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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06107881
Acronym
BeST-AID
Enrollment
350
Registered
2023-10-30
Start date
2023-12-15
Completion date
2028-06-30
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Vision, Low Vision Aids

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.

Interventions

Evaluation and training with magnification or visual assistive devices for visually-impaired adults

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

randomized controlled non-inferiority trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 1x1 to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.

Design outcomes

Primary

MeasureTime frameDescription
Activity Inventorychanges from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification devicequestionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

Secondary

MeasureTime frameDescription
MNreadbaseline, 1 month, 4 months, 8 months, 12 months, 13 monthsreading speed and acuity test
International Reading Speed Text (IReST)baseline, 1 month, 4 months, 8 months, 12 months, 13 monthsreading speed test
Radner Reading Chartsbaseline, 1 month, 4 months, 8 months, 12 months, 13 monthsreading speed and acuity test
Sustained Silent Reading Testbaseline, 1 month, 4 months, 8 months, 12 months, 13 monthsprolonged reading test
Informant surveys by close acquaintances of participants4 months, 8 months, 12 months, 13 monthssurvey
Adherence to hand-held optical magnifier use (frequency and duration)baseline to 13 monthsBluetooth low energy beacon sensor data
Vision rehabilitation satisfaction surveyafter each session that will occur over a period of 1 to 8 months and and again at about 1 yearsurveys: post-telerehabilitation or in-office visits

Countries

United States

Contacts

Primary ContactUCLA Study Coordinator
JessicaSLin@mednet.ucla.edu310-794-5602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026