저시력 장치(BeST-AID) 사용을 평가하고 개선하기 위한 비콘 센서 및 원격 재활 (BeST-AID)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: UCLA Study Coordinator
- 전화번호: 310-794-5602
- 이메일: JessicaSLin@mednet.ucla.edu
연구 장소
-
-
California
-
Fullerton, California, 미국, 92831
- 아직 모집하지 않음
- Southern Califonia College of Optometry
-
연락하다:
- Patrick Yoshinaga, OD
-
Grass Valley, California, 미국, 95945
- 아직 모집하지 않음
- Chan Family Optometry
-
연락하다:
- Tiffany L Chan, OD
-
Los Angeles, California, 미국, 90095
- 모병
- UCLA Stein Eye Institute
-
연락하다:
- Ava K Bittner, OD, PhD
- 전화번호: 310-206-4649
-
수석 연구원:
- Ava K Bittner, OD, PhD
-
San Francisco, California, 미국, 94102
- 아직 모집하지 않음
- Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
-
연락하다:
- Tiffany Chan, OD
-
Santa Monica, California, 미국, 90401
- 아직 모집하지 않음
- See What You Miss Optometry
-
연락하다:
- Lynn Watt Kurata, OD
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- 아직 모집하지 않음
- New England College of Optometry
-
연락하다:
- Nicole C Ross, OD
-
Brockton, Massachusetts, 미국, 02301
- 아직 모집하지 않음
- Boston University Eye Associates, Inc.
-
연락하다:
- Lexi G Malkin, OD
-
-
Michigan
-
Midland, Michigan, 미국, 48640
- 아직 모집하지 않음
- Mid-Michigan Eye Care
-
연락하다:
- John E Kaminski, OD
-
-
Nebraska
-
Omaha, Nebraska, 미국, 68198
- 아직 모집하지 않음
- University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
-
연락하다:
- John Shepherd, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Activity Inventory
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MNread
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: baseline to 13 months
|
Bluetooth low energy beacon sensor data |
baseline to 13 months
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Ava K Bittner, OD, PhD, University of California, Los Angeles
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .