Beacon Sensors and Telerehabilitation for Low Vision (BeST-AID)
Primary Purpose
Low Vision
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Vision Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Low Vision
Eligibility 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.
Sites / Locations
- Southern Califonia College of OptometryRecruiting
- Chan Family OptometryRecruiting
- UCLA Stein Eye InstituteRecruiting
- Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye InstituteRecruiting
- See What You Miss OptometryRecruiting
- New England College of OptometryRecruiting
- Boston University Eye Associates, Inc.Recruiting
- Mid-Michigan Eye CareRecruiting
- University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye InstituteRecruiting
- Eye Vision AssociatesRecruiting
- Low Vision Services, PLC: Low Vision Learning CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Telerehabilitation with low vision provider
Telerehabilitation w/ low vision provider plus tele-extender
Usual Care (active control)
Arm Description
Outcomes
Primary Outcome Measures
Activity Inventory
questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
Secondary Outcome Measures
MNread
reading test
Sustained Silent Reading Test
reading test
Geriatric Depression Scale (GDS)
questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
Hospital Anxiety & Depression Scale
questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety
Full Information
NCT ID
NCT04066075
First Posted
August 19, 2019
Last Updated
May 17, 2023
Sponsor
University of California, Los Angeles
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)
1. Study Identification
Unique Protocol Identification Number
NCT04066075
Brief Title
Beacon Sensors and Telerehabilitation for Low Vision
Acronym
BeST-AID
Official Title
Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation with low vision provider
Arm Type
Experimental
Arm Title
Telerehabilitation w/ low vision provider plus tele-extender
Arm Type
Experimental
Arm Title
Usual Care (active control)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Low Vision Rehabilitation
Intervention Description
Low Vision Rehabilitation for use of magnification devices for near reading tasks
Primary Outcome Measure Information:
Title
Activity Inventory
Description
questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
Time Frame
change from 1 month to 4 months after receiving a magnification device
Secondary Outcome Measure Information:
Title
MNread
Description
reading test
Time Frame
baseline, 1 month, 4 months
Title
Sustained Silent Reading Test
Description
reading test
Time Frame
baseline, 1 month, 4 months
Title
Geriatric Depression Scale (GDS)
Description
questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
Time Frame
baseline, 1 month, 4 months
Title
Hospital Anxiety & Depression Scale
Description
questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety
Time Frame
baseline, 1 month, 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ava K Bittner, OD, PhD
Phone
310-206-4649
Email
abittner@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Max Estabrook
Phone
310-267-3977
Email
mestabrook@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ava K Bittner, OD, PhD
Organizational Affiliation
UCLA Stein Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Califonia College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Yoshinaga, OD
Facility Name
Chan Family Optometry
City
Grass Valley
State/Province
California
ZIP/Postal Code
95945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany L Chan, OD
Facility Name
UCLA Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ava K Bittner, OD, PhD
Phone
310-206-4649
First Name & Middle Initial & Last Name & Degree
Ava K Bittner, OD, PhD
Facility Name
Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Chan, OD
Facility Name
See What You Miss Optometry
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Watt Kurata, OD
Facility Name
New England College of Optometry
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole C Ross, OD
Facility Name
Boston University Eye Associates, Inc.
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lexi G Malkin, OD
Facility Name
Mid-Michigan Eye Care
City
Midland
State/Province
Michigan
ZIP/Postal Code
48640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John E Kaminski, OD
Facility Name
University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Shepherd, MD
Facility Name
Eye Vision Associates
City
Nesconset
State/Province
New York
ZIP/Postal Code
11767
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Protosow, OD
Facility Name
Low Vision Services, PLC: Low Vision Learning Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suleiman Alibhai, OD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30169361
Citation
Bittner AK, Yoshinaga P, Bowers A, Shepherd JD, Succar T, Ross NC. Feasibility of Telerehabilitation for Low Vision: Satisfaction Ratings by Providers and Patients. Optom Vis Sci. 2018 Sep;95(9):865-872. doi: 10.1097/OPX.0000000000001260.
Results Reference
background
PubMed Identifier
30169359
Citation
Bittner AK, Jacobson AJ, Khan R. Feasibility of Using Bluetooth Low Energy Beacon Sensors to Detect Magnifier Usage by Low Vision Patients. Optom Vis Sci. 2018 Sep;95(9):844-851. doi: 10.1097/OPX.0000000000001266.
Results Reference
background
PubMed Identifier
35917136
Citation
Bittner AK, Yoshinaga PD, Shepherd JD, Kaminski JE, Malkin AG, Chun MW, Chan TL, Deemer AD, Ross NC; BeST-AID Study Team. Acceptability of Telerehabilitation for Magnification Devices for the Visually Impaired Using Various Approaches to Facilitate Accessibility. Transl Vis Sci Technol. 2022 Aug 1;11(8):4. doi: 10.1167/tvst.11.8.4.
Results Reference
result
PubMed Identifier
34770374
Citation
Bittner AK, Estabrook M, Dennis N. Bluetooth Low Energy Beacon Sensors to Document Handheld Magnifier Use at Home by People with Low Vision. Sensors (Basel). 2021 Oct 25;21(21):7065. doi: 10.3390/s21217065.
Results Reference
result
PubMed Identifier
36951854
Citation
Kaminski JE, Yoshinaga PD, Chun MW, Yu M, Shepherd JD, Chan TL, Deemer A, Bittner AK; BeST-AID Study Team. Value of Handheld Optical Illuminated Magnifiers for Sustained Silent Reading by Visually Impaired Adults. Optom Vis Sci. 2023 May 1;100(5):312-318. doi: 10.1097/OPX.0000000000002013. Epub 2023 Mar 22.
Results Reference
result
PubMed Identifier
36067410
Citation
Bittner AK, Kaminski JE, Ross NC, Shepherd JD, Thoene SJ, Bui SZ, Yoshinaga PD; BeST-AID Study Team. Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision. Optom Vis Sci. 2022 Oct 1;99(10):743-749. doi: 10.1097/OPX.0000000000001944. Epub 2022 Sep 6.
Results Reference
result
Learn more about this trial
Beacon Sensors and Telerehabilitation for Low Vision
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