Improving Care for Patients With Diabetes and Poor Numeracy Skills

February 15, 2008 updated by: Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Active Control Arm receives Comprehensive Diabetes Education
Behavioral: Control Group
Receives comprehensive education that is not literacy/numeracy sensitive
Experimental: Intervention Arm
Receives comprehensive education that is literacy/numeracy sensitive
Behavioral: Literacy/Numeracy oriented educational intervention
Comprehensive educational Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A1C
Time Frame: 3 and 6 months
3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient self-management behaviors
Time Frame: 3 and 6 months
3 and 6 months
Patient knowledge
Time Frame: 6 months
6 months
Patient satisfaction
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Pfizer
American Diabetes Association
Vanderbilt DRTC P&F Grant (DK20593)

Investigators

  • Principal Investigator: Russell L Rothman, MD MPP, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 18, 2008

Last Update Submitted That Met QC Criteria

February 15, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 060128
  • DK20593 P&F 6 NIH/NIDDK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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