BeST-AID: Beacon Sensors and Telerehabilitation for Low Vision

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04066075
Collaborator
National Eye Institute (NEI) (NIH), American Academy of Optometry (funding) (Other), Southern California College of Optometry (study site) (Other), New England College of Optometry (Other), University of Nebraska Medical Center, Dept. of Ophthalmology (study site) (Other), Mid-Michigan Eye Care (study site) (Other), Eye Vision Associates (study site) (Other), See What You Miss Optometry (study site) (Other), Low Vision Learning Center (study site) (Other), Frank Stein & Paul S. May Center for Low Vision Rehabilitation (study site) (Other), Boston University Eye Associates, Inc. (study site) (Other)
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33
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Study Details

Study Description

Brief Summary

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.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telerehabilitation with low vision provider

Behavioral: Low Vision Rehabilitation
Low Vision Rehabilitation for use of magnification devices for near reading tasks

Experimental: Telerehabilitation w/ low vision provider plus tele-extender

Behavioral: Low Vision Rehabilitation
Low Vision Rehabilitation for use of magnification devices for near reading tasks

Active Comparator: Usual Care (active control)

Behavioral: Low Vision Rehabilitation
Low Vision Rehabilitation for use of magnification devices for near reading tasks

Outcome Measures

Primary Outcome Measures

  1. Activity Inventory [change from 1 month to 4 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]

    reading test

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

    reading test

  3. Geriatric Depression Scale (GDS) [baseline, 1 month, 4 months]

    questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

  4. Hospital Anxiety & Depression Scale [baseline, 1 month, 4 months]

    questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 1"x1" to which the beacon sensor could be attached without interfering with the device.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern Califonia College of Optometry Fullerton California United States 92831
2 UCLA Stein Eye Institute Los Angeles California United States 90095
3 Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute San Francisco California United States 94102
4 See What You Miss Optometry Santa Monica California United States 90401
5 New England College of Optometry Boston Massachusetts United States 02115
6 Boston University Eye Associates, Inc. Brockton Massachusetts United States 02301
7 Mid-Michigan Eye Care Midland Michigan United States 48640
8 University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute Omaha Nebraska United States 68198
9 Eye Vision Associates Nesconset New York United States 11767
10 Low Vision Services, PLC: Low Vision Learning Center Alexandria Virginia United States 22314

Sponsors and Collaborators

  • University of California, Los Angeles
  • National Eye Institute (NEI)
  • American Academy of Optometry (funding)
  • Southern California College of Optometry (study site)
  • New England College of Optometry
  • University of Nebraska Medical Center, Dept. of Ophthalmology (study site)
  • Mid-Michigan Eye Care (study site)
  • Eye Vision Associates (study site)
  • See What You Miss Optometry (study site)
  • Low Vision Learning Center (study site)
  • Frank Stein & Paul S. May Center for Low Vision Rehabilitation (study site)
  • Boston University Eye Associates, Inc. (study site)

Investigators

  • Principal Investigator: Ava K Bittner, OD, PhD, UCLA Stein Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ava K. Bittner, OD, PhD, Associate Professor of Ophthalmology, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04066075
Other Study ID Numbers:
  • #19-000267 and #18-002041
First Posted:
Aug 26, 2019
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
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:

Study Results

No Results Posted as of Apr 29, 2021