Improving Care for Patients With Diabetes and Poor Numeracy Skills

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Control Group; Behavioral: Literacy/Numeracy oriented educational intervention

• Registration Number: NCT00311922
• Lead Sponsor: Vanderbilt University

Brief Summary

The aim of this research will be to perform a 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 patients with diabetes and low 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 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 patients with diabetes and low numeracy. We hypothesize that a group of patients with poor 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-15
• Last Update Posted: 2008-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Clinical diagnosis of Type 1 or 2 Diabetes;
2. most recent A1C greater than or equal to 7.0%;
3. Referred to the Diabetes Improvement Program for diabetes care;
4. Age 18-80;
5. English Speaking.

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Exclusion Criteria

1. Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or
2. Patients with a diagnosis of significant dementia, psychosis, or blindness.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Control Group	Active Control Arm receives Comprehensive Diabetes Education
Intervention Arm	Literacy/Numeracy oriented educational intervention	Receives comprehensive education that is literacy/numeracy sensitive

Primary Outcome Measures

Name	Time	Method
A1C	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Patient self-management behaviors	3 and 6 months
Patient knowledge	6 months
Patient satisfaction	6 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States