Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
- Conditions
- Low VisionLow Vision Aids
- Interventions
- Behavioral: Low Vision Rehabilitation
- Registration Number
- NCT06107881
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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.
- 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 1"x1" to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care In-Office Low Vision Rehabilitation Low Vision Rehabilitation in-office for use of magnification or visual assistive devices Telerehabilitation with low vision provider Low Vision Rehabilitation Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care
- Primary Outcome Measures
Name Time Method Activity Inventory changes from 1 month to 4 months to 8 months to 12 months to 13 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
Name Time Method MNread baseline, 1 month, 4 months, 8 months, 12 months, 13 months reading speed and acuity test
Sustained Silent Reading Test baseline, 1 month, 4 months, 8 months, 12 months, 13 months prolonged reading test
International Reading Speed Text (IReST) baseline, 1 month, 4 months, 8 months, 12 months, 13 months reading speed test
Adherence to hand-held optical magnifier use (frequency and duration) baseline to 13 months Bluetooth low energy beacon sensor data
Radner Reading Charts baseline, 1 month, 4 months, 8 months, 12 months, 13 months reading speed and acuity test
Informant surveys by close acquaintances of participants 4 months, 8 months, 12 months, 13 months survey
Vision rehabilitation satisfaction survey after each session that will occur over a period of 1 to 8 months and and again at about 1 year surveys: post-telerehabilitation or in-office visits
Trial Locations
- Locations (10)
Southern Califonia College of Optometry
🇺🇸Fullerton, California, United States
New England College of Optometry
🇺🇸Boston, Massachusetts, United States
University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
🇺🇸Omaha, Nebraska, United States
Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
🇺🇸San Francisco, California, United States
Chan Family Optometry
🇺🇸Grass Valley, California, United States
UCLA Stein Eye Institute
🇺🇸Los Angeles, California, United States
Boston University Eye Associates, Inc.
🇺🇸Brockton, Massachusetts, United States
See What You Miss Optometry
🇺🇸Santa Monica, California, United States
Mid-Michigan Eye Care
🇺🇸Midland, Michigan, United States
Low Vision Services, PLC: Low Vision Learning Center
🇺🇸Alexandria, Virginia, United States