NCT00417924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2004

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

January 4, 2007

Status Verified

December 1, 2006

First QC Date

January 2, 2007

Last Update Submit

January 2, 2007

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Patient educationPatient satisfactionEye health

Outcome Measures

Primary Outcomes (2)

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

  • Patient satisfaction post-examination

Interventions

Patient educationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Visual acuity worse than 20/60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford L. Ziff Health Center

Fort Lauderdale, Florida, 33328, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Patient Satisfaction

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Heidi Wagner, OD, MPH

    Nova Southeastern University, Health Professions Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

October 1, 2004

Study Completion

October 1, 2005

Last Updated

January 4, 2007

Record last verified: 2006-12

Locations

US(1)