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

NCT00469105

Last updated date
Study Location
University of North Carolina at Chapel Hill, General Medicine Clinic
Chapel Hill, North Carolina, 27599, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Official Title  ICMJE Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Behavioral: Literacy/Numeracy oriented educational intervention
    Receives comprehensive literacy/num sensitive diabetes care
  • Behavioral: Control Group
    Receives standard diabetes disease management
Study Arms  ICMJE
  • Active Comparator: Control
    Control Arm receives standard diabetes disease management
    Intervention: Behavioral: Control Group
  • Experimental: Intervention Arm
    Receives numeracy/literacy sensitive diabetes management
    Intervention: Behavioral: Literacy/Numeracy oriented educational intervention
Publications * Cavanaugh K, Wallston KA, Gebretsadik T, Shintani A, Huizinga MM, Davis D, Gregory RP, Malone R, Pignone M, DeWalt D, Elasy TA, Rothman RL. Addressing literacy and numeracy to improve diabetes care: two randomized controlled trials. Diabetes Care. 2009 Dec;32(12):2149-55. doi: 10.2337/dc09-0563. Epub 2009 Sep 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 3, 2007)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00469105
Other Study ID Numbers  ICMJE 7-04-NN-16 (ADA)
Vanderbilt IRB: 040387
UNC IRB: 06-0535
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Russell Rothman, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE
  • University of North Carolina, Chapel Hill
  • American Diabetes Association
  • Pfizer
Investigators  ICMJE
Principal Investigator:Robb Malone, PharmDUniversity of North Carolina, Chapel Hill
Principal Investigator:Russell L Rothman, MD MPPVanderbilt University
PRS Account Vanderbilt University
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP