Beacon Sensors and Telerehabilitation for Low Vision

Low Vision Clinical Trial

— BeST-AID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066075
• Other study ID #: #19-000267 and #18-002041
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 28, 2023

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: Ava K Bittner, OD, PhD
• Phone: 310-206-4649
• Email: abittner[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Vision
• Vision, Low

Intervention

Behavioral:
• Low Vision Rehabilitation
Low Vision Rehabilitation for use of magnification devices for near reading tasks

Locations

Country	Name	City	State
United States	Low Vision Services, PLC: Low Vision Learning Center	Alexandria	Virginia
United States	New England College of Optometry	Boston	Massachusetts
United States	Boston University Eye Associates, Inc.	Brockton	Massachusetts
United States	Southern Califonia College of Optometry	Fullerton	California
United States	Chan Family Optometry	Grass Valley	California
United States	UCLA Stein Eye Institute	Los Angeles	California
United States	Mid-Michigan Eye Care	Midland	Michigan
United States	Eye Vision Associates	Nesconset	New York
United States	University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute	Omaha	Nebraska
United States	Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute	San Francisco	California
United States	See What You Miss Optometry	Santa Monica	California

Sponsors (12)

Lead Sponsor

Collaborator

University of California, Los Angeles

American Academy of Optometry (funding), Boston University Eye Associates, Inc. (study site), Eye Vision Associates (study site), Frank Stein & Paul S. May Center for Low Vision Rehabilitation (study site), Low Vision Learning Center (study site), Mid-Michigan Eye Care (study site), National Eye Institute (NEI), New England College of Optometry, See What You Miss Optometry (study site), Southern California College of Optometry (study site), University of Nebraska Medical Center, Dept. of Ophthalmology (study site)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 Access — View Citation

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MNread	reading test	baseline, 1 month, 4 months
Secondary	Sustained Silent Reading Test	reading test	baseline, 1 month, 4 months
Secondary	Geriatric Depression Scale (GDS)	questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression	baseline, 1 month, 4 months
Secondary	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