Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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),
Trial design
Design model
Parallel
Treatments tested in this trial
Low Vision Rehabilitation
BehavioralEvaluation and training with magnification or visual assistive devices for visually-impaired adults
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Telerehabilitation with low vision providerExperimental treatment 1 intervention
Group B: Usual Care In-OfficeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Activity Inventory
questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
Time frame
changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification deviceSecondary outcomes
1
MNread
reading speed and acuity test
Time frame
baseline, 1 month, 4 months, 8 months, 12 months, 13 months2
Sustained Silent Reading Test
prolonged reading test
Time frame
baseline, 1 month, 4 months, 8 months, 12 months, 13 months3
International Reading Speed Text (IReST)
reading speed test
Time frame
baseline, 1 month, 4 months, 8 months, 12 months, 13 months4
Radner Reading Charts
reading speed and acuity test
Time frame
baseline, 1 month, 4 months, 8 months, 12 months, 13 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
University of Nebraska
Collaborator
New England College of Optometry
Collaborator
Southern California College of Optometry at Marshall B. Ketchum University
Collaborator
Mid-Michigan Eye Care
Collaborator
Source ClinicalTrials.gov