Socially Assistive Robots to Enhance Magnification Device Use for Reading

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04190134
Collaborator
University of Southern California (Other)
20
1
2
13
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Socially Assistive Robot for Low Vision Rehabilitation
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Activity Inventory [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 Outcome Measures

  1. MNread [For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.]

    reading test

  2. Sustained Silent Reading Test [baseline and monthly for 6 months]

    reading test

  3. Geriatric Depression Scale (GDS) [baseline and monthly for 6 months]

    questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

  4. PANAS [baseline and monthly for 6 months]

    questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods

  5. Perceived Stress Scale [baseline and monthly for 6 months]

    questionnaire; scale ranges from 0 to 56 with higher values indicating greater perceived stress

  6. 3-item UCLA Loneliness Scale [baseline and monthly for 6 months]

    questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness

  7. Duke Social Support Index [baseline and monthly for 6 months]

    questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support

  8. Almere [1 month post-enrollment and 2-3 months after receiving the socially assistive robot]

    questionnaire; scale ranges from 41 to 205 with higher values indicating greater acceptance of robots

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Stein Eye Institute Los Angeles California United States 90095

Sponsors and Collaborators

  • University of California, Los Angeles
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ava K. Bittner, OD, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04190134
Other Study ID Numbers:
  • 19-001429
First Posted:
Dec 9, 2019
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
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
Keywords provided by Ava K. Bittner, OD, PhD, Principal Investigator, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2021