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Clinical Trials/NCT01604577
NCT01604577
Completed
Not Applicable

Targeting Social Determinants to Improve Chronic Kidney Disease Care

Vanderbilt University1 site in 1 country273 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Vanderbilt University
Enrollment
273
Locations
1
Primary Endpoint
self-care of Chronic Kidney Disease
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
June 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kerri Cavanaugh

Assistant Professor

Vanderbilt University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

self-care of Chronic Kidney Disease

Time Frame: baseline and 6 months

Change from baseline in the following surveys/questionaires at 6 months * Morisky 8-Item Survey * Frequent Food Questionaire

Secondary Outcomes

  • patient understanding of kidney disease and their disease status(baseline and 6 months)

Study Sites (1)

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