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

NCT ID: NCT00469105

Last Updated: 2010-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Control

Control Arm receives standard diabetes disease management

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: BEHAVIORAL

Receives standard diabetes disease management

Intervention Arm

Receives numeracy/literacy sensitive diabetes management

Group Type: EXPERIMENTAL

Literacy/Numeracy oriented educational intervention

Intervention Type: BEHAVIORAL

Receives comprehensive literacy/num sensitive diabetes care

Interventions

Literacy/Numeracy oriented educational intervention

Receives comprehensive literacy/num sensitive diabetes care

Intervention Type: BEHAVIORAL

Control Group

Receives standard diabetes disease management

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

American Diabetes Association

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Vanderbilt University

Principal Investigators

Robb Malone, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Russell L Rothman, MD MPP

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

University of North Carolina at Chapel Hill, General Medicine Clinic

Chapel Hill, North Carolina, United States

Countries

United States

References

Cavanaugh K, Wallston KA, Gebretsadik T, Shintani A, Huizinga MM, Davis D, Gregory RP, Malone R, Pignone M, DeWalt D, Elasy TA, Rothman RL. Addressing literacy and numeracy to improve diabetes care: two randomized controlled trials. Diabetes Care. 2009 Dec;32(12):2149-55. doi: 10.2337/dc09-0563. Epub 2009 Sep 9.

Reference Type: DERIVED

PMID: 19741187 (View on PubMed)

Other Identifiers

Vanderbilt IRB: 040387

Identifier Type: -

Identifier Source: secondary_id

UNC IRB: 06-0535

Identifier Type: -

Identifier Source: secondary_id

7-04-NN-16 (ADA)

Identifier Type: -

Identifier Source: org_study_id