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

Vanderbilt University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Behavioral: Literacy/Numeracy oriented educational intervention; Behavioral: Control Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00469105

7-04-NN-16 (ADA)

UNC IRB: 06-0535

Vanderbilt IRB: 040387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

110 participants in 2 patient groups

Control

Active Comparator group

Description:

Control Arm receives standard diabetes disease management

Treatment:

Behavioral: Control Group

Intervention Arm

Experimental group

Description:

Receives numeracy/literacy sensitive diabetes management

Treatment:

Behavioral: Literacy/Numeracy oriented educational intervention