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

• ClinicalTrials.gov Identifier: NCT04066075
• Recruitment Status: Recruiting
• First Posted: August 26, 2019
• Last Update Posted: May 19, 2023
• Sponsor: University of California, Los Angeles
• Collaborators: National Eye Institute (NEI); American Academy of Optometry (funding); Southern California College of Optometry (study site); New England College of Optometry; 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)
• Information provided by (Responsible Party): Ava K. Bittner, OD, PhD, University of California, Los Angeles

Tracking Information

• First Submitted Date: August 19, 2019
• First Posted Date: August 26, 2019
• Last Update Posted Date: May 19, 2023
• Actual Study Start Date: October 1, 2019
• Estimated Primary Completion Date: December 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2019)

Activity Inventory [ Time Frame: change from 1 month to 4 months after receiving a magnification device ]

questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 20, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Beacon Sensors and Telerehabilitation for Low Vision
• Official Title: Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Low Vision

Intervention

Behavioral: Low Vision Rehabilitation

Low Vision Rehabilitation for use of magnification devices for near reading tasks

Study Arms

• Experimental: Telerehabilitation with low vision provider
  Intervention: Behavioral: Low Vision Rehabilitation
• Experimental: Telerehabilitation w/ low vision provider plus tele-extender
  Intervention: Behavioral: Low Vision Rehabilitation
• Active Comparator: Usual Care (active control)
  Intervention: Behavioral: Low Vision Rehabilitation

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 20, 2019): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 28, 2023
• Estimated Primary Completion Date: December 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ava K Bittner, OD, PhD; 310-206-4649; abittner@mednet.ucla.edu

Contact: Max Estabrook; 310-267-3977; mestabrook@mednet.ucla.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04066075
• Other Study ID Numbers: #19-000267 and #18-002041
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ava K. Bittner, OD, PhD, University of California, Los Angeles
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: Same as current

Collaborators

• National Eye Institute (NEI)
• American Academy of Optometry (funding)
• Southern California College of Optometry (study site)
• New England College of Optometry
• 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

• PRS Account: University of California, Los Angeles
• Verification Date: May 2023