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Improving Care for Patients With Diabetes and Poor Numeracy Skills

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ClinicalTrials.gov Identifier: NCT00311922
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : February 18, 2008
Sponsor:
Collaborators:
Pfizer
Vanderbilt DRTC P&F Grant (DK20593)
American Diabetes Association
Information provided by:
Vanderbilt University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Behavioral: Literacy/Numeracy oriented educational intervention Behavioral: Control Group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Care for Patients With Diabetes and Poor Numeracy Skills
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. A1C [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures :
  1. Patient self-management behaviors [ Time Frame: 3 and 6 months ]
  2. Patient knowledge [ Time Frame: 6 months ]
  3. Patient satisfaction [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of Type 1 or 2 Diabetes;
  2. most recent A1C greater than or equal to 7.0%;
  3. Referred to the Diabetes Improvement Program for diabetes care;
  4. Age 18-80;
  5. English Speaking.

Exclusion Criteria:

  1. Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or
  2. Patients with a diagnosis of significant dementia, psychosis, or blindness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311922


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Pfizer
Vanderbilt DRTC P&F Grant (DK20593)
American Diabetes Association
Investigators
Principal Investigator: Russell L Rothman, MD MPP Vanderbilt University

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
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008

Keywords provided by Vanderbilt University:
Diabetes
Education
Health Literacy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases