Improving Care for Patients With Diabetes and Poor Numeracy Skills
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Purpose
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 |
|---|---|
|
Diabetes |
Behavioral: Literacy/Numeracy oriented educational intervention Behavioral: Control Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Care for Patients With Diabetes and Poor Numeracy Skills |
- A1C [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- Patient self-management behaviors [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- Patient knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Russell L Rothman, MD MPP | Vanderbilt University |
More Information
No publications provided by Vanderbilt University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Russell Rothman, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00311922 History of Changes |
| Other Study ID Numbers: | IRB# 060128, DK20593 P&F 6 NIH/NIDDK |
| Study First Received: | April 4, 2006 |
| Last Updated: | February 15, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Diabetes Education Health Literacy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013