Chronic Kidney Disease Clinical Trial
Official title:
Targeting Social Determinants to Improve Chronic Kidney Disease Care
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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