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NCT Number: NCT00311922

Improving Care for Patients With Diabetes and Poor Numeracy Skills

The aim of this research will be to perform a 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 patients with diabetes and low numeracy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, 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 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 patients with diabetes and low numeracy. We hypothesize that a group of patients with poor 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Type 1 or 2 Diabetes;
  • most recent A1C greater than or equal to 7.0%;
  • Referred to the Diabetes Improvement Program for diabetes care;
  • Age 18-80;
  • English Speaking.

Exclusion criteria

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

Treatment and study plan

Literacy/Numeracy oriented educational intervention

Behavioral

Comprehensive educational Intervention

Control Group

Behavioral

Receives comprehensive education that is not literacy/numeracy sensitive

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
  • Vanderbilt DRTC P&F Grant (DK20593)

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 6, 2006
Registry last updated
Feb 18, 2008

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.

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