Improving Care for Patients With Diabetes and Poor Numeracy Skills
2 other identifiers
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Mar 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 4, 2006
CompletedFirst Posted
Study publicly available on registry
April 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 18, 2008
February 1, 2008
1.8 years
April 4, 2006
February 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A1C
3 and 6 months
Secondary Outcomes (3)
Patient self-management behaviors
3 and 6 months
Patient knowledge
6 months
Patient satisfaction
6 months
Study Arms (2)
Control
ACTIVE COMPARATORActive Control Arm receives Comprehensive Diabetes Education
Intervention Arm
EXPERIMENTALReceives comprehensive education that is literacy/numeracy sensitive
Interventions
Comprehensive educational Intervention
Receives comprehensive education that is not literacy/numeracy sensitive
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Type 1 or 2 Diabetes;
- most recent A1C greater than or equal to 7.0%;
- Referred to the Diabetes Improvement Program for diabetes care;
- Age 18-80;
- English Speaking.
You may not qualify if:
- Patients with corrected visual Acuity \>20/50 using a Rosenbaum Pocket Vision Screener, or
- Patients with a diagnosis of significant dementia, psychosis, or blindness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- Pfizercollaborator
- Vanderbilt DRTC P&F Grant (DK20593)collaborator
- American Diabetes Associationcollaborator
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
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.
PMID: 19741187DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Russell L Rothman, MD MPP
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 4, 2006
First Posted
April 6, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 18, 2008
Record last verified: 2008-02