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Sponsors and Collaborators: |
Vanderbilt University Pfizer Vanderbilt DRTC P&F Grant (DK20593) American Diabetes Association |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00311922 |
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.
Condition | Intervention |
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Diabetes |
Behavioral: Literacy/Numeracy oriented educational intervention Behavioral: Control Group |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Improving Care for Patients With Diabetes and Poor Numeracy Skills |
Enrollment: | 106 |
Study Start Date: | March 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Active Comparator
Active Control Arm receives Comprehensive Diabetes Education
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Behavioral: Control Group
Receives comprehensive education that is not literacy/numeracy sensitive
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Intervention Arm: Experimental
Receives comprehensive education that is literacy/numeracy sensitive
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Behavioral: Literacy/Numeracy oriented educational intervention
Comprehensive educational Intervention
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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 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Russell L Rothman, MD MPP | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Russell Rothman ) |
Study ID Numbers: | IRB# 060128, DK20593 P&F 6 NIH/NIDDK |
Study First Received: | April 4, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00311922 History of Changes |
Health Authority: | United States: Institutional Review Board |
Diabetes Education Health Literacy |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |