- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417924
Eye on Diabetes: A Multidisciplinary Patient Education Intervention
Eye Health and Vision Care for Patients With Diabetes: Comparing Usual Care to a Targeted Intervention in a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients with diabetes may not understand the importance of annual dilated eye examinations or recognize the benefits of early detection of diabetic eye disease. The goal of this study is to compare the efficacy of usual care to an intervention emphasizing patient education targeted at a multicultural adult patient population with diabetes seeking eye care in an academic health center. The specific aims of this study are to evaluate patient knowledge of preventive health strategies for diabetes as they pertain to eye health and vision care, to assess patient satisfaction with eye and vision care, and to promote interdisciplinary collaboration in the care of patients with diabetes.
Ninety patients were randomized to two arms representing usual care and an intervention emphasizing patient education targeted at English-speaking adults with diabetes seeking eye care in an academic health center. The project was developed within the Health Professions Division at Nova Southeastern University.
Participation was comprised of a comprehensive eye health and vision examination, patient education, and completion of study instruments described below. A demographic survey documenting patient age, sex, physician-reported HbA1C, education, and birthplace was administered to all patients at baseline. Race and ethnicity were self reported using categories in current use by the National Eye Institute, National Institutes of Health (Bethesda, MD).
Patients assigned to the intervention were provided with a written report at the conclusion of the examination. The triplicate form included a report of eye examination findings with a copy designated for the medical record, the primary care physician, and the patient. The back side of the patient's copy included educational materials targeted at a layperson while the physician's copy included information directed at a primary health care provider.
Patients assigned to usual care received patient education at the discretion of the eye care provider. Following the initial examination, all medical records were reviewed with attention to communication with other health care providers, as well as other issues related to continuity and coordination of care. Patients assigned to usual care were mailed additional written educational materials at the conclusion of the study, after all study instruments had been completed.
Patients assigned to the intervention were invited to participate in a supplementary seminar that reinforced the educational message delivered at the time of the initial examination. A multidisciplinary (optometry, pharmacy, endocrinology) patient education curriculum incorporating materials from the National Eye Health Education Program (NEHEP) Diabetic Eye Disease Public Education Program, the "ABC's of diabetes", an interactive activity, and a question and answer session was developed for patients randomized to the intervention.
Study Type
Enrollment
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Florida
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Ft. Lauderdale, Florida, United States, 33328
- Sanford L. Ziff Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients with Type I or Type II Diabetes
- English speaking
Exclusion Criteria:
- Visual acuity worse than 20/60
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Patient knowledge (pre-test, post-test, and 3 month post-test)
|
Patient satisfaction post-examination
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heidi Wagner, OD, MPH, Nova Southeastern University, Health Professions Division
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPT06170409X
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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