NCT06107881 Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
| NCT ID | NCT06107881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Low Vision |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2023-12-15 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Ava K Bittner, OD, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06107881 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Vision. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06107881 currently recruiting?
Yes, NCT06107881 is actively recruiting participants. Contact the research team at JessicaSLin@mednet.ucla.edu for enrollment information.
Where is the NCT06107881 trial being conducted?
This trial is being conducted at Fullerton, United States, Grass Valley, United States, Los Angeles, United States, San Francisco, United States and 5 additional locations.
Who is sponsoring the NCT06107881 clinical trial?
NCT06107881 is sponsored by University of California, Los Angeles. The principal investigator is Ava K Bittner, OD, PhD at University of California, Los Angeles. The trial plans to enroll 350 participants.