Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control
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| ClinicalTrials.gov Identifier: NCT01323348 |
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Recruitment Status :
Completed
First Posted : March 25, 2011
Last Update Posted : August 26, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Diabetic Retinopathy | Behavioral: Diabetes Education | Phase 3 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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):
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No Intervention: Standard Care
Usual care
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- 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
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323348
Show 34 study locations
| Study Chair: | Lloyd P Aiello, M.D. | Joslin Diabetes Center |
Publications of Results:
| Responsible Party: | Jaeb Center for Health Research |
| ClinicalTrials.gov Identifier: | NCT01323348 |
| Other Study ID Numbers: |
DRCR.net-Protocol M |
| First Posted: | March 25, 2011 Key Record Dates |
| Last Update Posted: | August 26, 2016 |
| Last Verified: | August 2016 |
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Diabetes Diabetes Education Diabetic Retinopathy HbA1c |
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Retinal Diseases Diabetic Retinopathy Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications |