Viewing Study NCT00469105



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Study NCT ID: NCT00469105
Status: COMPLETED
Last Update Posted: 2010-04-23
First Post: 2007-05-03

Brief Title: Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Sponsor: Vanderbilt University
Organization: Vanderbilt University

Study Overview

Official Title: Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Status: COMPLETED
Status Verified Date: 2010-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this research will be to perform a small randomized controlled trial RCT of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of primary care patients with type 2 diabetes and low literacy andor numeracy
Detailed Description: Results of the National Adult Literacy Survey NALS suggest that over 90 million adult Americans have poor quantitative skills Numeracy the ability to understand and use numbers and math skills in daily life may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills such as counting carbohydrates interpreting blood glucose monitoring applying sliding scale insulin regimens and calculating insulin to carbohydrate ratios Presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes but to date there are no published studies that rigorously examine the role of numeracy in diabetes We have recently completed the initial development of a new scale to measure numeracy in patients with diabetes the Diabetes Numeracy Test DNT

The aim of this research will be to perform a small randomized controlled trial RCT of a new diabetes educational intervention that teaches self-management skills that compensate for poor literacy and numeracy skills among a sample of patients with type 2 diabetes and low numeracy or literacy skills We hypothesize that a group of patients with poor literacy andor numeracy who are taught self-management skills that accommodate their poor numeracy will have 1 improved treatment satisfaction and perceived self-efficacy 2 improved performance in self-management tasks and 3 improved glycemic control compared to a control group that receives usual education and care

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
UNC IRB 06-0535 None None None
Vanderbilt IRB 040387 None None None