Eye DiseaseinChargeNCT00591110
Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
A study testing Eye care education in people with Eye Disease and Eye Care, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Disease, Eye Care, Vision
- What is being tested?
- Eye care education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2009
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African Americans ages >=60 years residing in the communities targeted for intervention or control activities
Who cannot join
- Persons who do not speak English, persons who are not community-dwelling.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older African American population. The other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. The primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. The secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.
- Conditions
- Eye Disease, Eye Care, Vision
- Being tested
- Eye care education, Social-contact control
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye care educationBehavioural
Participants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population
Social-contact controlBehavioural
Participants receive an engaging informational session on a non-health related topic
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Educational intervention communicating practical information about vision, eye conditions and eye care. Receives: Behavioral: Eye care education |
| 2 | Sham comparator | Not described Receives: Behavioral: Social-contact control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention
Measured: 6 months
Secondary outcomes (1)
Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Cynthia Owsley, University of Alabama at Birmingham
- Investigators
- Cynthia Owsley, PhD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591110
- Sponsor's protocol ID
- X060908004
- Acronym
- inCharge
- Status last verified
- Jun 2012
- First submitted
- 21 Dec 2007
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Owsley C, McGwin G Jr, Searcey K, Weston J, Johnson A, Stalvey BT, Liu B, Girkin CA. Effect of an eye health education program on older African Americans' eye care utilization and attitudes about eye care. J Natl Med Assoc. 2013 Spring;105(1):69-76. doi: 10.1016/s0027-9684(15)30087-0.
PubMed 23862298
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
- ClinicalTrials.gov ID
- NCT00591110
- Acronym / sponsor ID
- inCharge / X060908004
- Conditions
- Eye Disease, Eye Care, Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jan 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 study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older African American population. The other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. The primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. The secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Eye care educationEducational intervention communicating practical information about vision, eye conditions and eye care. |
| 2 | Sham comparator | Behavioral: Social-contact control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African Americans ages >=60 years residing in the communities targeted for intervention or control activities
Key exclusion criteria (1 listed)
- Persons who do not speak English, persons who are not community-dwelling.
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 |
|---|---|---|
| Eye care educationParticipants will receive an educational intervention communicating practical information about vision, eye conditions and eye care pertinent to the older African American population | Behavioural | 1 |
| Social-contact controlParticipants receive an engaging informational session on a non-health related topic | Behavioural | 2 |
Primary outcome
Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention
Time frame: 6 months
1 secondary outcome
Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Derived from this study: PubMed 23862298Owsley C, McGwin G Jr, Searcey K, Weston J, Johnson A, Stalvey BT, Liu B, Girkin CA. Effect of an eye health education program on older African Americans' eye care utilization and attitudes about eye care. J Natl Med Assoc. 2013 Spring;105(1):69-76. doi: 10.1016/s0027-9684(15)30087-0.
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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.
Cynthia Owsley, PhD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye care education in people with Eye Disease and Eye Care, run by University of Alabama at Birmingham 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Jun 2012. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention (time frame: 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 NCT00591110, which also lists 1 linked publication.
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 28 Jun 2012.