GlaucomaAL-SIGHTNCT04328207
Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits
A study testing No Financial Incentive and Financial Incentive in people with Glaucoma and Diabetic Retinopathy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Glaucoma is a blinding eye disease increasingly common in older adults, particularly in African Americans, and often diagnosed late in the disease course. It is essential to develop novel health care models, utilizing telemedicine, to improve the ability to detect glaucoma at an earlier stage, and to provide a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Diabetic Retinopathy, Refractive Errors
- What is being tested?
- No Financial Incentive and Financial Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 1 Jul 2024
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American or Hispanic ≥40 years
- Non-Hispanic white ≥50 years
- Anyone ≥ 18 years with diabetes
- Anyone ≥ 18 years with a glaucoma associated diagnosis
- Anyone ≥ 18 years with a family history of glaucoma
- All enrollees must be able to speak and understand English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Using Telemedicine to Prevent Blindness in an At-risk Rural Alabama Population
Glaucoma is a blinding eye disease increasingly common in older adults, particularly in African Americans, and often diagnosed late in the disease course. It is essential to develop novel health care models, utilizing telemedicine, to improve the ability to detect glaucoma at an earlier stage, and to provide a platform to manage this disease in community-based clinics so that further vision loss is prevented. Our goal is to improve the quality and accessibility of glaucoma detection and management among a vulnerable and at-risk segment of our population.
Read the detailed description
The number of primary open angle glaucoma (POAG) cases will increase by 250% by 2050, directly affecting over 7 million lives. These numbers are specifically for POAG and do not include the many who are monitored and treated for elevated intraocular pressure or for glaucoma suspect status, which along with POAG can all be considered glaucoma associated diseases (GAD). Development of high-quality, accessible, and cost-effective strategies for eye care for these individuals is of critical importance. POAG is at least 4-5 times higher in African Americans, progresses more rapidly and appears about 10 years earlier as compared to those of European descent. This research plan seeks to implement and evaluate a telemedicine-based detection and management strategy for GAD and other eye diseases in patients seen at Federally Qualified Health Centers (FQHC's) located in the rural Alabama Black Belt Region. This region is characterized by one of the highest concentrations of African Americans in the US; high poverty, unemployment, and uninsured rates; inadequate educational systems, transportation and community resources; few optometrists who largely practice in retail settings; and no ophthalmologists specializing in glaucoma. The investigators have developed and tested a novel multimodal telemedicine approach in a prior Centers for Disease Control and Prevention (CDC) funded Eye Care Quality and Accessibility Improvement in the Community (EQUALITY) study that used comprehensive remote optic nerve assessment (RONA). This proposal will employ a modification of the EQUALITY approach using portable measurement of visual function and optic nerve and retinal structure that are more applicable to rural locations with limited resources. The investigators will also identify and evaluate remediation strategies for the barriers to patient adherence with referral and follow-up appointments by comparing the effectiveness of financial incentives along with a validated patient education program versus a validated patient education program alone. Using this program within FQHC's will enable expansion nationwide into rural and urban underserved locations as these centers provide primary health care services in underserved areas and treat more than 27 million people yearly at over 12,000 sites.
- Conditions
- Glaucoma, Diabetic Retinopathy, Refractive Errors, Cataract, Behavior, Health
- Being tested
- No Financial Incentive, Financial Incentive
- Keywords
- telemedicine, teleophthalmology, telehealth, teleglaucoma, financial incentives
- Medical subject headings
- Glaucoma, Diabetic Retinopathy, Refractive Errors, Cataract, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Financial IncentiveOther
Also called Standard of Care
Standard of care eye health education
Financial IncentiveBehavioural
Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.
| Study group | Role | What they receive |
|---|---|---|
| No financial incentive | Other | This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit. Receives: Other: No Financial Incentive |
| Financial incentive | Experimental | This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education. Receives: Behavioral: Financial Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Adhere to Referral Appointment
The percentage of patients who adhere to attending their referral appointments who received a financial incentive and eye health education will be compared with the percentage of patients who adhere to attending their referral appointments who received standard of care eye health education alone and no financial incentive for completing a referral visit.
Measured: The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start18 Nov 2020
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In the first half of enrollment in the program there will be no financial incentive offered to any patients. In the second half of enrollment, all patients needing referral will be notified that they will receive a payment upon the completion of their referral visit.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Cynthia Owsley, University of Alabama at Birmingham
- Investigators
- Christopher A Girkin, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328207
- Sponsor's protocol ID
- IRB-300004921
- Other IDs
- 1U01DP006441-01-00, 1U01DP006441-01
- Acronym
- AL-SIGHT
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2020
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined at a later point.
Publications
Rhodes LA, Register S, Asif I, McGwin G Jr, Saaddine J, Nghiem VTH, Owsley C, Girkin CA. Alabama Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (AL-SIGHT): Study Design and Methodology. J Glaucoma. 2021 May 1;30(5):371-379. doi: 10.1097/IJG.0000000000001794.
PubMed 33492893