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

October 6, 2022 updated by: Nwamaka Eneanya, MD, MPH, University of Pennsylvania
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard pre-dialysis education
Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation
Active Comparator: ESRD education + ACP
Standard ESRD education + conservative kidney management and advance care planning education
Other: ESRD education + conservative kidney management and ACP education
Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of conservative kidney management and advance care planning
Time Frame: Baseline and Day 1 post-intervention
Change in knowledge of conservative kidney management and advance care planning (mean score)
Baseline and Day 1 post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication of EOL preferences with healthcare providers and family members
Time Frame: 12 weeks post-intervention
Binary outcome (yes/no)
12 weeks post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of healthcare proxy forms, living wills, and POLST forms
Time Frame: Day 1 post intervention and 12 weeks post-intervention
Binary outcome (yes/no)
Day 1 post intervention and 12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2021

Primary Completion (Actual)

December 14, 2021

Study Completion (Actual)

December 14, 2021

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 831500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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