Text Size

Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
American Diabetes Association
Pfizer
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00469105
First received: May 3, 2007
Last updated: April 22, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Behavioral: Literacy/Numeracy oriented educational intervention
Behavioral: Control Group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • A1C [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control Arm receives standard diabetes disease management
 Behavioral: Control Group
Receives standard diabetes disease management
Experimental: Intervention Arm
Receives numeracy/literacy sensitive diabetes management
 Behavioral: Literacy/Numeracy oriented educational intervention
Receives comprehensive literacy/num sensitive diabetes care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469105

Locations
United States, North Carolina
University of North Carolina at Chapel Hill, General Medicine Clinic
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Vanderbilt University
University of North Carolina, Chapel Hill
American Diabetes Association
Pfizer
Investigators
Principal Investigator: Robb Malone, PharmD University of North Carolina, Chapel Hill
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: NCT00469105     History of Changes
Other Study ID Numbers: 7-04-NN-16 (ADA), Vanderbilt IRB: 040387, UNC IRB: 06-0535
Study First Received: May 3, 2007
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Type 2 Diabetes
Diabetes Education
Health Literacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013