Clinical trial NCT04066075: Beacon Sensors and Telerehabilitation for Low Vision
Official title: Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: American Academy of Optometry
name: Southern California College of Optometry at Marshall B. Ketchum University
name: New England College of Optometry
name: University of Nebraska
name: Mid Michigan Health Centers
name: Eye Vision Associates
name: See What You Miss Optometry
name: Low Vision Services, PLC
name: Pacific Vision Foundation
name: Boston University
First posted: 2019-08-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Activity Inventory
timeFrame: change from 1 month to 4 months after receiving a magnification device
Secondary outcomes:
measure: MNread
timeFrame: baseline, 1 month, 4 months
measure: Sustained Silent Reading Test
timeFrame: baseline, 1 month, 4 months
measure: Geriatric Depression Scale (GDS)
timeFrame: baseline, 1 month, 4 months
measure: Hospital Anxiety & Depression Scale
timeFrame: baseline, 1 month, 4 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern Califonia College of Optometry
state: California
city: Grass Valley
country: United States
facility: Chan Family Optometry
state: California
city: Los Angeles
country: United States
facility: UCLA Stein Eye Institute
state: California
city: San Francisco
country: United States
facility: Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
state: California
city: Santa Monica
country: United States
facility: See What You Miss Optometry
state: California
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Brockton
country: United States
facility: Boston University Eye Associates, Inc.
state: Massachusetts
city: Midland
country: United States
facility: Mid-Michigan Eye Care
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
state: Nebraska
city: Nesconset
country: United States
facility: Eye Vision Associates
state: New York
city: Alexandria
country: United States
facility: Low Vision Services, PLC: Low Vision Learning Center
state: Virginia
Study officials:
affiliation: UCLA Stein Eye Institute
name: Ava K Bittner, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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 Accessibility. Transl Vis Sci Technol. 2022 Aug 1;11(8):4. doi: 10.1167/tvst.11.8.4.
citation: 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.
citation: 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.
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. doi: 10.1097/OPX.0000000000001944. Epub 2022 Sep 6.
citation: Bittner AK, Kaminski JE, Yoshinaga PD, Shepherd JD, Chan TL, Malkin AG, Deemer A, Gobeille M, Thoene SJ, Rossi A, Ross NC; BeST-AID Study Team. Outcomes of Telerehabilitation Versus In-Office Training With Magnification Devices for Low Vision: A Randomized Controlled Trial. Transl Vis Sci Technol. 2024 Jan 2;13(1):6. doi: 10.1167/tvst.13.1.6.