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Clinical Trials/NCT04190134
NCT04190134
Recruiting
Phase 1

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

University of California, Los Angeles1 site in 1 country20 target enrollmentApril 22, 2022
ConditionsLow Vision

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Low Vision
Sponsor
University of California, Los Angeles
Enrollment
20
Locations
1
Primary Endpoint
Activity Inventory
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2022
End Date
February 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ava K. Bittner, OD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Activity Inventory

Time Frame: 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)

Secondary Outcomes

  • 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)

Study Sites (1)

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