Clinical trial NCT01604577: Targeting Social Determinants to Improve Chronic Kidney Disease Care
Official title: Targeting Social Determinants to Improve Chronic Kidney Disease Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: health literacy
health numeracy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: self-care of Chronic Kidney Disease
timeFrame: baseline and 6 months
Secondary outcomes:
measure: patient understanding of kidney disease and their disease status
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Kerri Cavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
References: