Clinical trial NCT06107881: Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
Official title: Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Vision
Low Vision Aids
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: New England College of Optometry
name: Southern California College of Optometry at Marshall B. Ketchum University
name: Mid-Michigan Eye Care
First posted: 2023-10-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled non-inferiority trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Activity Inventory
timeFrame: changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device
Secondary outcomes:
measure: MNread
timeFrame: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
measure: Sustained Silent Reading Test
timeFrame: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
measure: International Reading Speed Text (IReST)
timeFrame: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
measure: Radner Reading Charts
timeFrame: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
measure: Vision rehabilitation satisfaction survey
timeFrame: after each session that will occur over a period of 1 to 8 months and and again at about 1 year
measure: Informant surveys by close acquaintances of participants
timeFrame: 4 months, 8 months, 12 months, 13 months
measure: Adherence to hand-held optical magnifier use (frequency and duration)
timeFrame: baseline to 13 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: Alexandria
country: United States
facility: Low Vision Services, PLC: Low Vision Learning Center
state: Virginia
Study officials:
affiliation: University of California, Los Angeles
name: Ava K Bittner, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.
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, 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: 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.