Targeting Social Determinants to Improve Chronic Kidney Disease Care

NCT ID: NCT01604577

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interactive educational intervention

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

Group Type: ACTIVE_COMPARATOR

interactive educational intervention

Intervention Type: BEHAVIORAL

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

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

interactive educational intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Kerri Cavanaugh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerri Cavanaugh, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

120595

Identifier Type: -

Identifier Source: org_study_id