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

Sponsor
University of Rochester (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03465449
Collaborator
National Institutes of Health (NIH) (NIH)
58
Enrollment
1
Location
2
Arms
51
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CKD-EDU
  • Other: usual care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
May 31, 2018
Actual Primary Completion Date :
Feb 9, 2021
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: usual care

Other: usual care
Nephrologist based usual care
Experimental: CKD-EDU arm

Behavioral: CKD-EDU
Palliative Care based coaching intervention for support with dialysis-related decision making.

Outcome Measures

Primary Outcome Measures

  1. Number of participants receiving the intervention [24 months]

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

  2. Acceptability of the intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
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:

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Medical Center Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester
  • National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fahad Saeed, Assistant professor of medicine, University of Rochester
ClinicalTrials.gov Identifier:
NCT03465449
Other Study ID Numbers:
  • 0071204
First Posted:
Mar 14, 2018
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 14, 2022