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NCT01604577 · ClinicalTrials.gov registry record · NA

Targeting Social Determinants to Improve Chronic Kidney Disease Care

A NA study, sponsored by Vanderbilt University.

Completed
Registry status
NA
Development phase
273
Enrollment target

NCT01604577: Completed NA study, sponsored by Vanderbilt University.

NCT01604577 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 273 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01604577, a NA study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
NA
Development phase
273 participants
Enrollment target

Study 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.

Primary Outcome

Change from baseline in the following surveys/questionaires at 6 months * Morisky 8-Item Survey * Frequent Food Questionaire

Interventions

  • BEHAVIORAL interactive educational intervention

Trial Details

FieldValue
Enrollment Target 273 participants
Start Date 2012-05
Est. Completion 2013-06
Phase NA
Vanderbilt University

430 total trials

What the finished NCT01604577 record still lists

NCT01604577 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 1 intervention - of which interactive educational intervention is the first listed.

NCT01604577 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01604577 about?

NCT01604577 is a clinical study titled "Targeting Social Determinants to Improve Chronic Kidney Disease Care". 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 ed...

What is the current status of trial NCT01604577?

This trial is currently completed. It is a NA study. The enrollment target is 273 participants. The study started on 2012-05. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01604577?

The interventions under investigation include: interactive educational intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT01604577?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01604577's enrollment target sits among peer trials

273 386th of 2000 higher than 1,614 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01604577, the US trial registry maintained by the National Library of Medicine. NCT01604577 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.