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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469105
• Other study ID #: 7-04-NN-16 (ADA)
• Secondary ID: Vanderbilt IRB:
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2007
• Last updated: April 22, 2010
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2010
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Literacy/Numeracy oriented educational intervention
Receives comprehensive literacy/num sensitive diabetes care
• Control Group
Receives standard diabetes disease management

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, General Medicine Clinic	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Vanderbilt University	American Diabetes Association, Pfizer, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1C		3 and 6 months	No
Secondary	Patient self-management behaviors		3 and 6 months	No
Secondary	Patient knowledge		6 months	No
Secondary	Patient satisfaction		6 months	No