Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier:
NCT01323348
First received: March 24, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Diabetes
Diabetic Retinopathy
Behavioral: Diabetes Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Resource links provided by NLM:


Further study details as provided by Diabetic Retinopathy Clinical Research Network:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months/24 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: October 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323348

  Show 34 Study Locations
Sponsors and Collaborators
Diabetic Retinopathy Clinical Research Network
Investigators
Study Chair: Lloyd P Aiello, M.D. Joslin Diabetes Center
  More Information

Additional Information:
No publications provided

Responsible Party: Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier: NCT01323348     History of Changes
Other Study ID Numbers: DRCR.net-Protocol M
Study First Received: March 24, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetic Retinopathy Clinical Research Network:
Diabetes
Diabetes Education
Diabetic Retinopathy
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Complications
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014