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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992926
• Other study ID #: 130784
• Status: Completed
• Phase: N/A
• First received: November 14, 2013
• Last updated: January 21, 2015
• Start date: November 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• interactive educational intervention
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in patient understanding of anemia and treatment options	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)	baseline and 3 months	No