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临床试验/NCT04190134
NCT04190134招募中1 期

Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
20
试验地点
2
主要终点
Activity Inventory

研究概览

简要总结

The aims of this exploratory research project are to customize, deploy and evaluate the preliminary efficacy of a socially assistive robot as a novel approach to motivate and encourage optimal, long-term use of new magnification devices for reading in individuals with vision loss. The goals are to promote patient acceptance, adherence and skills reinforcement to achieve proficiency in the use of the magnifier, in order to attempt to reduce visual disability while performing important daily activities, such as reading 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, all of which motivate the development of this complementary approach for the provision of additional support at home by the socially assistive robot.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Individuals with any level of vision loss due to any ocular disease,
  • age 18 and older,
  • received a magnification device(s) (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and CCTVs) from the UCLA Vision Rehabilitation Center.

排除标准

  • schedules not permitting participation in planned study sessions or visits (including planning to move or take extended vacation during study period),
  • inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment as per TICS),
  • substance abuse,
  • significant hearing loss (unable to hear communication by phone or from robot),
  • significant medical condition likely to limit participation or lifespan,
  • 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), and/or (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device.

结局指标

主要结局

Activity Inventory

时间窗: change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot

questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

次要结局

  • Duke Social Support Index(baseline and monthly for 6 months)
  • Perceived Stress Scale(baseline and monthly for 6 months)
  • Sustained Silent Reading Test(baseline and monthly for 6 months)
  • Geriatric Depression Scale (GDS)(baseline and monthly for 6 months)
  • 3-item UCLA Loneliness Scale(baseline and monthly for 6 months)
  • MNread(For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.)
  • PANAS(baseline and monthly for 6 months)
  • Almere(1 month post-enrollment and 2-3 months after receiving the socially assistive robot)

研究者

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

Ava K. Bittner, OD, PhD

Principal Investigator

University of California, Los Angeles

研究点 (2)

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