Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
3 other identifiers
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Dec 2006
Shorter than P25 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 3, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 23, 2010
April 1, 2010
1.2 years
May 3, 2007
April 22, 2010
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 COMPARATORControl Arm receives standard diabetes disease management
Intervention Arm
EXPERIMENTALReceives numeracy/literacy sensitive diabetes management
Interventions
Receives comprehensive literacy/num sensitive diabetes care
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Type 2 Diabetes
- most recent A1C \>= 7.5%
- Referred to the Diabetes Care Program for diabetes care
- Age 18-85; 5. English Speaking.
You may not qualify if:
- Patients with corrected visual Acuity \>20/50 using a Rosenbaum Pocket Vision Screener
- Patients with a diagnosis of significant dementia, psychosis, or blindness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- University of North Carolina, Chapel Hillcollaborator
- American Diabetes Associationcollaborator
- Pfizercollaborator
Study Sites (1)
University of North Carolina at Chapel Hill, General Medicine Clinic
Chapel Hill, North Carolina, 27599, 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
Robb Malone, PharmD
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Russell L Rothman, MD MPP
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 3, 2007
First Posted
May 4, 2007
Study Start
December 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 23, 2010
Record last verified: 2010-04