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

Low Vision Clinical Trial

— BeST-AID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107881
• Other study ID #: BeST-AID 2.0
• Status: Recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: October 2023
• Source: University of California, Los Angeles
• Contact: UCLA Study Coordinator
• Phone: 310-267-3977
• Email: mestabrook[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Vision
• Low Vision Aids
• Vision, Low

Intervention

Behavioral:
• Low Vision Rehabilitation
Evaluation and training with magnification or visual assistive devices for visually-impaired adults

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	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 (5)

Lead Sponsor	Collaborator
University of California, Los Angeles	Mid-Michigan Eye Care, New England College of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (8)

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, 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. — 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; 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. — View 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. — 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)	changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device
Secondary	MNread	reading speed and acuity test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Secondary	Sustained Silent Reading Test	prolonged reading test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Secondary	International Reading Speed Text (IReST)	reading speed test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Secondary	Radner Reading Charts	reading speed and acuity test	baseline, 1 month, 4 months, 8 months, 12 months, 13 months
Secondary	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
Secondary	Informant surveys by close acquaintances of participants	survey	4 months, 8 months, 12 months, 13 months
Secondary	Adherence to hand-held optical magnifier use (frequency and duration)	Bluetooth low energy beacon sensor data	baseline to 13 months