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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06107881
• Collaborator: University of Nebraska (Other), New England College of Optometry (Other), Southern California College of Optometry at Marshall B. Ketchum University (Other), Mid-Michigan Eye Care (Other)
• Enrollment: 350
• Locations: 10
• Arms: 2
• Anticipated Duration (Months): 57
• Patients Per Site: 35
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Vision; Low Vision Aids	Behavioral: Low Vision Rehabilitation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled non-inferiority trialrandomized controlled non-inferiority trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2028
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telerehabilitation with low vision provider Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care	Behavioral: Low Vision Rehabilitation; Evaluation and training with magnification or visual assistive devices for visually-impaired adults
Active Comparator: Usual Care In-Office Low Vision Rehabilitation in-office for use of magnification or visual assistive devices	Behavioral: Low Vision Rehabilitation; Evaluation and training with magnification or visual assistive devices for visually-impaired adults

Outcome Measures

Primary Outcome Measures

1. Activity Inventory [changes from 1 month to 4 months to 8 months to 12 months to 13 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)

Secondary Outcome Measures

1. MNread [baseline, 1 month, 4 months, 8 months, 12 months, 13 months]

   reading speed and acuity test

2. Sustained Silent Reading Test [baseline, 1 month, 4 months, 8 months, 12 months, 13 months]

   prolonged reading test

3. International Reading Speed Text (IReST) [baseline, 1 month, 4 months, 8 months, 12 months, 13 months]

   reading speed test

4. Radner Reading Charts [baseline, 1 month, 4 months, 8 months, 12 months, 13 months]

   reading speed and acuity test

5. Vision rehabilitation satisfaction survey [after each session that will occur over a period of 1 to 8 months and and again at about 1 year]

   surveys: post-telerehabilitation or in-office visits

6. Informant surveys by close acquaintances of participants [4 months, 8 months, 12 months, 13 months]

   survey

7. Adherence to hand-held optical magnifier use (frequency and duration) [baseline to 13 months]

   Bluetooth low energy beacon sensor data

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Califonia College of Optometry	Fullerton	California	United States	92831
2	Chan Family Optometry	Grass Valley	California	United States	95945
3	UCLA Stein Eye Institute	Los Angeles	California	United States	90095
4	Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute	San Francisco	California	United States	94102
5	See What You Miss Optometry	Santa Monica	California	United States	90401
6	New England College of Optometry	Boston	Massachusetts	United States	02115
7	Boston University Eye Associates, Inc.	Brockton	Massachusetts	United States	02301
8	Mid-Michigan Eye Care	Midland	Michigan	United States	48640
9	University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute	Omaha	Nebraska	United States	68198
10	Low Vision Services, PLC: Low Vision Learning Center	Alexandria	Virginia	United States	22314

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ava K Bittner, OD, PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ava K. Bittner, OD, PhD, Associate Professor of Ophthalmology, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT06107881
• Other Study ID Numbers: BeST-AID 2.0
• First Posted: Oct 30, 2023
• Last Update Posted: Oct 30, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vision, Low

Study Results

No Results Posted as of Oct 30, 2023