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JMIR RESEARCH PROTOCOLSactivities of daily living may be present as a result of either orboth conditions.Low Vision Makes Reading More EffortfulThe Framework for Understanding Effortful Listening has beenused to illustrate how listeners with a hearing impairmentallocate more cognitive resources in challenging conditions(such as when an individual has hearing loss or there is noise)[33]. Similarly, reading becomes more effortful in the presenceof central visual impairment or when visual input is suboptimal.For example, AMD generally causes a reduction in visual acuity,making it necessary for persons living with AMD to utilizemagnification in order to read with peripheral retina that is stillintact [34,35]. Given that fixation in the periphery is less stable[36], more concentration and effort are required to readmagnified text with a peripheral retinal locus [37,38]. Effortfulviewing or reading explains why the presence of central visualimpairment (eg, the presence of central scotoma and resultingdrop in visual acuity) has repeatedly been correlated withreduced reading speed as low as 20-40 words per minute [39],whereby poorer fixation stability has been associated withslower reading speeds [40]. Increased cognitive load leads to adecrease in the attentional visual window [41]. As individualswith vision loss find reading more effortful, thus experiencinga higher cognitive load, their attentional window should shrink.Processing of visual information in the retinal periphery (as isnecessary in persons living with AMD) is slower and not asefficient as in the macular region [42], in both younger and olderobservers [43]. In addition, low vision affects eye movementsduring reading, thereby further shrinking the perceptual windowwhere letters are processed, likely due to the increase incognitive demand [44]. Importantly, when some cognitiveresources are diverted to this reading effort, remaining cognitiveresources may be insufficient for readers to rapidly or accuratelyprocess (comprehend or remember) the information that wasseen or read.Low Vision Rehabilitation Reduces Reading EffortDifficulty while reading is the most common functionalcomplaint in persons with low vision, and improving the abilityto read is often the main purpose of vision rehabilitationinterventions [45]. The effectiveness of low vision rehabilitationhas been demonstrated repeatedly [46,47], specifically forreading [48]. A systematic review confirmed that there is strongevidence that low vision reading rehabilitation services improvereading ability overall [49]. Both magnification devices (eg,handheld magnifiers, closed-circuit televisions, or zoomfunctions on an iPad [50,51]) and large print appear to be equallyeffective [52]. Increasing reading performance (eg, increasingreading speed at decreased print size or improvingcomprehension) is frequently the main target for improvementduring rehabilitation [49,53]. It has been used as the primaryoutcome measure in recent clinical trials demonstrating theeffectiveness of low vision treatments [49,53]. Individuals livingwith low vision can be trained to use either closed-circuittelevision video magnifiers or mechanical magnification devices(eg, handheld magnifiers, telescopes) to help improve readingperformance by up to 200% [54]. One central underlying goalof low vision rehabilitation is to reduce the effort that is 19931XSL FORenderXWittich et alto accomplish visual tasks in the presence of a visual impairment[55]. Measuring this effort (or its reduction) can be donesubjectively by asking participants whether they perceive lesseffort during completion of the task. However, there are also avariety of observable variables that can be used as indicators ofreduced reading effort. They include improved reading speed(eg, reading becomes faster as it becomes easier) and improvedreading comprehension (eg, less effort liberates cognitiveresources for processing and retention [33]). Interestingly, thefindings for reading comprehension in the presence of low visionare mixed [56] insofar as reading speed (as an indicator ofeffort), scotoma size, and visual acuity all influencecomprehension. However, most studies on low vision readinghave small sample sizes and are underpowered. Therefore, it ishard to control for factors such as scotoma size or acuityimpairment, a problem we hope to overcome in our study byrecruiting a larger number of participants than is generally thecase in studies on low vision and reading.The Link Between Reading and CognitionReading is a complex process that involves bottom-up visualprocessing to enable grapheme (ie, letter) recognition that inturn enables grapheme-to-phoneme conversion, leading to wordrecognition and the identification of morphosemantic, syntactic,and pragmatic features of lexical items that are ultimately usedin the comprehension of sentences and discourse such as stories[57]. Because reading is subserved by a number of cognitiveprocesses, including attention, long-term memory, and workingmemory, there is a symbiotic relationship between reading andcognitive processing as has been documented extensively in thepsycholinguistic/neurolinguistic and brain imaging literature[58,59]. Notably, a number of studies has shown that engagingin high-level cognitive activities, such as reading text, appearsto preserve cognition in aging adults. The frequency ofparticipation in activities that are mentally stimulating, such asreading, is associated with lower risk of incident AD [59-61].Researchers have also linked reading and engaging inhigher-level cognitive activities with increased cognitive reserve,that in turn is associated with more tolerance of AD pathologyand stimulation of brain plasticity [62-65].Does Reduced Reading Effort Lead to ImprovedCognition?We previously found a positive correlation between readingspeed and higher scores on the Montreal Cognitive Assessment(MoCA) in persons with AMD [66,67]. Given the informationreviewed in the previous sections, the logical direction for ourinvestigation into the functional connection between low visionand cognition is to examine the possible effects of readingrehabilitation on the cognitive abilities of individuals undergoinglow vision rehabilitation. In order to disentangle the effects ofvisual and cognitive impairments in older adults, members ofthis research team have adapted cognitive tests so they can beadministered to individuals with low vision [68,69]. In parallel,we are also in the process of developing a vision-screening testthat can be administered to individuals with various levels ofcognitive impairment [70,71]. This investigation will guide ourfuture research efforts into the improvement of service provisionin low vision rehabilitation for the purpose of increasing theJMIR Res Protoc 2021 vol. 10 iss. 3 e19931 p. 3(page number not for citation purposes)

JMIR RESEARCH PROTOCOLSindependence and cognitive health of older adults living withlow vision.Objectives and HypothesesThe overall goal of the study is to demonstrate that low visionrehabilitation will improve reading, which, in turn, will improvecognition.The primary objective is to measure global changes in readingability and cognitive functioning before and after 6 months and12 months of reading rehabilitation. Hypothesis 1 is thatimprovements relative to pretreatment performance will beobserved at 6 months and maintained at 12 months forparticipants with vision loss only and less so for those with dualsensory impairment (DSI). Control participants are expected tohave stable performance and outperform both groups whoreceive reading rehabilitation. The global reading outcomes arereading speed, reading comprehension, and subjective perceptionof reading effort.The global measure of cognition is the MoCA.The secondary objective is to explore changes in more specificsubdomains of reading ability and cognitive functioning.Hypothesis 2 is that improvements relative to pretreatmentperformance will be observed at 6 months and maintained at12 months for participants with vision loss only and less so forthose with DSI. Control participants are expected to have stableperformance and outperform both groups who receive readingrehabilitation. The specific reading outcomes are reading acuity,critical print size, reading accuracy, and subjective reports ofchanges in reading habits.The specific measures of cognition are episodic learning;memory encoding, storage, and retrieval; attention, speed, andmental flexibility; and semantic fluency.Hypothesis 3 is that improved reading behavior will becorrelated with improved cognitive functioning across all L FORenderXWittich et algroups, with the strongest relationship being in the AMD-onlygroup. Such correlations will be observed across the global aswell as the specific measures.The tertiary objective is to explore factors that may influencethe cognitive benefits of reading rehabilitation. Hypothesis 4 isthat individual differences in the association between improvedreading behavior and cognitive functioning may be related toparticipant characteristics such as demographic variables,hearing impairment severity, and mental health.Study DesignWe present this protocol following the Standard Protocol Items:Recommendations for Interventional Trials (SPIRIT) guidelines[72]. An overview of the trial registration data is provided inTable 1. We decided on a 3-arm, quasiexperimental,repeated-measures design (nonrandomized, pre-post interventionstudy) [73], whereby participants act as their own comparisonacross time points. Given the prevalence of hearing loss amongolder adults, we decided to include both patients with AMDwho present with normal hearing [74,75] and those whoexperience both vision and hearing loss (DSI). We decided toadd an age-matched control group with healthy vision andhearing in order to observe the size of possible practice effectsand record general variability in the measures, given theexpected advanced age of our participants. The rehabilitationcenter partners on this study generally provide readingrehabilitation within 3 months of the initial optometricassessment. Therefore, we chose 6 and 12 months as suitablefollow-up time points. After 6 months, the initial interventionswill be completed, and participants will have had 3 months toengage in reading postintervention. Overall, a design with 3groups (AMD-only, DSI, comparison) x 3 test times(preintervention, 6 months, 12 months) is planned to allow usto examine whether cognitive performance will change overtime and if the degree of change and the final performance onoutcome measures will differ across groups.JMIR Res Protoc 2021 vol. 10 iss. 3 e19931 p. 4(page number not for citation purposes)

JMIR RESEARCH PROTOCOLSWittich et alTable 1. Trial registration data.Data categoryInformationPrimary registry and trial identifying numberClinicalTrials.gov ID: NCT04276610Date of registration in primary registryFebruary 19, 2020Secondary identifying numbersCRIR-1284-1217Source(s) of monetary or material support Primary sponsorFonds de recherche Quebec - Santé & Turmel Foundation (years 1 & 2);Canadian Institutes of Health Research Project Grant: Patient-OrientedResearch Priority Announcement (year 3)Contact for public queriesWalter.wittich@umontreal.caContact for scientific queriesWalter.wittich@umontreal.ca; natalie.phillips@concordia.caPublic & scientific titleWords on the Brain: Can Reading Rehabilitation for Age-Related VisionImpairment Improve Cognitive Functioning?Countries of recruitmentCanadaHealth condition(s) or problem(s) studiedAge-related macular degenerationDementiaIntervention(s)Behavioral: Low Vision Reading RehabilitationStudy typeInterventional clinical trial, nonrandomized, parallel assignmentDate of first enrollmentApril 24, 2019Target sample size225Recruitment statusRecruitingMethodsStudy SettingThe study will be conducted at 2 partnering vision rehabilitationcenters in the Montreal area, the Centre de réadaptationLethbridge-Layton-Mackay du Centre intégré universitaire desanté et de services sociaux du Centre-Ouestde-l’Île-de-Montréal and the Institut Nazareth et Louis-Brailledu Centre intégré de santé et de services sociaux de laMontérégie-Centre. Both sites are part of the Center forInterdisciplinary Rehabilitation Research of Greater Montrealand provide government-funded rehabilitation services, free ofcharge for eligible residents of Quebec, Canada.Eligibility CriteriaInclusion CriteriaParticipants in the intervention groups (AMD-only and DSI)are required to have a primary diagnosis of AMD (any type, asdrusen-containing beta amyloid are found in all types of AMD[26-28]) as confirmed by the ophthalmologist or optometristwho referred the individual to the vision rehabilitation centers.They must be able to benefit from a magnification interventionfor the purpose of improving their ability to read, according tothe clinical judgment of their rehabilitation professionals whococonstruct their personalized intervention plans. All participantsneed to be able to communicate in either English or French(their choice of dominant language) and have a distance visualacuity in the better eye of 20/60 or less with best standardrefraction, according to the admission criteria for eligibility forrehabilitation services in Quebec [76]. Individuals in the healthycontrol group are required to have age-normal hearing and vision(visual acuity better than 20/40 in the better eye, no e19931XSL FORenderXof visual impairment in the last 12 months) [77]. In line withthe hearing impairment categorizations used in Quebec [78],participants with unaided pure-tone averages (PTAs) across .5,1, 2, and 4 kHz in the better ear of 40 decibel hearing level (dBHL) or less will be considered to have no or mild hearingimpairment. Those with PTAs between 41 and 79 dB HL willbe considered participants with moderate to severe hearingimpairment and will be allocated to the DSI group. We will alsorecruit 75 age-matched older adults without visual impairment.Exclusion CriteriaParticipants cannot currently be undergoing any medicaltreatment for their AMD (eg, antivascular endothelial growthfactor therapy injections). They must have sufficient residualvision to benefit from magnification for the purpose of readingprinted paragraphs (visual acuity in the better eye of 20/400 orbetter). Based on past experience with participant recruitmentover the phone, recruitment success over the phone is low withindividuals living with more severe degrees of hearingimpairment. Therefore, those whose file information indicatesan audiogram with an unaided PTA 80 dB HL in their betterear will not be approached for recruitment [79]. In order tofacilitate the administration of informed written consent throughthe research assistants and to focus recruitment on older adultswith the necessary cognitive capacities to complete a somewhatlengthy protocol, individuals whose file information indicatesa diagnosis of an advanced cognitive impairment such as ADwill not be approached for recruitment. Participants whose totalscore on the MoCA is below 18 or whose score on the blindMoCA is below 10 will not be included in the study, becauseour clinical and research experience [80] has indicated thatindividuals with scores at that level are likely too cognitivelyimpaired to complete a research protocol with this level ofcomplexity. At the initial assessment, both the PTA and MoCAJMIR Res Protoc 2021 vol. 10 iss. 3 e19931 p. 5(page number not for citation purposes)

JMIR RESEARCH PROTOCOLSscores will be used to determine if participants continue furtherin the study.InterventionRehabilitation services at the partner centers will deliver thelow vision evaluation and reading rehabilitation intervention,as regulated by the Quebec Ministry of Health. Typically, within3 months of their initial low vision rehabilitation assessment,individuals will receive most of the recommended interventions.The clinical staff and rehabilitation professionals at eitherrehabilitation center decide which components of the fullcomplement of services are suited for each participant. The 2centers offer comparable services, including the provision ofassistive devices and services, as regulated by the Quebec HealthInsurance Program. These services are similar to those providedwithin the Blind Rehab Centers of the Veterans Affairs servicein the United States [46,47]. They include, but are not limitedto, a full optometric exam to determine functional vision,including refraction and the prescription of appropriate nearand distance glasses and optical devices; an assessment by alow vision therapist or occupational therapist to establish theparticipant’s functional priorities and rehabilitation goals; andthe provision of handheld optical magnification devices,electronic nonoptical magnification devices (eg, portable ortabletop closed-circuit TVs), or computer software for screencontent magnification (eg, ZoomText). All devices are providedfree of cost for the individual and with appropriate training andfollow-up sessions at home within 3 months of the initialintervention, as required. The rehabilitation professionals mayperform a systematic lighting assessment in the participants’homes [81-83] and may make specific lighting recommendationsthat are intended to improve their reading ability. In addition,participants will have access to referral services such asorientation and mobility training (for independent travel) orregistration with an adapted adult day center for individualswith sensory loss [80]. These centers provide access topsychosocial services, counsellors, social workers, or othermental health professionals. The provision of assistive devicesfor magnification and reading is generally linked to a follow-upvisit in the individual’s home 3 weeks after the initialrehabilitation appointment. At this time, rehabilitationprofessionals observe the use of the devices and strategies inthe environment where the participant lives. It is at this pointthat the professionals together with the participants decidewhether the devices are useful and are assigned as a permanentloan. Should additional needs emerge, the participant is at libertyto contact the rehabilitation center at any time to initiate a newservice episode. The rehabilitation professionals record allaspects of this intervention in the rehabilitation files, to whichthe research team will have access during and at the end of the12-month study period.OutcomesTest AdministrationThe order of test administration begins with the primary (MoCA,Minnesota Low Vision Reading Test, International ReadingSpeed Test, reading habits questionnaire) followed by thesecondary and then the participant characteristics measures;should a participant be unable to complete any one of XSL FORenderXWittich et almeasures due to its complexity or to fatigue, the experimentermoves on to the next test, using personal judgment as to theparticipant’s level of fatigue. Participants are encouraged totake as many breaks as they desire in order to facilitatecompletion of the maximum number of tests possible.Incomplete tests will not be scored; however, the number ofcompleted tests at each testing session will be compared. Notethat cognitive test administration can be adjusted to makeinstructions audible for persons with hearing loss. Ambientlighting at home in the room where participants generally readand where the tests are administered will be measured using aDigital Illuminance Meter (model LX1330B, Dr. Meter, UnionCity, CA).Cognition Outcome MeasuresAll cognitive measures are administered in the auditory domainand thus will not be affected by a visual impairment. Therefore,should performance on the cognitive measures improvefollowing the vision rehabilitation program, the improvementshould be attributable to the benefit of increased visual functionon cognitive stimulation as opposed to merely being due toimproved perception of the stimuli involved in the tests. It isreasonable to expect improvement on the chosen cognitivemeasures as a result of the reading intervention and within thetimeframe of the study. Notably, the chosen measures assesscognitive domains that have b

While hearing loss rehabilitation may have a beneficial effect on cognitive functioning, there are no data available on whether low vision rehabilitation, specifically for reading, could have a beneficial effect on cognitive health. Objective: The research questions are: (1) Does low vision rehabilitation reduce reading effort? (2) If so, does .