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Trial record 15 of 27 for:    Open Studies | "Health Literacy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Kerri Cavanaugh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01992926
First received: November 14, 2013
Last updated: July 26, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Vanderbilt University:

Primary Outcome Measures:
  • change in patient understanding of anemia and treatment options [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

    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)


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992926

Contacts
Contact: Kerri Cavanaugh, MD 615-936-7306 kerri.cavanaugh@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Marcus Wild    615-875-2737    marcus.wild@vanderbilt.edu   
Principal Investigator: Kerri Cavanaugh, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Kerri Cavanaugh, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Kerri Cavanaugh, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01992926     History of Changes
Other Study ID Numbers: 130784
Study First Received: November 14, 2013
Last Updated: July 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
health literacy
health numeracy

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

ClinicalTrials.gov processed this record on November 25, 2014