Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
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 :	October 2011
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	January 2015

Arms and Interventions

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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

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Primary Outcome Measures :

1. Change in HbA1c [ Time Frame: 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 :

1. Diabetes Care Knowledge [ Time Frame: 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.
2. Blood Pressure [ Time Frame: 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.
3. Body Mass Index [ Time Frame: 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

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 34 Study Locations

Sponsors and Collaborators

Jaeb Center for Health Research

National Eye Institute (NEI)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Chair:	Lloyd P Aiello, M.D.	Joslin Diabetes Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Publications of Results:

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.

Responsible Party:	Jaeb Center for Health Research
ClinicalTrials.gov Identifier:	NCT01323348 History of Changes
Other Study ID Numbers:	DRCR.net-Protocol M
First Posted:	March 25, 2011
Last Update Posted:	August 26, 2016
Last Verified:	August 2016

Keywords provided by Jaeb Center for Health Research:

Diabetes; Diabetes Education; Diabetic Retinopathy; HbA1c

Additional relevant MeSH terms:

Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications