Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision (BeST-AID)

One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued 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, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: UCLA Study Coordinator; Phone Number: 310-267-3977; Email: mestabrook@mednet.ucla.edu

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92831
      • Not yet recruiting
      • Southern Califonia College of Optometry
      • Contact: Patrick Yoshinaga, OD
    • Grass Valley, California, United States, 95945
      • Not yet 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
      • Not yet 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
      • Not yet recruiting
      • See What You Miss Optometry
      • Contact: Lynn Watt Kurata, OD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • New England College of Optometry
      • Contact: Nicole C Ross, OD
    • Brockton, Massachusetts, United States, 02301
      • Not yet recruiting
      • Boston University Eye Associates, Inc.
      • Contact: Lexi G Malkin, OD
  • Michigan
    • Midland, Michigan, United States, 48640
      • Not yet recruiting
      • Mid-Michigan Eye Care
      • Contact: John E Kaminski, OD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Not yet recruiting
      • University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
      • Contact: John Shepherd, MD
  • Virginia
    • Alexandria, Virginia, United States, 22314
      • Not yet recruiting
      • Low Vision Services, PLC: Low Vision Learning Center
      • Contact: Suleiman Alibhai, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults with 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, high near add powers of +4.00 or greater, visual assistive mobile apps for their smartphone/tablet, some stand magnifiers and CCTVs) from one of our participating low vision rehabilitation sites at the four academic centers and one private practice.

Exclusion Criteria:

• schedules not permitting participation in planned study visits (including planning to move far from their clinical provider's office within the first 4-months of the study (i.e., cannot attend in-office visits) or take extended vacation that would not allow them to complete study procedures during the first four months of the study period),
• inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (greater than mild 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., psychosocial).
• For Bluetooth low energy beacon sensors, exclusion would occur if 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), (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation with low vision provider; Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care	Behavioral: Low Vision Rehabilitation; Evaluation and training with magnification or visual assistive devices for visually-impaired adults
Active Comparator: Usual Care In-Office; Low Vision Rehabilitation in-office for use of magnification or visual assistive devices	Behavioral: Low Vision Rehabilitation; Evaluation and training with magnification or visual assistive devices for visually-impaired adults

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)	changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MNread	reading speed and acuity test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Sustained Silent Reading Test	prolonged reading test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
International Reading Speed Text (IReST)	reading speed test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Radner Reading Charts	reading speed and acuity test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Vision rehabilitation satisfaction survey	surveys: post-telerehabilitation or in-office visits	after each session that will occur over a period of 1 to 8 months and and again at about 1 year
Informant surveys by close acquaintances of participants	survey	4 months, 8 months, 12 months, 13 months
Adherence to hand-held optical magnifier use (frequency and duration)	Bluetooth low energy beacon sensor data	baseline to 13 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of Nebraska; Southern California College of Optometry at Marshall B. Ketchum University; New England College of Optometry; Mid-Michigan Eye Care
• Investigators: Principal Investigator: Ava K Bittner, OD, PhD, University of California, Los Angeles

Publications and helpful links

General Publications

• 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.
• 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.
• Bittner AK, Yoshinaga PD, Rittiphairoj T, Li T. Telerehabilitation for people with low vision. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD011019. doi: 10.1002/14651858.CD011019.pub4.
• Malkin AG, Ross NC, Chun MW, Bittner AK; CARE Study Team. Why Are Visual Assistive Mobile Applications Underused by Low Vision Patients? Optom Vis Sci. 2022 Apr 1;99(4):333-334. doi: 10.1097/OPX.0000000000001893. No abstract available.
• Kaminski JE, Yoshinaga PD, Chun MW, Yu M, Shepherd JD, Chan TL, Deemer A, Bittner AK; BeST-AID Study Team. Value of Handheld Optical Illuminated Magnifiers for Sustained Silent Reading by Visually Impaired Adults. Optom Vis Sci. 2023 May 1;100(5):312-318. doi: 10.1097/OPX.0000000000002013. Epub 2023 Mar 22.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 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: BeST-AID 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Please contact the principal investigator

Drug and device information, study documents

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