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Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Primary Purpose

Diabetes, Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diabetes Education
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring Diabetes, Diabetes Education, Diabetic Retinopathy, HbA1c

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University Health Care, Dept. of Ophthalmology
  • California Retina Consultants
  • Retina Vitreous Consultants
  • University of Florida College of Med., Department of Ophthalmology
  • Central Florida Retina Institute
  • University of Illinois at Chicago Medical Center
  • Raj K. Maturi, M.D., P.C.
  • John-Kenyon American Eye Institute
  • Retina and Vitreous Associates of Kentucky
  • Paducah Retinal Center
  • Elman Retina Group, P.A.
  • Wilmer Ophthalmological Institute at Johns Hopkins
  • Joslin Diabetes Center
  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
  • Retina Center, PA
  • Barnes Retina Institute
  • The New York Eye and Ear Infirmary/Faculty Eye Practice
  • University of North Carolina, Dept of Ophthalmology
  • Charlotte Eye, Ear, Nose and Throat Assoc., PA
  • Wake Forest University Eye Center
  • Retina Associates of Cleveland, Inc.
  • Case Western Reserve University
  • Casey Eye Institute
  • Penn State College of Medicine
  • University of Pennsylvania Scheie Eye Institute
  • Palmetto Retina Center
  • Carolina Retina Center
  • Retina Research Center
  • Retina and Vitreous of Texas
  • Valley Retina Institute
  • Retinal Consultants of San Antonio
  • University of Washington Medical Center
  • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes Educational Intervention

Standard Care

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 24, 2011
Last Updated
August 25, 2016
Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01323348
Brief Title
Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control
Official Title
Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Retinopathy
Keywords
Diabetes, Diabetes Education, Diabetic Retinopathy, HbA1c

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1875 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Educational Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Education
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
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
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Diabetes Care Knowledge
Description
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.
Time Frame
12 Months/24 Months
Title
Blood Pressure
Description
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.
Time Frame
12 Months/24 Months
Title
Body Mass Index
Description
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.
Time Frame
12 Months/24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lloyd P Aiello, M.D.
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University Health Care, Dept. of Ophthalmology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Retina Vitreous Consultants
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
University of Florida College of Med., Department of Ophthalmology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Central Florida Retina Institute
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
University of Illinois at Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Raj K. Maturi, M.D., P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
John-Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Retina and Vitreous Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509-1802
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Elman Retina Group, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Wilmer Ophthalmological Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9277
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Retina Center, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Barnes Retina Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The New York Eye and Ear Infirmary/Faculty Eye Practice
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of North Carolina, Dept of Ophthalmology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7040
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Assoc., PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Wake Forest University Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Palmetto Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Carolina Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29223
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina and Vitreous of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25996273
Citation
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.
Results Reference
result
Links:
URL
http://www.drcr.net
Description
Related Info

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Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

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