Study design

This feasibility study considered the Consolidated Standards of Reporting Trials guideline components,27 and is a parallel two-arm randomised study consisting of training individuals with LV in the use of eSight Eyewear when engaging in activities of daily living. The experimental intervention will entail a series of personalised LV telerehabilitation sessions with a LV rehabilitation specialist. The control intervention will consist of the conventional eSight self-training using their eSkills User Guide28 as well as optional access to standard support available through eSight Corporation staff. These staff members may either be normally sighted, or may be device users whose experience is based on their own visual impairment. The study will be based at the School of Optometry of the Université de Montréal, Montreal, Quebec, Canada, and follows the requirements of the Declaration of Helsinki for conducting research with human participants.29

Telerehabilitation equipment

In the case of personalised training by telerehabilitation, participants will benefit from distance training sessions delivered to their home via the Internet with a LV therapist at the School of Optometry of the Université de Montréal. Each participant will be able to interact in real time, using a secure and password-protected connection, with the LV therapist using the REACTS telehealth platform, accessible from their computer or digital tablet at specific appointments (https://www.iitreacts.com).

We will include individuals with self-reported LV aged 18+ years, who are able to communicate in English or French, have a tablet, desktop or laptop computer with internet access, are highly motivated to participate in the study, and recently (<1 month) bought or are currently renting an eSight Eyewear device. Current device users who have owned their eSight device for >1 month (and have therefore completed the eSight eSkills User Guide), as well as those self-reporting other severe sensory impairments that may interfere with communication, will be excluded. The LV therapist will confirm whether participants are able to follow a 20 min phone conversation (ie, sufficient hearing and cognition to complete oral informed consent and protocol procedures by phone, based on her clinical experience), and will exclude them if comprehension and/or communication are challenged. Figure 1 summarises the design of the study; each of the study aspects is described in detail.

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Figure 1

Flowchart showing planned participant flow.

Interventions

Self-training standard provided by eSight. This intervention focuses on the technical aspect of using the eSight device, namely: ‘how does eSight Eyewear work?’. All participants in the control group will receive the eSkills learning and training guide28 as usually provided when purchasing the device. This guide is a self-training programme that spans 1 hour per day for 1 month (30 hours) to be performed self-guided at home, and divided into 4 weeks of exercises (see table 1). At the end of the training, the participants will continue to use the eSight Eyewear in their environment until the end of the study 5 months later (and beyond).

Personalised training through telerehabilitation. This intervention focuses on the functional aspect of using eSight, namely: ‘How to achieve your activities of daily living with eSight Eyewear?’. The personalised training by telerehabilitation will be provided by the same and only LV therapist involved in the study and will consist of six 1 hour online training sessions within the first 2 weeks (6 hours), 12 additional hours of homework in parallel during the same 2 weeks and an additional 12 hours of homework in the following 2 weeks. The LV therapist and participants will share common work materials composed of exercises that they can easily refer to. The materials are composed of the eSkills learning and training guide28 and digitised exercises extracted from the VisExc—eccentric fixation programme30 (partially adapted from the McGill Low Vision Manual,31 sent by email for eccentric fixation training). The 6 sessions will be scheduled at the beginning of the study according to the participants’ and the LV therapist’s availabilities (see table 2). Individualised training in the use of the eSight Eyewear will be provided to each participant and tailored to the needs of each person, as would be the case in face-to-face clinical practice.

At each session, a 5 min break will be offered to participants when needed. Between each of these 6 sessions, participants are asked to continue to train themselves at home using the eSkills learning and training guide for ~6 hours per week (12 hours of homework). At the end of the 2 weeks (telerehabilitation intervention), the participants will continue their training for 2 weeks (12 hours of homework remaining) and continue using their eSight device at home, until the end of the study 5 months later (and beyond).

Outcomes

The primary outcome of this study is related to the feasibility of telerehabilitation in the context of eSight Eyewear users and encompasses several measures: (1) enrolment target (signed consent) within 10 months, (2) retention of participants until 6 months after randomisation, (3) accessibility of telerehabilitation training and (4) acceptability of telerehabilitation training.

Primary outcomes

Considering the feasibility aspect of the study, our enrolment target is 60 participants (30 renters and 30 buyers of eSight Eyewear) over 10 months. We will consider that a trial is feasible if we enrol 80% of this figure (n=54) during this period and/or if 100% are enrolled over 12 months. We will record the number of eligible individuals declining to participate and why, and capture whether any participants dropped out of the study and why. Retention will be monitored by follow-up evaluations and through questionnaires. Accessibility of the training via telerehabilitation will be determined by asking participants and the LV therapist independently about any problems related to internet connectivity, access to the videoconference platform, use of the hardware and audio/visual quality. At each training session, the LV therapist will report any problems in a diary, for each participant and herself, respectively. Regarding acceptability, all participants and the LV therapist will complete a satisfaction survey with a research assistant, containing quantitative and qualitative items, to indicate their preferences regarding the telerehabilitation intervention or the self-training programme, as well as to report barriers and facilitators. Participants will be asked to rate the experience of telerehabilitation or self-training for comfort, efficiency, effectiveness and likelihood for future use, rated on a 4-point Likert scale (‘strongly agree’ to ‘strongly disagree’). The LV therapist will be asked to provide her overall perception and judgement of the telerehabilitation compared with her previous experience with face-to-face intervention (in-office sessions and/or home visits). In addition, we will ask participants for their written permission (consent form to be provided by mail) to contact their eye care professional to obtain an eye report, including visual information (ie, visual acuities, diagnosis).

Exploratory/secondary outcomes

In addition to the primary outcomes, we will collect measures about the impact of telerehabilitation on use behaviour (eSight Eyewear discontinuance rate) and on participants’ quality of life (measured with two standardised device-related quality of life questionnaires, described in the Exploratory/secondary outcomes section). We will explore important predictors of eSight Eyewear use pre-identified in a cross-sectional study,16 such as the presence of headaches, follow-up service satisfaction, and other people’s reaction while participants use their eSight device.

Discontinued device use will be monitored by follow-up evaluations and through questionnaires. In the context of our analyses, early discontinuance in device use is defined as a participant who stops using the device during the first 2 weeks of the study (either a renter who decides not to buy the device at the end of the rental period or a buyer who decides not to use it anymore), because this is the time period during which eSight Corporation offers a loan to customers. From a clinical research point of view, we will define discontinuance in device use as a participant reporting non-use of the device in the previous 3 months on any given task, as it has previously been applied in the context of LV devices in an outpatient population32 and as reported in a questionnaire specifically developed for this study, containing open and closed questions.

We will measure the impact of assistive technology on quality of life in a standardised and objective way with the Psychosocial Impact of Assistive Devices questionnaire (PIADS)33–35 and the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST),36 37 both of which are validated in English and French. The PIADS is a 26-item questionnaire originally developed to measure the effect of assistive devices on quality of life and was pilot-tested with eyeglasses and contact lenses.35 The PIADS has previously been used with LV magnification devices, specifically with CCTVs.38 39 It is a reliable and valid tool and can predict assistive technology abandonment.33 35 There are three subscales: competence, adaptability and self-esteem. The QUEST)37 is a 12-item outcome measure that assesses user satisfaction with two components, device and services, with a wide range of assistive technology in a structured and standardised way. Psychometric properties have been tested with respect to test–retest stability, alternate-form equivalence, internal consistency and factorial composition validity, and appear to be adequate.37 Device dimension embraces eight items related to salient characteristics of the assistive technology whereas the services dimension encompasses four intercorrelated items.

To explore factors related to the use and discontinuance of use of the device in connection with using eSight, a questionnaire was specifically developed. It employs open and closed questions whose items refer to timing and frequency of use, nature of the task for which the device is used or discontinued. It is composed of 40 items, examining the use of eSight, user’s characteristics, utilisation changes, social and physical environments and training/intervention.

Participation timeline

Each participant will be engaged in the study anywhere between 2 weeks (renters who choose not to purchase) and 6 months (buyers, and initial renter deciding to buy eSight Eyewear after the trial period) starting at randomisation, with assessments at baseline, 2 weeks, 3 and 6 months. After their recruitment, participants will be contacted by phone about an hour before the scheduled telerehabilitation session time, to guide them through the setup process and help with any questions or issues related to accessing the videoconference portal. An initial questionnaire (∼30 min), administered by the LV therapist, will be used to collect data on demographics, health conditions and quality of life. Then, a second questionnaire (∼45 min), will be used for the three follow-up assessments. This questionnaire is composed of 94 questions adopted from the PIADS and the QUEST, and questions specifically developed for this study, and will be self-administered online, accessible through a URL link. The schedule of assessments is summarised in table 3. This survey has been pilot-tested with four individuals, one with normal sight to confirm content consistency and general accessibility, followed by three individuals with visual impairment to confirm accessibility with technologies, two using ZoomText magnification software and one with JAWS screen reading software.

Sample size

A previous clinical trial using eSight Eyewear reported recruiting 74 individuals across 6 sites, of which 51 completed the study (drop-out rate of 31%)13; however, a key difference was that the investigators provided eSight Eyewear as a loan for the period of the 3-month study, and participants were not self-selected device owners/renter, as is the case in the present study. Therefore, without direct comparison standard, we will recruit 60 participants in total, with 30 individuals in each group. This sample size is comparable to other feasibility studies in LV rehabilitation40 and is intended to maximise the available data given the opportunity created through the collaboration with the device manufacturer. Given the proposed recruitment period, this sample size will allow us to evaluate any possible limitations with enrolment and retention more robustly, and will provide rich data on accessibility and acceptability of a telerehabilitation training. A previous multicentre prospective study demonstrating the short and medium term effects of eSight Eyewear, reported various effect sizes that cover the secondary outcome measures proposed in the present protocol, ranging from ω ² =0.04 to 0.83. Choosing a conservative average effect size of ω ² =0.23 to calculate the sample of the present study (based on a mixed design ANOVA), power analysis using G*Power41 42 indicated that, with a desired power of 0.95 and alpha level of 0.05, the necessary sample size is n=60, with n=30 in each arm, a sample size commonly used in feasibility studies.

Recruitment

The projected study timeline is from September 2018 to December 2019. Directly after buying or renting an eSight device, clients will be informed by an employee of eSight Corporation of the opportunity of participate in the present research project. A letter introducing the study will be sent by email at the time of device delivery, and a paper version will be added in the parcel, providing the contact information of the research team to the users, so they can express their interest in participation. Once a person has expressed an interest, the LV therapist will provide verbal (by phone) and written (outline of the study and consent form will be sent by email to the potential participant) study information, explaining the objectives and the schedule of the study, will check eligibility and obtain informed written consent. Potential participants will be asked to sign, scan/photograph and return their consent form by email.

Assignment of interventions

Participants will be randomised to receive either personalised LV training by telerehabilitation, or the self-training standard provided by eSight. Allocation will be at a 1:1 ratio, whereby two randomisations will be carried out separately at the Université de Montréal by a research assistant who is not involved in the study: one for the participants who bought the eSight Eyewear, the other for those who rented them. Given the small samples sizes, and in order not to take the risk of having unbalanced control and experimental groups, the first participant of each group will be allocated by coin toss, and then allocation of all following participants will alternate. The LV therapist is only notified of group allocation at the first testing session.

Bias control

Both participants and the LV therapist administering the protocol will be aware to which condition (control or experimental) the participants are allocated. Therefore, in order to minimise experimenter bias, we will use online follow-up questionnaires via an URL link (https://www.hostedincanadasurveys.ca).

Data collection, management and analysis

Data collection and data management. Participants will be assigned a study number after consent prior to randomisation. Quantitative data will be tabulated using a Microsoft Office Excel spreadsheet. Interview data will be audio recorded and transcribed verbatim into a Microsoft Office Word document. All data will be analysed by the study principal investigator (M-CL), who will not meet the participants or be involved in data collection and will be masked to group membership until data collection is complete in order to reduce detection bias. Data will be stored centrally and kept in locked, secure access filing cabinets or on password-protected computers on Université de Montréal premises; this includes electronic data and case report forms and interview materials. These data will be stored for a period of 7 years until the end of the project, after which they will be destroyed.

Statistical analyses

Data will be analysed using JASP V.0.9 software.43 The analysis plan consists of 3 steps. In step 1, descriptive statistics will be used to present the sample and responses on all outcome measures. In step 2, we will examine the primary outcome measures to evaluate feasibility, including recruitment, retention, accessibility and acceptability, while in step 3, we will explore possible effects within the secondary outcomes, including device abandonment and quality of life.

Step 1: descriptive measures, including participants’ demographic and clinical characteristics, will be summarised as means and SD, medians and IQRs, and by counts and percentages as appropriate.

Step 2: enrolment will be analysed using the period of recruitment defined (from September 2018 to June 2019), reporting the number of participants assessed for eligibility and the number of participants who will be excluded (number of participants declining to participate and number of participants not meeting the inclusion criteria). We will report the number of participants who will be enrolled within the 10-month recruitment period and whether the minimum required 80% (54 participants) were reached.

Retention in both the experimental and the control groups will be analysed at 2 weeks, as well as 3 and 6 months using the number of participants remaining in the study. If participants wish to withdraw after they have been allocated to an intervention group, we will give them the opportunity to explain their reasoning, should they be interested in sharing these reasons and will record them in the case report.

Accessibility of telerehabilitation training (numbers and types of issues with: Internet connectivity, access to the videoconference platform, use of the hardware and audio/visual quality) will be presented as frequency counts as well as analysed using qualitative description.44

Acceptability will be measured using quantitative (satisfaction surveys) and qualitative measures (interview with the LV therapist). Quantitative measures (ordinal data) will be presented using descriptive statistics. Qualitative analysis will reveal barriers and facilitators related to telerehabilitation intervention. An interview with the LV therapist will be transcribed verbatim and coded by the first author and a research assistant, using a case study approach, starting with open coding.45 Significant sentences in each transcript that have relevance to the research question to help us better understand barriers and facilitators to the telerehabilitation intervention with eSight users, as experienced by the LV therapist, will be highlighted.46 Then, all codes will be grouped together according to common themes. Coding disagreements will be resolved in face-to-face discussion, and any remaining disagreement will be decided by a third party (WW). Finally, the codes will be grouped into themes to establish an overall descriptive picture of the interview content that allows the reader to better understand the barriers and facilitators related to this telerehabilitation intervention.47

Step 3: secondary outcomes. (1) eSight Eyewear early discontinuance rate at 2 weeks and discontinuance rate at 6 months will be analysed using descriptive statistics. (2) Quality of life as measured by the PIADS and QUEST will be examined according to a factorial design approach (see figure 1), comparing outcomes for device renters with those of device owners; in addition, participants who are in the control group will be compared with those in the intervention group, both across follow-up time points (pre-intervention, after 2 weeks, as well after 3 and 6 months of device use). Given the repeated-measures component of the study, and in order to accommodate potentially missing data, the analyses will be conducted using a mixed-effects model, and post-hoc tests using Tukey's honestly significant difference correction. (3) Factors preidentified as being predictive of eSight, depending on the nature of the 40 items questionnaire, Spearman correlation coefficients and χ² will be calculated to examine the relationships between ordinal (eg, quality of life score) and categorical (eg, discontinuation frequency) variables, respectively. Data collected up to the point of withdraw will be included in the data analysis.

Study status

Recruitment and data collection are currently ongoing. Recruitment is expected to be completed in June 2019, given minor delays in the timeline. Data collection is expected to be complete in December 2019, followed by data analyses and manuscript preparation in early 2020.

Patient and public involvement

The research questions and outcome measures of the present study were tailored to reflect the barriers and facilitators to eSight Eyewear use as identified by device users in a cross-sectional study.16 It is planned, once the telerehabilitation intervention is completed, to ask participants to assess the burden of the telerehabilitation intervention and the time required to participate, in order to design future interventions to accommodate accordingly.

Limitations and possible solutions

A limitation in our study is self-selection bias, as we will enrol participants who spontaneously decide to rent or purchase eSight Eyewear, express interest in research participation, own the computer equipment necessary for telerehabilitation and data collection, and are willing to try an Internet-based video conference platform. To overcome this potential bias, we plan to loan eSight Eyewear and tablets to participants in the next phase of this project.

Another limitation is that it will not always be possible to differentiate all possible reasons for discontinuance versus drop-out or other types of attrition. This will probably be the case specifically for participants lost to follow-up without explanation. However, through regular monitoring throughout the study, we hope to be able to record most reasons for leaving the study. Another potential limitation is the absence of an in-office evaluation with objective visual function measures, such as visual acuity, visual field or contrast sensitivity, which could provide complementary insight. Given the online survey nature of data collection, complete access to medical chart information will not be feasible. However, we will be able to obtain some objective information about visual function by asking participants to give the research team access to their most recent eye report.

The results of this study will be presented at local, national and international conferences that cater to LV rehabilitation professionals and researchers, and will be published in a peer-reviewed research journal. It is also planned to publish an article in a journal that is more focused on clinical outcomes in vision rehabilitation or on assistive technology.