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Targeting Social Determinants to Improve Chronic Kidney Disease Care

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Vanderbilt University

Status

Completed

Conditions

Chronic Kidney Disease

Treatments

Behavioral: interactive educational intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

273 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

273 participants in 2 patient groups

interactive educational intervention
Active Comparator group
Description:
Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
Treatment:
Behavioral: interactive educational intervention
control group
No Intervention group
Description:
Physicians will conduct the standard-of-care clinic visit as usual.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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