Targeting Social Determinants to Improve Chronic Kidney Disease Care

NCT01604577 | Completed

• 1 other identifier: 120595
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

health literacy; health numeracy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• patient understanding of kidney disease and their disease status

  baseline and 6 months

Study Arms (2)

interactive educational intervention

ACTIVE COMPARATOR

Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.

Behavioral: interactive educational intervention

control group

NO INTERVENTION

Physicians will conduct the standard-of-care clinic visit as usual.

Interventions

interactive educational intervention BEHAVIORAL

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

interactive educational intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerri Cavanaugh, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

US (1)