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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Vision Low Vision Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telerehabilitation with low vision provider

Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care

Group Type EXPERIMENTAL

Low Vision Rehabilitation

Intervention Type BEHAVIORAL

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

Usual Care In-Office

Low Vision Rehabilitation in-office for use of magnification or visual assistive devices

Group Type ACTIVE_COMPARATOR

Low Vision Rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Low Vision Rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ava K. Bittner, OD, PhD

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ava K Bittner, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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