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

Chronic Kidney Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465449
• Other study ID #: 0071204
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 30, 2022
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Other:
• usual care
Nephrologist based usual care

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants receiving the intervention	We'll assess feasibility by determining the reach of the intervention	24 months
Primary	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