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Sponsors and Collaborators: |
Vanderbilt University University of North Carolina American Diabetes Association Pfizer |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00469105 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Behavioral: Literacy/Numeracy oriented educational intervention Behavioral: Control Group |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills |
Estimated Enrollment: | 110 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Control: Active Comparator
Control Arm receives standard diabetes disease management
|
Behavioral: Control Group
Receives standard diabetes disease management
|
Intervention Arm: Experimental
Receives numeracy/literacy sensitive diabetes management
|
Behavioral: Literacy/Numeracy oriented educational intervention
Receives comprehensive literacy/num sensitive diabetes care
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
University of North Carolina at Chapel Hill, General Medicine Clinic | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Robb Malone, PharmD | The University of North Carolina, Chapel Hill |
Principal Investigator: | Russell L Rothman, MD MPP | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Russell Rothman ) |
Study ID Numbers: | 7-04-NN-16 (ADA), Vanderbilt IRB: 040387, UNC IRB: 06-0535 |
Study First Received: | May 3, 2007 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00469105 |
Health Authority: | United States: Institutional Review Board |
Type 2 Diabetes Diabetes Education Health Literacy |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |