Targeting Social Determinants to Improve Chronic Kidney Disease Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kerri Cavanaugh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01604577
First received: May 21, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Vanderbilt University:

Primary Outcome Measures:
  • self-care of Chronic Kidney Disease [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 350
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604577

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

No publications provided

Responsible Party: Kerri Cavanaugh, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01604577     History of Changes
Other Study ID Numbers: 120595
Study First Received: May 21, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
health literacy
health numeracy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 15, 2014