Targeting Social Determinants to Improve Chronic Kidney Disease Care

Chronic Kidney Disease Clinical Trial

Official title:

Targeting Social Determinants to Improve Chronic Kidney Disease Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604577
• Other study ID #: 120595
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: July 26, 2014
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• interactive educational intervention
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-care of Chronic Kidney Disease	Change from baseline in the following surveys/questionaires at 6 months; Morisky 8-Item Survey; Frequent Food Questionaire	baseline and 6 months	No
Secondary	patient understanding of kidney disease and their disease status	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	baseline and 6 months	No