Clinical trial NCT00469105: Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Official title: Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Diabetes Education
Health Literacy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: American Diabetes Association
name: Pfizer
First posted: 2007-05-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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.

Primary outcomes:
measure: A1C
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Patient self-management behaviors
timeFrame: 3 and 6 months
measure: Patient knowledge
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, General Medicine Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Robb Malone, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Russell L Rothman, MD MPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.