Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Sponsor

Jaeb Center for Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT01323348

Collaborator

National Eye Institute (NEI) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

1,875

Enrollment

Locations

Arms

Duration (Months)

55.1

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetic Retinopathy	Behavioral: Diabetes Education	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1875 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Standard Care Usual care

Arm

Intervention/Treatment

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

No Intervention: Standard Care

Usual care

Outcome Measures

Primary Outcome Measures

Change in HbA1c [12 Months]
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 [12 Months/24 Months]
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 [12 Months/24 Months]
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 [12 Months/24 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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