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Socially Assistive Robots to Enhance Magnification Device Use for Reading

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190134
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : May 19, 2023
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Ava K. Bittner, OD, PhD, University of California, Los Angeles

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Low Vision Behavioral: Socially Assistive Robot for Low Vision Rehabilitation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : April 22, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. MNread [ Time Frame: 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 [ Time Frame: baseline and monthly for 6 months ]
    reading test

  3. Geriatric Depression Scale (GDS) [ Time Frame: baseline and monthly for 6 months ]
    questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

  4. PANAS [ Time Frame: baseline and monthly for 6 months ]
    questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods

  5. Perceived Stress Scale [ Time Frame: 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 [ Time Frame: baseline and monthly for 6 months ]
    questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness

  7. Duke Social Support Index [ Time Frame: baseline and monthly for 6 months ]
    questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support

  8. Almere [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190134


Contacts
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Contact: Ava K Bittner, OD, PhD 310-206-4649 abittner@mednet.ucla.edu
Contact: Max Estabrook 310-206-9566 mestabrook@mednet.ucla.edu

Locations
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United States, California
UCLA Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Ava K Bittner, OD, PhD    310-206-4649      
Principal Investigator: Ava K Bittner, OD, PhD         
Sponsors and Collaborators
University of California, Los Angeles
University of Southern California
Investigators
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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
More Information
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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: December 9, 2019    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023

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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, University of California, Los Angeles:
robot
Additional relevant MeSH terms:
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Vision, Low
Vision Disorders
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Eye Diseases