Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Retinopathy
• Intervention / Treatment: Behavioral: Diabetes Education

Detailed Description

Although each patient with diabetes should be receiving diabetic education as part of their on-going routine medical care, it is likely that such education is delivered with different details and intensity. Motivating a patient with diabetes to become involved in his or her care is of primary importance in achieving better systemic control.

Ocular complications from diabetes remain the most common cause of blindness among American adults 20-74 years of age. A recent survey reported that loss of vision is the most feared of all diabetic complications. Thus, it is possible that an educational intervention at an ophthalmology office may have additional impact beyond the current standard of diabetes education at a primary care or diabetologist/endocrinologist office alone. This study will determine whether diabetes education in the ophthalmology office (which includes same-visit feedback of HbA1c levels, combined with standardized education regarding same-visit blood pressure, retinopathy status and overall diabetes education) can improve subsequent HbA1c as compared with current standard care in an ophthalmology office.

Materials used in this research setting must be applicable for use in ophthalmology practices. Therefore, the materials and procedures for this study have been developed with the goal of easy translation to this audience.

• Study Type: Interventional
• Enrollment (Actual): 1875
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health Care, Dept. of Ophthalmology
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Florida
    • Ft. Lauderdale, Florida, United States, 33334
      • Retina Vitreous Consultants
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Med., Department of Ophthalmology
    • Lakeland, Florida, United States, 33805
      • Central Florida Retina Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46280
      • Raj K. Maturi, M.D., P.C.
    • New Albany, Indiana, United States, 47150
      • John-Kenyon American Eye Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40509-1802
      • Retina and Vitreous Associates of Kentucky
    • Paducah, Kentucky, United States, 42001
      • Paducah Retinal Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Elman Retina Group, P.A.
    • Baltimore, Maryland, United States, 21287-9277
      • Wilmer Ophthalmological Institute at Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Retina Center, PA
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Barnes Retina Institute
  • New York
    • New York, New York, United States, 10003
      • The New York Eye and Ear Infirmary/Faculty Eye Practice
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7040
      • University of North Carolina, Dept of Ophthalmology
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, Ear, Nose and Throat Assoc., PA
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Eye Center
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Retina Associates of Cleveland, Inc.
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Scheie Eye Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29223
      • Carolina Retina Center
    • Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • Texas
    • Austin, Texas, United States, 78705
      • Retina Research Center
    • Houston, Texas, United States, 77025
      • Retina and Vitreous of Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute
    • San Antonio, Texas, United States, 78240
      • Retinal Consultants of San Antonio
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >18 years

2. 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
3. Routine care follow-up is yearly or more frequent
4. English or Spanish speaking
5. Able and willing to provide informed consent
6. Willing to complete 24 months of study follow up

Exclusion Criteria:

1. Known HbA1c (patient report or available records at time of enrollment) <7.5% within prior 6 months
2. Active participation in any type of intervention study
3. Initiation of insulin treatment within 3 months from date of enrollment
4. Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in both eyes
5. 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)
6. Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or a history of chronic renal failure requiring dialysis or kidney transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Usual care
Experimental: Diabetes Educational Intervention; Study 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.	Behavioral: Diabetes Education; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Care Knowledge	At baseline and at annual visits, study participants in all treatment groups will complete self-assessment questionnaires in order to assess perception of emotional problems frequently reported in type 1 and type 2 diabetes and to measure perceived adherence to diabetes self-care recommendations. At the annual visits, summary statistics will be presented on the responses as appropriate to the distribution and the treatment groups will be compared controlling for baseline responses.	12 Months/24 Months
Blood Pressure	For analyses, systolic and diastolic blood pressure will be converted to an overall mean blood pressure according to the following calculation: diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure). Blood pressure will be analyzed as the change in the weighted mean blood pressure from baseline to 12 months adjusted for the baseline weighted mean blood pressure. Treatment group comparisons will be made using ANCOVA to adjust for the baseline blood pressure, with GEE to adjust for the correlation within subjects of the same cluster.	12 Months/24 Months
Body Mass Index	Treatment group comparisons will be made using analysis of covariance (ANCOVA) to adjust for the baseline HbA1c, with generalized estimating equations (GEE) to adjust for the correlation within subjects of the same randomization cluster.	12 Months/24 Months

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Eye Institute (NEI)
• Investigators: Study Chair: Lloyd P Aiello, M.D., Joslin Diabetes Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes; HbA1c; Diabetic Retinopathy; Diabetes Education
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: DRCR.net-Protocol M