Socially Assistive Robots to Enhance Magnification Device Use for Reading

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Vision
• Intervention / Treatment: Behavioral: Socially Assistive Robot for Low Vision Rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ava K Bittner, OD, PhD; Phone Number: 310-206-4649; Email: abittner@mednet.ucla.edu
• Study Contact Backup: Name: Andrea Obligacion; Phone Number: 310-206-9566; Email: AObligacion@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Stein Eye Institute
      • Contact: Ava K Bittner, OD, PhD; Phone Number: 310-206-4649
      • Principal Investigator: Ava K Bittner, OD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Robot; One month after study entry, participants will receive the robot at home for two months, followed by a three month observation period without the robot.	Behavioral: Socially Assistive Robot for Low Vision Rehabilitation; A socially assistive robot will be customized to engage in dialog and conversations to motivate and encourage optimal use of new magnification devices for reading at home by individuals with vision loss.
Active Comparator: Delayed/Waitlist Robot; Three months after study entry, participants will receive the robot at home for three months.	Behavioral: Socially Assistive Robot for Low Vision Rehabilitation; A socially assistive robot will be customized to engage in dialog and conversations to motivate and encourage optimal use of new magnification devices for reading at home by individuals with vision loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Inventory	questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)	change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MNread	reading test	For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.
Sustained Silent Reading Test	reading test	baseline and monthly for 6 months
Geriatric Depression Scale (GDS)	questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression	baseline and monthly for 6 months
PANAS	questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods	baseline and monthly for 6 months
Perceived Stress Scale	questionnaire; scale ranges from 0 to 56 with higher values indicating greater perceived stress	baseline and monthly for 6 months
3-item UCLA Loneliness Scale	questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness	baseline and monthly for 6 months
Duke Social Support Index	questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support	baseline and monthly for 6 months
Almere	questionnaire; scale ranges from 41 to 205 with higher values indicating greater acceptance of robots	1 month post-enrollment and 2-3 months after receiving the socially assistive robot

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Ava K Bittner, OD, PhD, UCLA Stein Eye Institute; Vision Rehabilitation Center; Principal Investigator: Maja J Mataric, PhD, USC Interaction Lab; Viterbi School of Engineering

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: robot
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Vision, Low
• Other Study ID Numbers: 19-001429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No