[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659005":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":44,"studyPopulation":41,"armGroups":45,"interventions":52,"overallOfficials":57,"centralContacts":61,"locations":70,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":41,"enrollmentInfo":105,"targetDuration":41,"studyType":108,"phases":109,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":126,"whyStopped":41,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Université de Montréal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Knowledge About Alzheimer's Disease Assessed Using the Alzheimer's Disease Knowledge Scale (ADKS)","Knowledge about Alzheimer's disease will be assessed using the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is a 30-item questionnaire with true\u002Ffalse response options that assesses knowledge about Alzheimer's disease across several domains. Each correct response receives one point, producing a total score ranging from 0 to 30. Higher scores indicate greater knowledge about Alzheimer's disease. Change in ADKS total score from baseline to Month 6 will be evaluated.","Baseline to 6 months",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Change in Self-Efficacy Assessed Using the General Self-Efficacy Scale (GSE)","Self-efficacy will be assessed using the General Self-Efficacy Scale (GSE), a 10-item questionnaire measuring perceived ability to cope with difficult situations and achieve goals. Each item is rated on a 4-point scale. Item scores are summed to produce a total score ranging from 10 to 40, with higher scores indicating greater perceived self-efficacy. Change in GSE total score from baseline to Month 3 and Month 6 will be evaluated.","Baseline to Month 3 and Month 6",{"measure":19,"description":20,"timeFrame":21},"Usability of Brain Health Pro Assessed Using the Adapted System Usability Scale (SUS)","Usability will be assessed using the System Usability Scale (SUS), adapted for SENSE-Brain Health Pro. The adapted questionnaire includes items assessing frequency of website use and perceived usability, including ease of use, navigation, complexity, consistency, confidence, need for technical assistance, and ease of learning. Usability items are rated on a 5-point scale from strongly disagree to strongly agree. Additional study-specific items assess accessibility and are reported separately as an accessibility outcome.","3 months and 6 months",{"measure":23,"description":24,"timeFrame":21},"Acceptability of Brain Health Pro Assessed Using the Adapted Technology Acceptance Model (TAM) Questionnaire","Acceptability will be assessed using a 29-item Technology Acceptance Model (TAM) Questionnaire adapted for SENSE-Brain Health Pro. The questionnaire includes 26 structured items assessing perceived usefulness, communication, everyday benefits, website experience, and accessibility experience. Structured items are rated on a 7-point scale from strongly disagree to strongly agree. Three open-ended questions assess helpful accessibility features, suggested accessibility improvements, and barriers experienced while using Brain Health Pro.",[26,29,33],{"measure":27,"description":28,"timeFrame":21},"Perceived Dementia Risk and Risk-Reduction Behaviours Assessed Using PRISM-PC","Participants' perceptions of dementia risk and engagement in dementia risk-reduction behaviours will be assessed using Sections B and D of the Perceptions Regarding Investigational Screening for Memory in Primary Care (PRISM-PC) questionnaire.",{"measure":30,"description":31,"timeFrame":32},"Accessibility Accommodations and Experiences With Brain Health Pro","Accessibility accommodations will be assessed using the SENSE-BHPro Accessibility Accommodations Questionnaire. The questionnaire documents vision-related accommodations, hearing-related accommodations, computer accessibility settings, assistance received from others, and participants' perceived usefulness of the accommodations used. Additional comments about accessibility accommodations may also be provided.","Baseline, 3 months and 6 months",{"measure":34,"description":35,"timeFrame":21},"Barriers and Facilitators to Using Brain Health Pro","Barriers and facilitators will be assessed using the SENSE-BHPro Accessibility Barriers and Facilitators Questionnaire. Structured items assess ease of access and navigation, readability, audio accessibility, visual presentation, compatibility with assistive technologies, specific barriers and facilitators, and overall satisfaction. Agreement items use a 5-point scale from strongly disagree to strongly agree. Open-ended questions ask participants to describe their main accessibility barrier, what helped them most, and recommended improvements.",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":41,"timePerspective":41,"maskingInfo":42},"NA","SINGLE_GROUP","All participants will receive the Brain Health Pro intervention. Outcomes will be assessed within participants over time using a one-group pretest-post-test design.","PREVENTION",null,{"masking":43,"maskingDescription":41,"whoMasked":41},"NONE","SENSE-Brain Health Pro (SENSE-BHPro) is a prospective, multi-site study using a one-group pretest-post-test design with an embedded mixed-methods process evaluation. The study evaluates the accessibility, acceptability, usability, and outcomes associated with participation in the web-based Brain Health Pro (BHPro) program among older adults with self-reported hearing and\u002For vision difficulties.\n\nHearing and vision difficulties are common in older adulthood and are associated with increased risk of cognitive decline and dementia. Digital dementia prevention programs have the potential to reach large numbers of older adults; however, sensory difficulties may create barriers to accessing and engaging with digitally delivered interventions. The original BHPro program was not specifically implemented in a population selected for hearing and\u002For vision difficulties, and its accessibility and usability in this population have not been systematically evaluated. SENSE-BHPro addresses this gap by examining both intervention outcomes and the accessibility and implementation of BHPro for older adults with sensory difficulties.\n\nApproximately 300 community-dwelling adults aged 55 years and older with self-reported hearing difficulties, vision difficulties, or combined hearing and vision difficulties will be recruited across Canada. Participants will have no self-reported diagnosis of dementia. Individuals who are cognitively unimpaired, report subjective cognitive concerns, or have mild cognitive impairment may participate if they otherwise meet the study eligibility criteria.\n\nParticipants will complete the BHPro program, a web-based multidomain psychoeducational dementia risk-reduction program. BHPro provides individualized feedback on potentially modifiable dementia risk factors and evidence-based educational content addressing lifestyle, vascular, psychosocial, and cognitive health domains. Participants receive a personalized risk profile, practical recommendations, and structured guidance intended to support goal setting and self-management. The core intervention is delivered progressively through structured online modules over six months.\n\nAssessments will occur at screening, baseline, Month 3, and Month 6. The primary outcome is change in knowledge about Alzheimer's disease from baseline to Month 6, assessed using the Alzheimer's Disease Knowledge Scale (ADKS). Secondary and exploratory evaluations include self-efficacy, uptake of risk-reducing behaviours, psychological well-being, lifestyle factors, usability, acceptability, accessibility, and engagement with the intervention.\n\nAccessibility is a central component of the study. Participants will receive information and guidance regarding accessibility features available within BHPro and on their own devices, such as captions, text magnification, contrast settings, and audio adjustments, as appropriate. Use of accessibility features and assistive technologies will be documented to better understand how participants with different sensory profiles engage with the digital intervention.\n\nOutcomes and implementation experiences will also be examined across three sensory subgroups: participants with hearing difficulties, vision difficulties, and combined hearing and vision difficulties. The study will also examine individual characteristics that may influence engagement and outcomes, including sensory profile and severity, demographic characteristics, cognitive status, and the perceived functional effects of sensory difficulties.\n\nAn embedded process evaluation will examine recruitment pathways, participant engagement, adherence patterns, accessibility needs, barriers and facilitators to participation, and implementation considerations relevant to integrating BHPro within primary care and community-based settings serving older adults with hearing and\u002For vision difficulties. Findings are intended to inform future adaptations and implementation of accessible digital dementia risk-reduction programs.",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Brain Health Pro","EXPERIMENTAL","Participants will use the Brain Health Pro (BHPro) web-based program for six months. BHPro provides personalized information and recommendations about potentially modifiable dementia risk factors and supports participants in making health and lifestyle changes that may promote brain health.",[51],"Behavioral: Brain Health Pro",[53],{"type":54,"name":47,"description":55,"armGroupLabels":56,"otherNames":41},"BEHAVIORAL","Brain Health Pro (BHPro) is a web-based educational program designed to support dementia risk reduction. Participants receive personalized information about potentially modifiable dementia risk factors and evidence-based recommendations related to lifestyle, vascular, psychosocial, and cognitive health. The program supports goal setting and behaviour change through structured online modules delivered progressively over six months.",[47],[58],{"name":59,"affiliation":5,"role":60},"Walter Wittich, PhD FAAO CLVT","PRINCIPAL_INVESTIGATOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":41,"email":66},"Elena Guseva, PhD","CONTACT","514 343 7962","elena.guseva@umontreal.ca",{"name":68,"role":64,"phone":65,"phoneExt":41,"email":69},"Walter Wittich, PhD","walter.wittich@umontreal.ca",[71],{"facility":72,"status":41,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"School of Optometry","Montreal","Quebec","H3T 1P1","Canada","CA",{"type":79,"coordinates":80},"Point",[81,82],-73.58781,45.50884,{"lat":82,"lon":81},[85,87,88],{"name":63,"role":64,"phone":86,"phoneExt":41,"email":66},"+1514 343 7962",{"name":59,"role":64,"phone":86,"phoneExt":41,"email":69},{"name":59,"role":60,"phone":41,"phoneExt":41,"email":41},{"type":90,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[92],{"name":93,"class":94},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100659005","sense-brain-health-pro-for-older-adults-with-sensory-loss-100659005",false,"NCT07856888","SENSE-Brain Health Pro for Older Adults With Sensory Loss","SENSE-Brain Health Pro: Evaluation of a Digital Intervention Targeting Modifiable Dementia Risk Factors in Older Adults With Sensory Loss","SENSE-BHPro","Inclusion Criteria:\n\n1. Be 55 years of age or older.\n2. Reside in Canada.\n3. Self-report vision difficulties, hearing difficulties, or both (dual sensory difficulties), as determined using the study's sensory screening questionnaire adapted from the Canadian Longitudinal Study on Aging (CLSA) and the COMPASS-ND clinical assessment battery.\n4. Have no self-reported diagnosis of dementia or Alzheimer's disease. Individuals with self-reported mild cognitive impairment (MCI) will be eligible.\n5. Be willing to complete the study's self-reported cognitive screening questionnaire, including questions regarding previous cognitive diagnosis, subjective cognitive decline, and family history of dementia.\n6. Have access to a computer, tablet, or smartphone with internet access and be willing to participate in the web-based BHPro program using accessibility features and\u002For assistive technologies, as needed.\n7. Be able to communicate in English or French using their preferred accessible communication format.\n8. Be able and willing to provide informed consent.\n9. Be willing to participate in the six-month BHPro intervention and complete the scheduled study assessments.\n10. Have a primary care provider (e.g., family physician or nurse practitioner) or another healthcare professional involved in their care and agree that clinically significant incidental findings, if any, may be communicated to that provider.\n\nExclusion Criteria:\n\n1. Self-reported diagnosis of dementia or Alzheimer's disease.\n2. Inability, in the opinion of the investigator, to provide informed consent or to participate safely and meaningfully in study procedures.\n3. Insufficient proficiency in English or French to complete the BHPro program and study questionnaires, even with available accessibility supports.\n4. Vision and\u002For hearing difficulties that would preclude participation in the online BHPro program or completion of study assessments, even with usual corrective aids, assistive technologies, accessibility features, or support from the study team.\n5. Lack of access to an internet-enabled device and internet connection sufficient to participate in the online BHPro program and complete study procedures.\n6. Inability or unwillingness to receive study communications by email, telephone, videoconference, or another mutually acceptable remote communication format.\n7. Participation in another intervention study that, in the opinion of the investigator, would interfere with participation in BHPro or interpretation of study outcomes.","ALL","55 Years",{"count":106,"type":107},300,"ESTIMATED","INTERVENTIONAL",[37],"The goal of this study is to learn about the outcomes, usability, and accessibility of the online Brain Health Pro program for older adults with hearing difficulties, vision difficulties, or both. Brain Health Pro (BHPro) provides information and practical suggestions about ways people may support their brain health and lower their risk of dementia.\n\nThe main questions this study aims to answer are:\n\nDoes participants' knowledge about dementia and its risk factors change after using Brain Health Pro? How usable and accessible is Brain Health Pro for people with hearing or vision difficulties? What factors help or make it more difficult for participants to use and complete the program?\n\nAbout 300 adults aged 55 years and older with hearing difficulties, vision difficulties, or both will take part in the study. Participants will:\n\nUse the online Brain Health Pro program for six months. Complete online questionnaires before starting the program and again at 3 and 6 months.\n\nShare their experiences using the program, including any difficulties related to hearing, vision, or using the online program.\n\nResearchers will also look at whether participants make changes in health behaviours that may support brain health and whether they feel more confident about making these changes.",[112,113,114,115],"Vision and Hearing Loss","Vision Impairment","Hearing Impairment","Vision Difficulty",[117,118,119,120,121,122,123,124,125,101],"Dementia Risk Reduction","Brain Health","Sensory Loss","Dual Sensory Loss","Digital Health","Dementia Literacy","Health Education","Accessibility","Brain Health PRO","NOT_YET_RECRUITING","2026-09-28",{"date":129,"type":130},"2026-10-05","ACTUAL",{"date":132,"type":107},"2026-10-15",{"date":134,"type":107},"2028-04-15",{"name":5,"class":6},1]