Beacon Sensors and Telerehabilitation for Low Vision (BeST-AID)

Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning

The successful application of magnification devices for reading and daily tasks is predicated on their correct use by individuals with low vision (LV). Barriers related to transportation, geography, and/or co-morbidities often limit LV patients' ability to attend several in-office training sessions as part of low vision rehabilitation (LVR) to optimize visual function with magnification devices. A promising solution is real-time videoconferencing to provide telerehabilitation, involving remotely delivered LVR services by a LVR provider in office to a patient at home. Telerehabilitation for LV appears to be feasible and acceptable by both patients and LVR providers, yet there are no published outcomes on the potential to improve patients' visual functioning. Another key issue in LVR is the need for an effective system to continually assess how patients are functioning at home. Ideally this would involve a non-invasive, efficient method to assess when magnifier device abandonment occurs, so that a timely telerehabilitation session can be initiated. Small Bluetooth low energy beacon sensors attached to the handles of magnifiers can collect real-time data regarding minute-to-minute environmental changes, which might serve as an indicator of magnifier use by LV patients at home. Specifically, the investigators propose to assess the potential for telerehabilitation to enhance visual function by providing remotely-delivered LVR training to use magnification devices. Following one in-office training session for new magnification device(s), the investigators aim to determine if there is additional gain in visual functioning by randomizing subjects to telerehabilitation or additional in-office LVR (active control). Participants will be assessed before and after two consecutive periods: (1) one month after a single LVR training session, followed by (2) up to three LVR sessions over a three month period either via telerehabilitation in the participants' homes or LVR in-office. The investigators will determine which patient characteristics and/or magnification devices are most likely to benefit from telerehabilitation. The investigators will also determine whether data from Bluetooth beacon sensors are valid indicators of hand-held magnifier device usage by LV patients at home. The study investigators will deploy Estimote Sticker beacon sensors to subjects randomized to telerehabilitation or additional in-office LVR during the same study period. It is anticipated that beacon sensors will measure significantly increased temperature and/or motion when placed on the part of the magnification device held by LV patients while performing daily activities. Beacon sensor data will determine if it is feasible to assess when magnification devices are used, and if the frequency of magnifier use changes following telerehabilitation or in-office LVR. This work will evaluate and refine the procedures for implementing these technologies for LVR, in order to develop future randomized controlled trial protocols. The investigators envision that telerehabilitation and beacon sensors could improve LV patient outcomes by providing follow-up LVR services in a more efficient and timely manner.

Study Overview

• Status: Recruiting
• Conditions: Low Vision
• Intervention / Treatment: Behavioral: Low Vision Rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ava K Bittner, OD, PhD; Phone Number: 310-206-4649; Email: abittner@mednet.ucla.edu
• Study Contact Backup: Name: Max Estabrook; Phone Number: 310-267-3977; Email: mestabrook@mednet.ucla.edu

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92831
      • Recruiting
      • Southern Califonia College of Optometry
      • Contact: Patrick Yoshinaga, OD
    • Grass Valley, California, United States, 95945
      • Recruiting
      • Chan Family Optometry
      • Contact: Tiffany L Chan, OD
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Stein Eye Institute
      • Contact: Ava K Bittner, OD, PhD; Phone Number: 310-206-4649
      • Principal Investigator: Ava K Bittner, OD, PhD
    • San Francisco, California, United States, 94102
      • Recruiting
      • Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
      • Contact: Tiffany Chan, OD
    • Santa Monica, California, United States, 90401
      • Recruiting
      • See What You Miss Optometry
      • Contact: Lynn Watt Kurata, OD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • New England College of Optometry
      • Contact: Nicole C Ross, OD
    • Brockton, Massachusetts, United States, 02301
      • Recruiting
      • Boston University Eye Associates, Inc.
      • Contact: Lexi G Malkin, OD
  • Michigan
    • Midland, Michigan, United States, 48640
      • Recruiting
      • Mid-Michigan Eye Care
      • Contact: John E Kaminski, OD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
      • Contact: John Shepherd, MD
  • New York
    • Nesconset, New York, United States, 11767
      • Recruiting
      • Eye Vision Associates
      • Contact: Kristin Protosow, OD
  • Virginia
    • Alexandria, Virginia, United States, 22314
      • Recruiting
      • Low Vision Services, PLC: Low Vision Learning Center
      • Contact: Suleiman Alibhai, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any level of vision loss due to any ocular disease who are age 18 and older, and who have received new magnification device(s) for the first time (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and CCTVs) from one of our participating sites.

Exclusion Criteria:

• schedules not permitting participation in planned study 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 via videoconferencing),
• significant medical condition likely to limit participation or lifespan, individuals who require other types of LVR training or intervention (e.g., technology/computer skills, psychosocial),
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation with low vision provider	Behavioral: Low Vision Rehabilitation; Low Vision Rehabilitation for use of magnification devices for near reading tasks
Experimental: Telerehabilitation w/ low vision provider plus tele-extender	Behavioral: Low Vision Rehabilitation; Low Vision Rehabilitation for use of magnification devices for near reading tasks
Active Comparator: Usual Care (active control)	Behavioral: Low Vision Rehabilitation; Low Vision Rehabilitation for use of magnification devices for near reading tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 to 4 months after receiving a magnification device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MNread	reading test	baseline, 1 month, 4 months
Sustained Silent Reading Test	reading test	baseline, 1 month, 4 months
Geriatric Depression Scale (GDS)	questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression	baseline, 1 month, 4 months
Hospital Anxiety & Depression Scale	questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety	baseline, 1 month, 4 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Eye Institute (NEI); New England College of Optometry; American Academy of Optometry (funding); Southern California College of Optometry (study site); University of Nebraska Medical Center, Dept. of Ophthalmology (study site); Mid-Michigan Eye Care (study site); Eye Vision Associates (study site); See What You Miss Optometry (study site); Low Vision Learning Center (study site); Frank Stein & Paul S. May Center for Low Vision Rehabilitation (study site); Boston University Eye Associates, Inc. (study site)
• Investigators: Principal Investigator: Ava K Bittner, OD, PhD, UCLA Stein Eye Institute

Publications and helpful links

General Publications

• Bittner AK, Yoshinaga P, Bowers A, Shepherd JD, Succar T, Ross NC. Feasibility of Telerehabilitation for Low Vision: Satisfaction Ratings by Providers and Patients. Optom Vis Sci. 2018 Sep;95(9):865-872. doi: 10.1097/OPX.0000000000001260.
• Bittner AK, Jacobson AJ, Khan R. Feasibility of Using Bluetooth Low Energy Beacon Sensors to Detect Magnifier Usage by Low Vision Patients. Optom Vis Sci. 2018 Sep;95(9):844-851. doi: 10.1097/OPX.0000000000001266.
• Bittner AK, Yoshinaga PD, Shepherd JD, Kaminski JE, Malkin AG, Chun MW, Chan TL, Deemer AD, Ross NC; BeST-AID Study Team. Acceptability of Telerehabilitation for Magnification Devices for the Visually Impaired Using Various Approaches to Facilitate Accessibility. Transl Vis Sci Technol. 2022 Aug 1;11(8):4. doi: 10.1167/tvst.11.8.4.
• Bittner AK, Estabrook M, Dennis N. Bluetooth Low Energy Beacon Sensors to Document Handheld Magnifier Use at Home by People with Low Vision. Sensors (Basel). 2021 Oct 25;21(21):7065. doi: 10.3390/s21217065.
• Kaminski JE, Yoshinaga PD, Chun MW, Yu M, Shepherd JD, Chan TL, Deemer A, Bittner AK; and the BeST-AID Study Team. Value of Hand-held Optical Illuminated Magnifiers for Sustained Silent Reading by Visually-Impaired Adults. Optom Vis Sci. 2023 Mar 22. doi: 10.1097/OPX.0000000000002013. Online ahead of print.
• Bittner AK, Kaminski JE, Ross NC, Shepherd JD, Thoene SJ, Bui SZ, Yoshinaga PD; BeST-AID Study Team. Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision. Optom Vis Sci. 2022 Oct 1;99(10):743-749. doi: 10.1097/OPX.0000000000001944. Epub 2022 Sep 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 28, 2023
• Study Completion (Anticipated): December 28, 2023

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Vision, Low
• Other Study ID Numbers: #19-000267 and #18-002041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No