Clinical trial NCT00311922: Improving Care for Patients With Diabetes and Poor Numeracy Skills
Official title: Improving Care for Patients With Diabetes and Poor Numeracy Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Education
Health Literacy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Vanderbilt DRTC P&F Grant (DK20593)
name: American Diabetes Association
First posted: 2006-04-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

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: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
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.