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OpenTrials
Completed

NCT Number: NCT03465449

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥75 years old
  • Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
  • Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
  • Speaks English
  • Have not attended a dialysis education class or met with the dialysis education coordinator.
  • Have not made a dialysis decision

Exclusion criteria

  • Patient has already been seen by a palliative care clinician or is enrolled in hospice
  • Is already on dialysis
  • Hospitalized at the time of recruitment

Treatment and study plan

CKD-EDU

Behavioral

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

Usual Care

Other

Nephrologist based usual care

Primary outcomes

  1. Number of participants receiving the intervention

    Time frame: 24 months

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

  2. Acceptability of the intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study 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

Acronym: CKD-EDU

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 14, 2018
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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