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临床试验/NCT06107881
NCT06107881招募中不适用

Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision

University of California, Los Angeles18 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年12月15日最近更新:
适应症

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

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

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

Ava K. Bittner, OD, PhD

Associate Professor of Ophthalmology

University of California, Los Angeles

研究点 (18)

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