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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01992926
First Posted: November 25, 2013
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kerri Cavanaugh, Vanderbilt University
  Purpose

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.


Condition Intervention
Chronic Kidney Disease End Stage Renal Disease Behavioral: interactive educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial

Resource links provided by NLM:


Further study details as provided by Kerri Cavanaugh, Vanderbilt University:

Primary Outcome Measures:
  • 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)


Enrollment: 109
Study Start Date: November 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: interactive educational intervention
Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
Behavioral: interactive educational intervention
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
No Intervention: control group
Physicians will conduct the standard-of-care clinic visit as usual.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992926


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Kerri Cavanaugh, MD Vanderbilt University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kerri Cavanaugh, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01992926     History of Changes
Other Study ID Numbers: 130784
First Submitted: November 14, 2013
First Posted: November 25, 2013
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Kerri Cavanaugh, Vanderbilt University:
health literacy
health numeracy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency