Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01992926
Enrollment
109
Registered
2013-11-25
Start date
2013-11-30
Completion date
2014-08-31
Last updated
2015-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, End Stage Renal Disease

Keywords

health literacy, health numeracy

Brief 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.

Interventions

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

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in patient understanding of anemia and treatment optionsbaseline and 3 monthsChange 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026