Socially Assistive Robots to Enhance Magnification Device Use for Reading

Low Vision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190134
• Other study ID #: 19-001429
• Status: Recruiting
• Phase: Phase 1
• Start date: April 22, 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: Ava K Bittner, OD, PhD
• Phone: 310-206-4649
• Email: abittner[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Vision
• Vision, Low

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Stein Eye Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MNread	reading test	For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.
Secondary	Sustained Silent Reading Test	reading test	baseline and monthly for 6 months
Secondary	Geriatric Depression Scale (GDS)	questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression	baseline and monthly for 6 months
Secondary	PANAS	questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods	baseline and monthly for 6 months
Secondary	Perceived Stress Scale	questionnaire; scale ranges from 0 to 56 with higher values indicating greater perceived stress	baseline and monthly for 6 months
Secondary	3-item UCLA Loneliness Scale	questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness	baseline and monthly for 6 months
Secondary	Duke Social Support Index	questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support	baseline and monthly for 6 months
Secondary	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