Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
NCT00469105
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1. Clinical diagnosis of Type 2 Diabetes
2. most recent A1C >= 7.5%
3. Referred to the Diabetes Care Program for diabetes care
4. Age 18-85; 5. English Speaking.
1. Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener
2. Patients with a diagnosis of significant dementia, psychosis, or blindness.
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Descriptive Information | |||||||
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Brief Title ICMJE | Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills | ||||||
Official Title ICMJE | Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills | ||||||
Brief Summary | 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. | ||||||
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 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | ||||||
Condition ICMJE | Type 2 Diabetes | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Cavanaugh K, Wallston KA, Gebretsadik T, Shintani A, Huizinga MM, Davis D, Gregory RP, Malone R, Pignone M, DeWalt D, Elasy TA, Rothman RL. Addressing literacy and numeracy to improve diabetes care: two randomized controlled trials. Diabetes Care. 2009 Dec;32(12):2149-55. doi: 10.2337/dc09-0563. Epub 2009 Sep 9. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Estimated Enrollment ICMJE | 110 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | March 2008 | ||||||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00469105 | ||||||
Other Study ID Numbers ICMJE | 7-04-NN-16 (ADA) Vanderbilt IRB: 040387 UNC IRB: 06-0535 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Russell Rothman, Vanderbilt University | ||||||
Study Sponsor ICMJE | Vanderbilt University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Vanderbilt University | ||||||
Verification Date | April 2010 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |