Clinical trial NCT01323348: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetic Retinopathy
Keywords: Diabetes
Diabetes Education
Diabetic Retinopathy
HbA1c
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-03-25
Enrollment: 1875
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 12 Months
Secondary outcomes:
measure: Diabetes Care Knowledge
timeFrame: 12 Months/24 Months
measure: Blood Pressure
timeFrame: 12 Months/24 Months
measure: Body Mass Index
timeFrame: 12 Months/24 Months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health Care, Dept. of Ophthalmology
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Ft. Lauderdale
country: United States
facility: Retina Vitreous Consultants
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Med., Department of Ophthalmology
state: Florida
city: Lakeland
country: United States
facility: Central Florida Retina Institute
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, M.D., P.C.
state: Indiana
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Retina and Vitreous Associates of Kentucky
state: Kentucky
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Baltimore
country: United States
facility: Elman Retina Group, P.A.
state: Maryland
city: Baltimore
country: United States
facility: Wilmer Ophthalmological Institute at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center, PA
state: Minnesota
city: St. Louis
country: United States
facility: Barnes Retina Institute
state: Missouri
city: New York
country: United States
facility: The New York Eye and Ear Infirmary/Faculty Eye Practice
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Dept of Ophthalmology
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Assoc., PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Eye Center
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Scheie Eye Institute
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Columbia
country: United States
facility: Carolina Retina Center
state: South Carolina
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Houston
country: United States
facility: Retina and Vitreous of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Joslin Diabetes Center
name: Lloyd P Aiello, M.D.
role: STUDY_CHAIR
References:
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.