Improving Care for Patients With Diabetes and Poor Numeracy Skills

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Vanderbilt DRTC P&F Grant (DK20593)
American Diabetes Association
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00311922
First received: April 4, 2006
Last updated: February 15, 2008
Last verified: February 2008
  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

Resource links provided by NLM:


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 ]

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 April 17, 2014