Targeting Social Determinants to Improve Chronic Kidney Disease Care

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Behavioral: interactive educational intervention

• Registration Number: NCT01604577
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-26
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interactive educational intervention	interactive educational intervention	Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
patient understanding of kidney disease and their disease status	baseline and 6 months	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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States