Studies involving telerehabilitation were conducted in three phases spanning a 7-year period during the years of 2016–2022: phase 1 in 2016–2017, phase 2 in 2018–2019, and phase 3 in 2020–2022. Phase 1 (pilot) was a prospective cohort pilot study that connected participants in their homes to the telerehabilitation videoconference session via guidance from the principal investigator by phone,
12 phase 2 (Lions) incorporated assistance from community Lions Club members who set up the telerehabilitation sessions in participants’ homes, and phase 3 (RCT) was a randomized controlled trial in which participants were randomized to two groups utilizing a 2:1 allocation ratio to evaluate telerehabilitation services in the home versus in-office vision rehabilitation as the usual care control group. Participants in all three phases were adults aged 18+ years who had newly received portable electronic video, handheld, or stand optical magnifiers; multiple devices were allowed. Each participant was involved in only a single phase and did not participate in more than one of our studies of telerehabilitation. Thus, each participant represents an unique telerehabilitation encounter. Phase 1 (pilot) included 10 participants;
12 phase 2 (Lions) included 11 subjects, with 9 participants in a prospective cohort study and 2 participants from the RCT; and phase 3 (RCT) compared 24 participants in the telerehabilitation group to 13 usual-care control group participants who received magnifier training in office (without telerehabilitation). All causes of visual impairment were included in all phases. Exclusion criteria for all three phases were medical or self-reported history of cognitive impairment, non-English speaking, or no access to a home telephone. Participants with mild to moderate hearing impairment were included in the study, while those who were unable to consistently hear the clinical provider during the initial in-office dispense for the magnifier due to severe hearing loss were not recruited. Phase 3 (RCT) further defined exclusion for cognitive impairment as a raw score of less than 20 on the Telephone Interview for Cognitive Impairment,
15 which was administered at time of study enrollment. Participants in all three phases had an in-office vision rehabilitation assessment before study enrollment and received a new magnifier prescribed by the vision rehabilitation provider, at which time they all received initial in-office training with the new magnifier. Prescriptions to obtain or update the participants’ distance and/or near spectacle correction were also issued at the initial office visit when appropriate. Best-corrected visual acuities (BCVAs) were measured at distance with either an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart or Snellen chart (then converted to logMAR values) and at near with a continuous text reading card or the MNread test.
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Across all study phases, participants were recruited from vision rehabilitation clinical practices, which included both academic institutions and private practices. Phase 1 included four recruiting sites: (1) New England College of Optometry (NECO) in Boston, Massachusetts; (2) University of Nebraska Medical Center (UNMC) in Omaha, Nebraska; (3) Alphapointe in Kansas City, Missouri; and (4) Southern California College of Optometry (SCCO) in Fullerton, California. Phase 2 included participants from two sites: (1) Nova Southeastern University, College of Optometry (NSUCO) in Ft. Lauderdale, Florida, and (2) Mid-Michigan Eye Care, a private practice in Midland, Michigan. Phase 3 included eight sites: (1) NECO; (2) UNMC; (3) SCCO; (4) Mid-Michigan Eye Care; (5) Low Vision Services in Alexandria, Virginia; (6) Frank Stein & Paul S. May Center for Low Vision Rehabilitation in San Francisco, California; (7) Boston University Eye Associates in Brockton, Massachusetts; and (8) University of California, Los Angeles (UCLA), Stein Eye Institute. The providers for the vision rehabilitation training were optometrists at seven sites and three occupational therapists at UNMC, Alphapointe, and the San Francisco site.
For phases 1 and 2, the study protocol was approved by the institutional review boards at Nova Southeastern University and NECO. For phases 2 and 3, the study protocol was approved by the institutional review board at UCLA. All study protocols followed the tenets of the Declaration of Helsinki. All participants provided oral informed consent by phone during all phases. The study protocol was listed on clinicaltrials.gov (Identifier: NCT04066075).
For telerehabilitation during all three phases, a kit with loaner equipment was provided at the time of the session or shipped in advance of the telerehabilitation session. Participants used the loaner devices to access the session, rather than their own Internet-enabled device.
Table 1 lists the loaner equipment used in each phase, which varied across phases for the type of Internet-enabled device; that is, phase 1 provided a Verizon MiFi 4G LTE mobile hotspot (model 6620 L Jetpack; Verizon Wireless, New York, NY, USA) with tablets (9.7-in. Onda V919 [Onda Electronics, Guangzhou, China] and/or 7-in. Vido T99 [Vido Digital Electronics Co. Ltd., Shenzhen, China] with Android operating system) and/or iPad mini (Apple Corporation, Cupertino, CA, USA), while phase 2 used a Verizon data-enabled iPad mini or Samsung Galaxy S6 smartphone, and phase 3 used only a Verizon cellular data–enabled Samsung Galaxy S6 smartphone. An external speaker was utilized for some of the phase 1 participants but not in phase 2 or 3. All three study phases included the same stand for the tablet or smartphone and the same standardized near acuity cards (i.e., MNread charts and Lighthouse continuous text) to assess participants’ reading with their magnifier. Photocopies of the near cards were provided in sealed envelopes with instruction to open only during the session. We used videoconference services from Zoom.us for all three study phases.
Table 1 lists the type of assistance for accessing the Zoom videoconference platform, which also varied across the study phases. For phase 1 (pilot), the study principal investigator (AKB) contacted the participant and/or a normally sighted companion by phone about an hour before the scheduled telerehabilitation session time, to guide them through the setup process and help with any issues related to accessing the Zoom videoconference portal. Additionally in phase 1, the loaner kit included a hard-copy, large-print manual with a step-by-step list of instructions and photos of how to connect to the session. In phase 1, 70% of participants were assisted by normally sighted family members or acquaintances. Due to challenges that participants experienced with technology in phase 1,
14 we subsequently recruited local Lions Club members for phase 2. They were trained to bring the loaner equipment to the participant's home and set up the session to reduce the burden of the technology for visually impaired participants. Phase 3 (RCT) required changes to this protocol due to the COVID-19 pandemic when we were unable to have Lions volunteers in participants’ homes. Thus, phase 3 involved the use of remote access control software (RescueAssist by LogMeIn, Inc., Boston, MA, USA) on our loaner smartphones that enabled the study principal investigator (AKB) to remotely connect the participant to the Zoom videoconferencing session after confirming by phone that they were ready. Phase 3 participants only needed to turn on the loaner smartphone and place it in the loaner stand during the session. Phases 2 and 3 did not require normally sighted family members or acquaintances to be involved in the setup of the telerehabilitation sessions.
Across all phases, after the initial in-office training with the new magnifier at the time of its dispense, participants used it at home and during daily activities for at least a month before telerehabilitation or the in-office visit for additional training was scheduled. Participants were eligible for telerehabilitation or additional in-office training session 1 to 4 months after the magnifier was dispensed; most participants received this additional training 1 to 2 months after they obtained the magnifier. A standard protocol for the interaction between the vision rehabilitation provider and the participant during the telerehabilitation encounter was utilized consistently across all three study phases for the training sessions with magnifiers. Telerehabilitation sessions took place in participants’ homes with the provider in office and typically lasted about an hour. The duration of the session was consistent across all study phases, and a second or third session was scheduled after the hourlong session in phase 3 (RCT) if needed, based on the participant's needs. We asked all participants to set up the loaner equipment in the place where they do most of their reading with their magnifier in their home. The provider evaluated the participant's technique with their magnifier (i.e., working distance, viewing angle, lighting) and their reading fluency (i.e., speed, accuracy, and print size) while using the Lighthouse continuous text card and MNRead test, followed by their own reading materials of interest. Individualized magnifier training was provided to each participant, based on their needs with the device. Generally, the training strategy involved verbal instructions from the provider to make any necessary adjustments to the placement of the magnifier and/or reading material, including feedback on the working distance, viewing angle, movement of the magnifier, and/or level of zoom (i.e., for portable electronic devices) to obtain the best magnification and field of view while reading continuous text. If relevant, the providers asked participants to demonstrate how to change the battery in the magnifier. For phase 3 (RCT), 13 participants in the usual-care control group received training in office with their provider, instead of telerehabilitation for new portable electronic video, handheld, or stand optical magnifiers. For the in-office sessions, the providers administered the same standardized reading tests and gave training to optimize magnifier usage, as in the telerehabilitation protocol.
Participants in all three study phases completed the same satisfaction survey to give feedback on the telerehabilitation session using multiple-choice rating scales. The survey questions are included as
Supplementary Material. Participants in the RCT who were in the in-office usual-care group completed the satisfaction survey items that were relevant to the training they received. During phase 3 (RCT), we inquired about whether participants had hearing loss or nonvisual physical disability during the survey. All surveys were administered to participants by research assistants at NSUCO (phases 1 and 2) or UCLA (phases 2 and 3) who called the participant by phone within 1 week following the telerehabilitation or in-office session. Each participant had only one telerehabilitation session in phase 1 (pilot) and phase 2 (Lions), while up to three sessions were scheduled within a 3-month period in phase 3 (RCT) (mean of 1.8 sessions across participants). We only included the survey responses for the initial session in phase 3 for comparison to phases 1 and 2.