Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program

NCT ID: NCT03229811

Last Updated: 2025-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-24

Study Completion Date

2021-12-14

Brief Summary

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The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD.

Detailed Description

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This intervention will be randomized among patients with advanced chronic kidney disease.

Conditions

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Advance Care Planning Chronic Kidney Diseases Conservative Kidney Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard pre-dialysis education

Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

ESRD education + ACP

Standard ESRD education + conservative kidney management and advance care planning education

Group Type ACTIVE_COMPARATOR

ESRD education + conservative kidney management and ACP education

Intervention Type OTHER

Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers

Interventions

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ESRD education + conservative kidney management and ACP education

Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR \< 30 ml/min/1.73m2)
* Age 65 years or greater or frail
* self-reported Black or White race

Exclusion Criteria

* History of dementia
* History of legal blindness
* Listed for kidney transplantation
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Nwamaka Eneanya, MD, MPH

Attending Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Stallings TL, Temel JS, Klaiman TA, Paasche-Orlow MK, Alegria M, O'Hare A, O'Connor N, Dember LM, Halpern SD, Eneanya ND. Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e042620. doi: 10.1136/bmjopen-2020-042620.

Reference Type DERIVED
PMID: 33619188 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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831500

Identifier Type: -

Identifier Source: org_study_id

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