Targeting Social Determinants to Improve Chronic Kidney Disease Care

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: interactive educational intervention
    • Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
  • No Intervention: control group
    • Physicians will conduct the standard-of-care clinic visit as usual.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • patient understanding of kidney disease and their disease status
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kerri Cavanaugh, Assistant Professor – Vanderbilt University
  • Overall Official(s)
    • Kerri Cavanaugh, MD, Principal Investigator, Vanderbilt University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.