Targeting Social Determinants to Improve Chronic Kidney Disease Care

The primary research goals of this application are to characterize social factors including health literacy and numeracy skills of CKD patients and examine associations with knowledge, self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an efficient interactive educational intervention to facilitate patient-provider communication. The investigators will accomplish these goals by executing a cluster-randomized controlled trial and performing detailed analysis of baseline measures. The specific aims of this study are:

Specific Aim 1: Determine the association of social factors with patient kidney knowledge, self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to advanced CKD.

Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated with older age, non-white race, fewer years of education, lower socioeconomic (income) status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with medication and diet self-care recommendations. Low literacy/numeracy is also associated with higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.

Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used cooperatively by physicians and patients to improve self-care and outcomes in CKD.

Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool will be feasible and associated with higher patient kidney knowledge, self-efficacy of self-care and greater adherence to medication and nutrition recommendations compared to usual care.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: interactive educational intervention

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Receiving care in the Vanderbilt General Nephrology Clinic for at least 1 prior visit past 12 months;
• Serum creatinine available in the medical record in the last 12 months demonstrating Chronic Kidney Disease (eGFR<60mls/min);
• Age 18-80 years;
• English-speaking.

Exclusion Criteria:

• Pre-existing diagnosis of significant dementia or psychosis as determined by primary provider and documented in the medical record;
• Corrected visual Acuity >60/20 using a Rosenbaum Pocket Vision Screen;
• Patient receives dialysis or has a functional kidney transplant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-care of Chronic Kidney Disease	Change from baseline in the following surveys/questionaires at 6 months; Morisky 8-Item Survey; Frequent Food Questionaire	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient understanding of kidney disease and their disease status	Change from baseline in the following surveys/questionaires at 6 months; Kidney Awareness & Knowledge Survey; Perceived Kidney Self-Management Scale; Kidney Disease Self-Management Behaviors	baseline and 6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Kerri Cavanaugh, MD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 26, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: health literacy; health numeracy
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 120595