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Eye on Diabetes: A Multidisciplinary Patient Education Intervention

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Patient education
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Diabetes Mellitus, Type 1 focused on measuring Patient education, Patient satisfaction, Eye health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with Type I or Type II Diabetes
  • English speaking

Exclusion Criteria:

  • Visual acuity worse than 20/60

Sites / Locations

  • Sanford L. Ziff Health Center

Outcomes

Primary Outcome Measures

Patient knowledge (pre-test, post-test, and 3 month post-test)
Patient satisfaction post-examination

Secondary Outcome Measures

Full Information

First Posted
January 2, 2007
Last Updated
January 2, 2007
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT00417924
Brief Title
Eye on Diabetes: A Multidisciplinary Patient Education Intervention
Official Title
Eye Health and Vision Care for Patients With Diabetes: Comparing Usual Care to a Targeted Intervention in a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nova Southeastern University

4. Oversight

5. Study Description

Brief Summary
Vision loss from diabetes is often preventable with timely detection and treatment. 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 proposed research project compares usual eye care to eye care emphasizing patient education for adult patients with diabetes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
Patient education, Patient satisfaction, Eye health

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Patient education
Primary Outcome Measure Information:
Title
Patient knowledge (pre-test, post-test, and 3 month post-test)
Title
Patient satisfaction post-examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with Type I or Type II Diabetes English speaking Exclusion Criteria: Visual acuity worse than 20/60
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Wagner, OD, MPH
Organizational Affiliation
Nova Southeastern University, Health Professions Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford L. Ziff Health Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States

12. IPD Sharing Statement

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Eye on Diabetes: A Multidisciplinary Patient Education Intervention

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