- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00649766
Tailored Messages to Increase Eye Examination Behavior
March 28, 2008 updated by: National Eye Institute (NEI)
The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined.
We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Studies have shown that people are not getting their eyes examined on a regular basis, even though dilated eye exams can detect eye diseases like glaucoma and diabetic retinopathy early, before significant vision loss has developed.
Early detection can lead to earlier treatment, which can save sight by preventing or slowing the progression of these eye diseases.
In this project we designed, implemented, and are now evaluating tailored and targeted print health messages to increase eye examination behavior in an African-American population 65 years of age and older, a group at increased risk of glaucoma and diabetes.
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- African-American
- 65 years of age or older
- no dilated fundus exam in past 2 years
Exclusion Criteria:
- appointment for dilated fundus exam scheduled
- no access to phone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
tailored print messages to encourage eye examination behavior
|
Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease
|
Active Comparator: 2
targeted print messages to encourage eye examination behavior
|
Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
doctor-confirmed dilated eye examination
Time Frame: 3 and 6 months
|
3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy J. Ellish, DrPH, MSPH, University of Maryland, Baltimore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ellish NJ, Royak-Schaler R, Passmore SR, Higginbotham EJ. Knowledge, attitudes, and beliefs about dilated eye examinations among African-Americans. Invest Ophthalmol Vis Sci. 2007 May;48(5):1989-94. doi: 10.1167/iovs.06-0934.
- Ellish NJ, Royak-Schaler R, Higginbotham EJ. Tailored and targeted interventions to encourage dilated fundus examinations in older African Americans. Arch Ophthalmol. 2011 Dec;129(12):1592-8. doi: 10.1001/archophthalmol.2011.190.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Anticipated)
May 1, 2008
Study Completion (Anticipated)
May 1, 2008
Study Registration Dates
First Submitted
March 28, 2008
First Submitted That Met QC Criteria
March 28, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 28, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01EY015899 (U.S. NIH Grant/Contract)
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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