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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DP006441-01-00 | Other Identifier | Centers for Disease Control | |
| 1U01DP006441-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No financial incentive | Other | This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Financial Incentive | Other | Standard of care eye health education |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A Girkin, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33492893 | Derived | 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. |
| Label | URL |
|---|---|
| Website describing the research program as well as two other research programs funded by the same mechanism. | View source |
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To be determined at a later point.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Financial Incentive | This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit. No Financial Incentive: Standard of care eye health education |
| FG001 | Financial Incentive | This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education. Financial Incentive: Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Financial Incentive | This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit. No Financial Incentive: Standard of care eye health education |
| BG001 | Financial Incentive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | From electronic medical record |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date. |
|
24 months
The definition of an adverse event is as defined by clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Financial Incentive | This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit. No Financial Incentive: Standard of care eye health education |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Owsley | University of Alabama at Birmingham | 2053258635 | cynthiaowsley@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2025 | Jul 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D003930 | Diabetic Retinopathy |
| D012030 | Refractive Errors |
| D002386 | Cataract |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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The investigators are masked as to which group the patient is in.
| Financial Incentive | Behavioral | Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed. |
|
This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education. Financial Incentive: Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Financial Incentive |
This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education. Financial Incentive: Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed. |
|
|
| 0 |
| 499 |
| 0 |
| 499 |
| 0 |
| 499 |
| EG001 | Financial Incentive | This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education. Financial Incentive: Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed. | 0 | 401 | 0 | 401 | 0 | 401 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007905 | Lens Diseases |
| D001519 | Behavior |