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CompletedNCT03465449CKD-EDUUpdated Oct 12, 2022

Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients

An interventional study of CKD-EDU and usual care in Chronic Kidney Diseases, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Diseases
03

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥75 years old
  2. Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
  3. Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
  4. Speaks English
  5. Have not attended a dialysis education class or met with the dialysis education coordinator.
  6. Have not made a dialysis decision

Exclusion criteria

Exclusion Criteria:

  1. Patient has already been seen by a palliative care clinician or is enrolled in hospice
  2. Is already on dialysis
  3. Hospitalized at the time of recruitment
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    usual care

    Other: usual care

  • Experimental
    CKD-EDU arm

    Behavioral: CKD-EDU

Interventions

  • BehavioralCKD-EDU

    Palliative Care based coaching intervention for support with dialysis-related decision making.

  • Otherusual care

    Nephrologist based usual care

05

What researchers measure

Primary outcomes

  1. Number of participants receiving the intervention

    We'll assess feasibility by determining the reach of the intervention

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

06

Study locations

1 site
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03465449
Lead sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
Responsible party
Fahad Saeed (Assistant professor of medicine, University of Rochester) — Principal investigator
First posted
Mar 14, 2018
Start date
May 31, 2018
Primary completion
Feb 9, 2021
Completion
Aug 30, 2022
Last update
Oct 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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