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

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CKD-EDU
usual care
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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:

  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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual care

CKD-EDU arm

Arm Description

Outcomes

Primary Outcome Measures

Number of participants receiving the intervention
We'll assess feasibility by determining the reach of the intervention
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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
October 10, 2022
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03465449
Brief Title
Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients
Acronym
CKD-EDU
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
Active Comparator
Arm Title
CKD-EDU arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CKD-EDU
Intervention Description
Palliative Care based coaching intervention for support with dialysis-related decision making.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Nephrologist based usual care
Primary Outcome Measure Information:
Title
Number of participants receiving the intervention
Description
We'll assess feasibility by determining the reach of the intervention
Time Frame
24 months
Title
Acceptability of the intervention
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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