Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Diabetes Clinical Trial

Official title:

Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323348
• Other study ID #: DRCR.net-Protocol M
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: August 25, 2016
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: August 2016
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1875
• Est. completion date: January 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Retina Research Center	Austin	Texas
United States	Elman Retina Group, P.A.	Baltimore	Maryland
United States	Wilmer Ophthalmological Institute at Johns Hopkins	Baltimore	Maryland
United States	Retina Associates of Cleveland, Inc.	Beachwood	Ohio
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of North Carolina, Dept of Ophthalmology	Chapel Hill	North Carolina
United States	Charlotte Eye, Ear, Nose and Throat Assoc., PA	Charlotte	North Carolina
United States	University of Illinois at Chicago Medical Center	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Carolina Retina Center	Columbia	South Carolina
United States	Palmetto Retina Center	Columbia	South Carolina
United States	Henry Ford Health System, Dept of Ophthalmology and Eye Care Services	Detroit	Michigan
United States	Retina Vitreous Consultants	Ft. Lauderdale	Florida
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	Retina and Vitreous of Texas	Houston	Texas
United States	Raj K. Maturi, M.D., P.C.	Indianapolis	Indiana
United States	University of Florida College of Med., Department of Ophthalmology	Jacksonville	Florida
United States	Central Florida Retina Institute	Lakeland	Florida
United States	Retina and Vitreous Associates of Kentucky	Lexington	Kentucky
United States	Loma Linda University Health Care, Dept. of Ophthalmology	Loma Linda	California
United States	University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service	Madison	Wisconsin
United States	Valley Retina Institute	McAllen	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Retina Center, PA	Minneapolis	Minnesota
United States	John-Kenyon American Eye Institute	New Albany	Indiana
United States	The New York Eye and Ear Infirmary/Faculty Eye Practice	New York	New York
United States	Paducah Retinal Center	Paducah	Kentucky
United States	University of Pennsylvania Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Casey Eye Institute	Portland	Oregon
United States	Retinal Consultants of San Antonio	San Antonio	Texas
United States	California Retina Consultants	Santa Barbara	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Barnes Retina Institute	St. Louis	Missouri
United States	Wake Forest University Eye Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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