Improving Care for Patients With Diabetes and Poor Numeracy Skills

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Care for Patients With Diabetes and Poor Numeracy Skills

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Literacy/Numeracy oriented educational intervention
* Behavioral: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C |  | 3 and 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Education, Health Literacy