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Targeting Social Determinants to Improve Chronic Kidney Disease Care

This study has been completed.
Information provided by (Responsible Party):
Kerri Cavanaugh, Vanderbilt University Identifier:
First received: May 21, 2012
Last updated: July 26, 2014
Last verified: July 2014

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.

Condition Intervention
Chronic Kidney Disease Behavioral: interactive educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Social Determinants to Improve Chronic Kidney Disease Care

Resource links provided by NLM:

Further study details as provided by Kerri Cavanaugh, Vanderbilt University:

Primary Outcome 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 Outcome 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

Enrollment: 273
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01604577

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Kerri Cavanaugh, MD Vanderbilt University
  More Information

Responsible Party: Kerri Cavanaugh, Assistant Professor, Vanderbilt University Identifier: NCT01604577     History of Changes
Other Study ID Numbers: 120595
Study First Received: May 21, 2012
Last Updated: July 26, 2014

Keywords provided by Kerri Cavanaugh, Vanderbilt University:
health literacy
health numeracy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on September 21, 2017