Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control
1 other identifier
interventional
1,875
1 country
34
Brief Summary
The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes
Started Oct 2011
Longer than P75 for phase_3 diabetes
34 active sites
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
First Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedAugust 26, 2016
August 1, 2016
2.8 years
March 24, 2011
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care more frequently than every 12 months
12 Months
Secondary Outcomes (3)
Diabetes Care Knowledge
12 Months/24 Months
Blood Pressure
12 Months/24 Months
Body Mass Index
12 Months/24 Months
Study Arms (2)
Diabetes Educational Intervention
EXPERIMENTALStudy participants in the intervention group will receive a diabetes management educational intervention at baseline and at follow-up visits. For those on an annual follow-up schedule, educational intervention will take place at baseline and 12 months. For those whose standard care involves more frequent, than annual, visits the educational intervention will take place no more than once every 12 weeks.
Standard Care
NO INTERVENTIONUsual care
Interventions
The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks): * Measurement of HbA1c in office with immediate feedback * Measurement of blood pressure with immediate feedback * Assessment of retinopathy risk with immediate feedback * Personalized risk assessment reports based on current HbA1c * Brief assessment of patient understanding of key issues with immediate feedback * Supplemental diabetes management educational materials (provided at baseline only) * Feedback to primary care provider * Email reminder to study participants with email access of individualized risk assessment findings
Eligibility Criteria
You may qualify if:
- Age \>18 years
- Diagnosis of type 1 or type 2 diabetes mellitus
- Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
- Documented diabetes by American Diabetes Associate and/or World Health Organization criteria
- Routine care follow-up is yearly or more frequent
- English or Spanish speaking
- Able and willing to provide informed consent
- Willing to complete 24 months of study follow up
You may not qualify if:
- Known HbA1c (patient report or available records at time of enrollment) \<7.5% within prior 6 months
- Active participation in any type of intervention study
- Initiation of insulin treatment within 3 months from date of enrollment
- Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in both eyes
- Advanced visual acuity loss in both eyes which prohibits ability to read study materials (tested as needed with reading test using materials in appropriate size script)
- Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or a history of chronic renal failure requiring dialysis or kidney transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Retina Vitreous Consultants
Fort Lauderdale, Florida, 33334, United States
University of Florida College of Med., Department of Ophthalmology
Jacksonville, Florida, 32209, United States
Central Florida Retina Institute
Lakeland, Florida, 33805, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46280, United States
John-Kenyon American Eye Institute
New Albany, Indiana, 47150, United States
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky, 40509-1802, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Elman Retina Group, P.A.
Baltimore, Maryland, 21237, United States
Wilmer Ophthalmological Institute at Johns Hopkins
Baltimore, Maryland, 21287-9277, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan, 48202, United States
Retina Center, PA
Minneapolis, Minnesota, 55404, United States
Barnes Retina Institute
St Louis, Missouri, 63110, United States
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York, 10003, United States
University of North Carolina, Dept of Ophthalmology
Chapel Hill, North Carolina, 27599-7040, United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina, 28210, United States
Wake Forest University Eye Center
Winston-Salem, North Carolina, 27157, United States
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, 44122, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Palmetto Retina Center
Columbia, South Carolina, 29169, United States
Carolina Retina Center
Columbia, South Carolina, 29223, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina and Vitreous of Texas
Houston, Texas, 77025, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Aiello LP, Ayala AR, Antoszyk AN, Arnold-Bush B, Baker C, Bressler NM, Elman MJ, Glassman AR, Jampol LM, Melia M, Nielsen J, Wolpert HA; Diabetic Retinopathy Clinical Research Network. Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Aug;133(8):888-96. doi: 10.1001/jamaophthalmol.2015.1312.
PMID: 25996273RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lloyd P Aiello, M.D.
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 25, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2014
Study Completion
January 1, 2015
Last Updated
August 26, 2016
Record last verified: 2016-08