Eye on Diabetes: A Multidisciplinary Patient Education Intervention

• ClinicalTrials.gov Identifier: NCT00417924
• Recruitment Status: Completed
• First Posted: January 4, 2007
• Last Update Posted: January 4, 2007
• Sponsor: Nova Southeastern University
• Information provided by: Nova Southeastern University

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2	Behavioral: Patient education	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Educational/Counseling/Training
• Official Title: Eye Health and Vision Care for Patients With Diabetes: Comparing Usual Care to a Targeted Intervention in a Randomized Controlled Trial
• Study Start Date: October 2004
• Study Completion Date: October 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Visual acuity worse than 20/60

Contacts and Locations

Locations

United States, Florida

Sanford L. Ziff Health Center

Ft. Lauderdale, Florida, United States, 33328

Sponsors and Collaborators

Nova Southeastern University

Investigators

• Principal Investigator: Heidi Wagner, OD, MPH; Nova Southeastern University, Health Professions Division

More Information

• ClinicalTrials.gov Identifier: NCT00417924
• Other Study ID Numbers: OPT06170409X
• First Posted: January 4, 2007
• Last Update Posted: January 4, 2007
• Last Verified: December 2006

Keywords provided by Nova Southeastern University:

Patient education; Patient satisfaction; Eye health

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases