Targeting Social Determinants to Improve Chronic Kidney Disease Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kerri Cavanaugh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01604577
First received: May 21, 2012
Last updated: July 26, 2014
Last verified: July 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


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 26, 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
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014