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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00469105
Enrollment
110
Registered
2007-05-04
Start date
2006-12-31
Completion date
2008-03-31
Last updated
2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, Diabetes Education, Health Literacy

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.

Interventions

Receives comprehensive literacy/num sensitive diabetes care

BEHAVIORALControl Group

Receives standard diabetes disease management

Sponsors

University of North Carolina, Chapel Hill
CollaboratorOTHER
American Diabetes Association
CollaboratorOTHER
Pfizer
CollaboratorINDUSTRY
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
A1C3 and 6 months

Secondary

MeasureTime frame
Patient self-management behaviors3 and 6 months
Patient knowledge6 months
Patient satisfaction6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026