Beacon Sensors and Telerehabilitation for Low Vision

Study Overview
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Brief Summary
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The successful application of magnification devices for reading and daily tasks is predicated on their correct use by individuals with low vision (LV). Barriers related to transportation, geography, and/or co-morbidities often limit LV patients' ability to attend several in-office training sessions as part of low vision rehabilitation (LVR) to optimize visual function with magnification devices. A promising solution is real-time videoconferencing to provide telerehabilitation, involving remotely delivered LVR services by a LVR provider in office to a patient at home. Telerehabilitation for LV appears to be feasible and acceptable by both patients and LVR providers, yet there are no published outcomes on the potential to improve patients' visual functioning. Another key issue in LVR is the need for an effective system to continually assess how patients are functioning at home. Ideally this would involve a non-invasive, efficient method to assess when magnifier device abandonment occurs, so that a timely telerehabilitation session can be initiated. Small Bluetooth low energy beacon sensors attached to the handles of magnifiers can collect real-time data regarding minute-to-minute environmental changes, which might serve as an indicator of magnifier use by LV patients at home. Specifically, the investigators propose to assess the potential for telerehabilitation to enhance visual function by providing remotely-delivered LVR training to use magnification devices. Following one in-office training session for new magnification device(s), the investigators aim to determine if there is additional gain in visual functioning by randomizing subjects to telerehabilitation or additional in-office LVR (active control). Participants will be assessed before and after two consecutive periods: (1) one month after a single LVR training session, followed by (2) up to three LVR sessions over a three month period either via telerehabilitation in the participants' homes or LVR in-office. The investigators will determine which patient characteristics and/or magnification devices are most likely to benefit from telerehabilitation. The investigators will also determine whether data from Bluetooth beacon sensors are valid indicators of hand-held magnifier device usage by LV patients at home. The study investigators will deploy Estimote Sticker beacon sensors to subjects randomized to telerehabilitation or additional in-office LVR during the same study period. It is anticipated that beacon sensors will measure significantly increased temperature and/or motion when placed on the part of the magnification device held by LV patients while performing daily activities. Beacon sensor data will determine if it is feasible to assess when magnification devices are used, and if the frequency of magnifier use changes following telerehabilitation or in-office LVR. This work will evaluate and refine the procedures for implementing these technologies for LVR, in order to develop future randomized controlled trial protocols. The investigators envision that telerehabilitation and beacon sensors could improve LV patient outcomes by providing follow-up LVR services in a more efficient and timely manner.

Official Title
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Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning

Conditions
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Low Vision

Intervention / Treatment
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* Behavioral: Low Vision Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, some stand magnifiers and CCTVs) from one of our participating sites. Exclusion Criteria: schedules not permitting participation in planned study visits (including planning to move or take extended vacation during study period), inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (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., technology/computer skills, psychosocial), 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), and/or (2) no surface area of at least 1x1 to which the beacon sensor could be attached without interfering with the device.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation with low vision provider<br> | Behavioral: Low Vision Rehabilitation<br>* Low Vision Rehabilitation for use of magnification devices for near reading tasks<br>|
| Experimental: Telerehabilitation w/ low vision provider plus tele-extender<br> | Behavioral: Low Vision Rehabilitation<br>* Low Vision Rehabilitation for use of magnification devices for near reading tasks<br>|
| Active Comparator: Usual Care (active control)<br> | Behavioral: Low Vision Rehabilitation<br>* Low Vision Rehabilitation for use of magnification devices for near reading tasks<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) | change from 1 month to 4 months after receiving a magnification device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MNread | reading test | baseline, 1 month, 4 months | 
| Sustained Silent Reading Test | reading test | baseline, 1 month, 4 months | 
| Geriatric Depression Scale (GDS) | questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression | baseline, 1 month, 4 months | 
| Hospital Anxiety & Depression Scale | questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety | baseline, 1 month, 4 months |