primary Completion
February 9, 2021
Study Completion
August 30, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share