Eye DiseaseNCT00649766
Tailored Messages to Increase Eye Examination Behavior
A study testing tailored newsletter and targeted newsletter in people with Eye Disease and Eye Care, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Disease, Eye Care
- What is being tested?
- tailored newsletter and targeted newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- African-American
- 65 years of age or older
- no dilated fundus exam in past 2 years
Who cannot join
- appointment for dilated fundus exam scheduled
- no access to phone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
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.
Read the 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.
- Conditions
- Eye Disease, Eye Care
- Being tested
- tailored newsletter, targeted newsletter
- Keywords
- tailored health messages, glaucoma, diabetic retinopathy, dilated fundus exams, health behavior
- Medical subject headings
- Eye Diseases, Glaucoma, Diabetic Retinopathy, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored newsletterBehavioural
Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease
targeted newsletterBehavioural
Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | tailored print messages to encourage eye examination behavior Receives: Behavioral: tailored newsletter |
| 2 | Active comparator | targeted print messages to encourage eye examination behavior Receives: Behavioral: targeted newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
doctor-confirmed dilated eye examination
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2008 (estimated)
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Nancy J. Ellish, DrPH, MSPH, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649766
- Sponsor's protocol ID
- R01EY015899
- Other IDs
- R01EY015899
- Status last verified
- Mar 2008
- First submitted
- 28 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17460251Ellish 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.
PubMed 22159679
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Messages to Increase Eye Examination Behavior
- ClinicalTrials.gov ID
- NCT00649766
- Acronym / sponsor ID
- R01EY015899
- Conditions
- Eye Disease, Eye Care
- Keywords
- tailored health messages, glaucoma, diabetic retinopathy, dilated fundus exams, health behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2008 (estimated)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: tailored newslettertailored print messages to encourage eye examination behavior |
| 2 | Active comparator | Behavioral: targeted newslettertargeted print messages to encourage eye examination behavior |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- African-American
- 65 years of age or older
- no dilated fundus exam in past 2 years
Key exclusion criteria (2 listed)
- appointment for dilated fundus exam scheduled
- no access to phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tailored newsletterTailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease | Behavioural | 1 |
| targeted newsletterTargeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans. | Behavioural | 2 |
Primary outcome
doctor-confirmed dilated eye examination
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
- Results publication: PubMed 17460251Ellish 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.
- Derived from this study: PubMed 22159679Ellish 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy J. Ellish, DrPH, MSPH principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tailored newsletter and targeted newsletter in people with Eye Disease and Eye Care, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
doctor-confirmed dilated eye examination (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00649766, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.