Skip to main content
OpenTrials
Completed

NCT Number: NCT01992926

Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial

Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug.

The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has Chronic Kidney Disease or End Stage Renal Disease
  • Over 18, under 80 years of age
  • Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
  • Receiving ESAs for anemia
  • Speaks and can read English (no previous use of interpreter services)
  • No significant visual impairment documented in medical record

Exclusion criteria

  • Diagnosed cognitive disability
  • Stated inability to converse and read fluently in English, or prior use of translation services
  • Poor visual acuity

Treatment and study plan

interactive educational intervention

Behavioral

Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.

Primary outcomes

  1. change in patient understanding of anemia and treatment options

    Time frame: baseline and 3 months

    Change from baseline in the following surveys/questionaires at 3 months:

    • Anemia Knowledge Survey (PAKKD)
    • Perceived Kidney Self-Management Scale (PKiSMS or PDiSMS for ESRD)
    • Social Support Measure (MSPSS)
    • Perceived Efficacy in Patient-Physician Interactions (PEPPI)

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Jan 22, 2015

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.

Published trials that share one or more normalized conditions with this study.