Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417924
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2007-01-02
Brief Title:
Eye on Diabetes A Multidisciplinary Patient Education Intervention
Sponsor:
Nova Southeastern University
Organization:
Nova Southeastern University
Study Overview
Official Title:
Eye Health and Vision Care for Patients With Diabetes Comparing Usual Care to a Targeted Intervention in a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients copy included educational materials targeted at a layperson while the physicians 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 ABCs of diabetes an interactive activity and a question and answer session was developed for patients randomized to the intervention
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 patients copy included educational materials targeted at a layperson while the physicians 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 ABCs of diabetes an interactive activity and a question and answer session was developed for patients randomized to the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None