Clinical trial NCT04190134: Socially Assistive Robots to Enhance Magnification Device Use for Reading
Official title: Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Low Vision
Keywords: robot
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2019-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Activity Inventory
timeFrame: change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot
Secondary outcomes:
measure: MNread
timeFrame: For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.
measure: Sustained Silent Reading Test
timeFrame: baseline and monthly for 6 months
measure: Geriatric Depression Scale (GDS)
timeFrame: baseline and monthly for 6 months
measure: PANAS
timeFrame: baseline and monthly for 6 months
measure: Perceived Stress Scale
timeFrame: baseline and monthly for 6 months
measure: 3-item UCLA Loneliness Scale
timeFrame: baseline and monthly for 6 months
measure: Duke Social Support Index
timeFrame: baseline and monthly for 6 months
measure: Almere
timeFrame: 1 month post-enrollment and 2-3 months after receiving the socially assistive robot
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Stein Eye Institute
state: California
Study officials:
affiliation: UCLA Stein Eye Institute; Vision Rehabilitation Center
name: Ava K Bittner, OD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USC Interaction Lab; Viterbi School of Engineering
name: Maja J Mataric, PhD
role: PRINCIPAL_INVESTIGATOR
References: