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

NCT ID: NCT03465449

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2022-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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usual care

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Nephrologist based usual care

CKD-EDU arm

Group Type EXPERIMENTAL

CKD-EDU

Intervention Type BEHAVIORAL

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

Interventions

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CKD-EDU

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

Intervention Type BEHAVIORAL

usual care

Nephrologist based usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Fahad Saeed

Assistant professor of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40014547 (View on PubMed)

Other Identifiers

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0071204

Identifier Type: -

Identifier Source: org_study_id

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