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Beacon Sensors and Telerehabilitation for Low Vision (BeST-AID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066075
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
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)
Information provided by (Responsible Party):
Ava K. Bittner, OD, PhD, University of California, Los Angeles

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
Low Vision Behavioral: Low Vision Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. Activity Inventory [ Time Frame: 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 [ Time Frame: baseline, 1 month, 4 months ]
    reading test

  2. Sustained Silent Reading Test [ Time Frame: baseline, 1 month, 4 months ]
    reading test

  3. Geriatric Depression Scale (GDS) [ Time Frame: baseline, 1 month, 4 months ]
    questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

  4. Hospital Anxiety & Depression Scale [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066075


Contacts
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Contact: Ava K Bittner, OD, PhD 310-206-4649 abittner@mednet.ucla.edu
Contact: Melissa W Chun, OD 310-206-9566 chun@jsei.ucla.edu

Locations
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United States, California
Southern Califonia College of Optometry Not yet recruiting
Fullerton, California, United States, 92831
Contact: Patrick Yoshinaga, OD         
UCLA Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Ava K Bittner, OD, PhD    310-206-4649      
Principal Investigator: Ava K Bittner, OD, PhD         
Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute Recruiting
San Francisco, California, United States, 94102
Contact: Tiffany Chan, OD         
See What You Miss Optometry Recruiting
Santa Monica, California, United States, 90401
Contact: Lynn Watt Kurata, OD         
United States, Massachusetts
New England College of Optometry Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Nicole C Ross, OD         
Boston University Eye Associates, Inc. Recruiting
Brockton, Massachusetts, United States, 02301
Contact: Lexi G Malkin, OD         
United States, Michigan
Mid-Michigan Eye Care Recruiting
Midland, Michigan, United States, 48640
Contact: John E Kaminski, OD         
United States, Nebraska
University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: John Shepherd, MD         
United States, New York
Eye Vision Associates Recruiting
Nesconset, New York, United States, 11767
Contact: Kristin Protosow, OD         
United States, Virginia
Low Vision Services, PLC: Low Vision Learning Center Recruiting
Alexandria, Virginia, United States, 22314
Contact: Suleiman Alibhai, OD         
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
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Principal Investigator: Ava K Bittner, OD, PhD UCLA Stein Eye Institute
Publications:
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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: August 26, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms