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

Study Overview
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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.

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

Conditions
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Low Vision, Low Vision Aids

Intervention / Treatment
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* Behavioral: Low Vision Rehabilitation


Participation Criteria
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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 1x1 to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled non-inferiority trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MNread | reading speed and acuity test | baseline, 1 month, 4 months, 8 months, 12 months, 13 months | 
| Sustained Silent Reading Test | prolonged reading test | baseline, 1 month, 4 months, 8 months, 12 months, 13 months | 
| International Reading Speed Text (IReST) | reading speed test | baseline, 1 month, 4 months, 8 months, 12 months, 13 months | 
| Radner Reading Charts | reading speed and acuity test | baseline, 1 month, 4 months, 8 months, 12 months, 13 months | 
| 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 | 
| Informant surveys by close acquaintances of participants | survey | 4 months, 8 months, 12 months, 13 months | 
| Adherence to hand-held optical magnifier use (frequency and duration) | Bluetooth low energy beacon sensor data | baseline to 13 months |