Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Control Group; Behavioral: Literacy/Numeracy oriented educational intervention

• Registration Number: NCT00469105
• Lead Sponsor: Vanderbilt University

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 and/or 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 and/or 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 Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Clinical diagnosis of Type 2 Diabetes
2. most recent A1C >= 7.5%
3. Referred to the Diabetes Care Program for diabetes care
4. Age 18-85; 5. English Speaking.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Control Group	Control Arm receives standard diabetes disease management
Intervention Arm	Literacy/Numeracy oriented educational intervention	Receives numeracy/literacy sensitive diabetes management

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)

University of North Carolina at Chapel Hill, General Medicine Clinic; 🇺🇸 Chapel Hill, North Carolina, United States