跳至主要内容
临床试验/NCT04328207
NCT04328207已完成不适用

Using Telemedicine to Prevent Blindness in an At-risk Rural Alabama Population

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
2
主要终点
Percentage of Participants That Adhere to Referral Appointment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigators are masked as to which group the patient is in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Percentage of Participants That Adhere to Referral Appointment

时间窗: The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date.

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.

Percentage of Participants That Adhere to Referral Appointment

时间窗: The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Owsley

Professor

University of Alabama at Birmingham

研究点 (2)

Loading locations...

相似试验