Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 18
- 主要终点
- Activity Inventory
研究概览
简要总结
One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults with any level of vision loss due to any ocular disease who are age 18 and older, and who have received new magnification device(s) for the first time (i.e., hand-held optical magnifiers, portable electronic video magnifiers, high near add powers of +4.00 or greater, visual assistive mobile apps for their smartphone/tablet, some stand magnifiers and CCTVs) from one of our participating low vision rehabilitation sites at the four academic centers and one private practice.
排除标准
- •schedules not permitting participation in planned study visits (including planning to move far from their clinical provider's office within the first 4-months of the study (i.e., cannot attend in-office visits) or take extended vacation that would not allow them to complete study procedures during the first four months of the study period),
- •inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (greater than mild cognitive impairment as per TICS),
- •substance abuse,
- •significant hearing loss (unable to hear communication by phone or via videoconferencing),
- •significant medical condition likely to limit participation or lifespan,
- •individuals who require other types of LVR training or intervention (e.g., psychosocial).
- •For Bluetooth low energy beacon sensors, exclusion would occur if their magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.
结局指标
主要结局
Activity Inventory
时间窗: changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device
questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
次要结局
- MNread(baseline, 1 month, 4 months, 8 months, 12 months, 13 months)
- Sustained Silent Reading Test(baseline, 1 month, 4 months, 8 months, 12 months, 13 months)
- International Reading Speed Text (IReST)(baseline, 1 month, 4 months, 8 months, 12 months, 13 months)
- Adherence to hand-held optical magnifier use (frequency and duration)(baseline to 13 months)
- Radner Reading Charts(baseline, 1 month, 4 months, 8 months, 12 months, 13 months)
- Informant surveys by close acquaintances of participants(4 months, 8 months, 12 months, 13 months)
- Vision rehabilitation satisfaction survey(after each session that will occur over a period of 1 to 8 months and and again at about 1 year)
研究者
Ava K. Bittner, OD, PhD
Associate Professor of Ophthalmology
University of California, Los Angeles