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NCT Number: NCT04190134

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.

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Key information

Conditions

Low Vision Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Vision, Low

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA Stein Eye Institute

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Ava K Bittner, OD, PhD

CONTACT

310-206-4649

Ava K Bittner, OD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Socially Assistive Robot for Low Vision Rehabilitation

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Obligacion

CONTACT

[email protected]

310-206-9566

Ava K Bittner, OD, PhD

CONTACT

[email protected]

310-206-4649

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • University of Southern California

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2019
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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