Last reviewed · How we verify

NCT04066075: BeST-AID

Beacon Sensors and Telerehabilitation for Low Vision

Completed NA Results posted Last updated 29 June 2025
What this trial tests

NA trial testing Low Vision Rehabilitation in Low Vision in 61 participants. Completed in 28 November 2023.

Timeline
10 October 2019
Primary endpoint
28 November 2023
28 November 2023

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment61
Start date10 October 2019
Primary completion28 November 2023
Estimated completion28 November 2023
Sites11 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Low Vision. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Activity Inventory Primary · change from 1 month to 4 months after receiving a magnification device

change in the 'Activity Inventory' questionnaire; scores for reading ability were Rasch analyzed in logit units with higher or positive scores indicating less difficulty (i.e., improvement)(Higher values represent a better outcome/ability). Range of changes from 1 month to 4 months after receiving a magnification device were -2.06 to 2.59.

GroupValue95% CI
Telerehabilitation With Low Vision Provider0.440.08 – 0.80
Usual Care (Active Control)0.430.15 – 0.71
MNread Test of Reading Acuity Secondary · between 1 month and 4 months

change in reading test measured during the telerehabilitation sessions for participants who completed the MNread at two telerehabilitation sessions to indicate their reading acuity (smallest size read in logMAR units)

GroupValue95% CI
Telerehabilitation With Low Vision Provider0.080.001 – 0.16
Geriatric Depression Scale (GDS) Secondary · baseline, 4 months

change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

GroupValue95% CI
Telerehabilitation With Low Vision Provider-0.14-1.18 – 0.89
Usual Care (Active Control)1.11-0.29 – 2.52
Hospital Anxiety & Depression Scale Secondary · baseline, 4 months

change in questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety

Depression
GroupValue95% CI
Telerehabilitation With Low Vision Provider-0.29-1.16 – 0.59
Usual Care (Active Control)0.22-1.04 – 1.48
Anxiety
GroupValue95% CI
Telerehabilitation With Low Vision Provider-0.50-1.42 – 0.42
Usual Care (Active Control)0.72-0.63 – 1.74
MNread Test of Reading Speed Secondary · between 1 month and 4 months

change in reading test measured during the telerehabilitation sessions for participants who completed the MNread at two telerehabilitation sessions to indicate their log reading speed measured as words per minute.

GroupValue95% CI
Telerehabilitation With Low Vision Provider0.180.06 – 0.29

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Environmental and behavioural interventions for reducing physical activity limitation and preventing falls in older people with visual impairment.
    E JY, Li T, McInally L, Thomson K, et al · · 2020 · cited 19× · PMID 32885841 · DOI 10.1002/14651858.cd009233.pub3
  2. Telerehabilitation for people with low vision.
    Bittner AK, Yoshinaga PD, Rittiphairoj T, Li T. · · 2023 · cited 10× · PMID 36637057 · DOI 10.1002/14651858.cd011019.pub4
  3. Acceptability of Telerehabilitation for Magnification Devices for the Visually Impaired Using Various Approaches to Facilitate Accessibility.
    Bittner AK, Yoshinaga PD, Shepherd JD, Kaminski JE, et al · · 2022 · cited 8× · PMID 35917136 · DOI 10.1167/tvst.11.8.4
  4. Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision.
    Bittner AK, Kaminski JE, Ross NC, Shepherd JD, et al · · 2022 · cited 7× · PMID 36067410 · DOI 10.1097/opx.0000000000001944
  5. Outcomes of Telerehabilitation Versus In-Office Training With Magnification Devices for Low Vision: A Randomized Controlled Trial.
    Bittner AK, Kaminski JE, Yoshinaga PD, Shepherd JD, et al · · 2024 · cited 5× · PMID 38214688 · DOI 10.1167/tvst.13.1.6
  6. Value of Handheld Optical Illuminated Magnifiers for Sustained Silent Reading by Visually Impaired Adults.
    Kaminski JE, Yoshinaga PD, Chun MW, Yu M, et al · · 2023 · cited 3× · PMID 36951854 · DOI 10.1097/opx.0000000000002013
  7. Bluetooth Low Energy Beacon Sensors to Document Handheld Magnifier Use at Home by People with Low Vision.
    Bittner AK, Estabrook M, Dennis N. · · 2021 · PMID 34770374 · DOI 10.3390/s21217065

Verify or expand the search:

Other trials of Low Vision Rehabilitation

Trials testing the same drug.

Other recruiting trials for Low Vision

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04066075.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing