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Targeting Social Determinants to Improve Chronic Kidney Disease Care

Targeting Social Determinants to Improve Chronic Kidney Disease Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01604577
Enrollment
273
Registered
2012-05-23
Start date
2012-05-31
Completion date
2013-06-30
Last updated
2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

health literacy, health numeracy

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.

Interventions

Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
self-care of Chronic Kidney Diseasebaseline and 6 monthsChange from baseline in the following surveys/questionaires at 6 months * Morisky 8-Item Survey * Frequent Food Questionaire

Secondary

MeasureTime frameDescription
patient understanding of kidney disease and their disease statusbaseline and 6 monthsChange from baseline in the following surveys/questionaires at 6 months * Kidney Awareness & Knowledge Survey * Perceived Kidney Self-Management Scale * Kidney Disease Self-Management Behaviors

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026