Skip to main content
OpenTrials
Completed

NCT Number: NCT00469105

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina at Chapel Hill, General Medicine Clinic

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Literacy/Numeracy oriented educational intervention

Behavioral

Receives comprehensive literacy/num sensitive diabetes care

Control Group

Behavioral

Receives standard diabetes disease management

Primary outcomes

  1. A1C

    Time frame: 3 and 6 months

Secondary outcomes

  1. Patient self-management behaviors

    Time frame: 3 and 6 months

  2. Patient knowledge

    Time frame: 6 months

  3. Patient satisfaction

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • American Diabetes Association
  • Pfizer
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 4, 2007
Registry last updated
Apr 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.