Beacon-sensorer og telerehabilitering for at vurdere og forbedre brugen af enheder (BeST-AID) til svagsyn (BeST-AID)
21. september 2026 opdateret af: Ava K. Bittner, OD, PhD, University of California, Los Angeles
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
350
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: UCLA Study Coordinator
- Telefonnummer: 310-794-5602
- E-mail: JessicaSLin@mednet.ucla.edu
Studiesteder
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California
-
Fullerton, California, Forenede Stater, 92831
- Ikke rekrutterer endnu
- Southern Califonia College of Optometry
-
Kontakt:
- Patrick Yoshinaga, OD
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Grass Valley, California, Forenede Stater, 95945
- Ikke rekrutterer endnu
- Chan Family Optometry
-
Kontakt:
- Tiffany L Chan, OD
-
Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Stein Eye Institute
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Kontakt:
- Ava K Bittner, OD, PhD
- Telefonnummer: 310-206-4649
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Ledende efterforsker:
- Ava K Bittner, OD, PhD
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San Francisco, California, Forenede Stater, 94102
- Ikke rekrutterer endnu
- Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
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Kontakt:
- Tiffany Chan, OD
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Santa Monica, California, Forenede Stater, 90401
- Ikke rekrutterer endnu
- See What You Miss Optometry
-
Kontakt:
- Lynn Watt Kurata, OD
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Ikke rekrutterer endnu
- New England College of Optometry
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Kontakt:
- Nicole C Ross, OD
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Brockton, Massachusetts, Forenede Stater, 02301
- Ikke rekrutterer endnu
- Boston University Eye Associates, Inc.
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Kontakt:
- Lexi G Malkin, OD
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Michigan
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Midland, Michigan, Forenede Stater, 48640
- Ikke rekrutterer endnu
- Mid-Michigan Eye Care
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Kontakt:
- John E Kaminski, OD
-
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Ikke rekrutterer endnu
- University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
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Kontakt:
- John Shepherd, MD
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Telerehabilitation with low vision provider
Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care |
Evaluation and training with magnification or visual assistive devices for visually-impaired adults |
|
Aktiv komparator: Usual Care In-Office
Low Vision Rehabilitation in-office for use of magnification or visual assistive devices |
Evaluation and training with magnification or visual assistive devices for visually-impaired adults |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Activity Inventory
Tidsramme: 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) |
changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MNread
Tidsramme: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
reading speed and acuity test |
baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
|
Sustained Silent Reading Test
Tidsramme: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
prolonged reading test |
baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
|
International Reading Speed Text (IReST)
Tidsramme: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
reading speed test |
baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
|
Radner Reading Charts
Tidsramme: baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
reading speed and acuity test |
baseline, 1 month, 4 months, 8 months, 12 months, 13 months
|
|
Vision rehabilitation satisfaction survey
Tidsramme: 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 |
after each session that will occur over a period of 1 to 8 months and and again at about 1 year
|
|
Informant surveys by close acquaintances of participants
Tidsramme: 4 months, 8 months, 12 months, 13 months
|
survey |
4 months, 8 months, 12 months, 13 months
|
|
Adherence to hand-held optical magnifier use (frequency and duration)
Tidsramme: baseline to 13 months
|
Bluetooth low energy beacon sensor data |
baseline to 13 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ava K Bittner, OD, PhD, University of California, Los Angeles
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- Bittner AK, Yoshinaga PD, Rittiphairoj T, Li T. Telerehabilitation for people with low vision. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD011019. doi: 10.1002/14651858.CD011019.pub4.
- Malkin AG, Ross NC, Chun MW, Bittner AK; CARE Study Team. Why Are Visual Assistive Mobile Applications Underused by Low Vision Patients? Optom Vis Sci. 2022 Apr 1;99(4):333-334. doi: 10.1097/OPX.0000000000001893. No abstract available.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2023
Primær færdiggørelse (Anslået)
30. juni 2028
Studieafslutning (Anslået)
30. juni 2028
Datoer for studieregistrering
Først indsendt
18. oktober 2023
Først indsendt, der opfyldte QC-kriterier
24. oktober 2023
Først opslået (Faktiske)
30. oktober 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BeST-AID 2.0
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Please contact the principal investigator
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .