[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656806":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":45,"studyPopulation":39,"armGroups":46,"interventions":57,"overallOfficials":68,"centralContacts":72,"locations":39,"responsibleParty":78,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":39,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":39,"enrollmentInfo":93,"targetDuration":39,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":108,"whyStopped":39,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":39},{"fullName":5,"class":6},"Indiana University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Canadian Occupational Performance Measure (COPM)","The COPM will be used to measure self-perceived performance and satisfaction with meaningful IADLs. People living with dementia, or caregivers when needed, identify important activities and rate performance and satisfaction on a 1-10 scale. A change of 2 or more points in performance is considered clinically meaningful.","Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change in Cognitive Performance Test (CPT)","CPT is a performance-based measure of cognitive-functional capacity. In this study, the investigators will use it to examine participants' performance on IADL tasks embedded within the VR environment. This approach reflects their ability to complete complex tasks that demand higher-level cognitive processes such as planning, problem-solving, and working memory.",{"measure":18,"description":19,"timeFrame":12},"Change in Kettle Test","The Kettle Test is a brief and ecologically valid assessment of everyday problem-solving and executive function by observing participants' ability to prepare a hot beverage. It involves multiple steps, requiring sequencing, planning, and attention skills that are targeted in the VR training module.",{"measure":21,"description":22,"timeFrame":12},"Change in Kohlman Evaluation of Living Skills (KELS)","The KELS measures an individual's ability to perform essential living skills needed to live safely and independently. Specifically, the investigators will conduct the money management subtasks: including using cash to purchase items and paying utility bills.",{"measure":24,"description":25,"timeFrame":12},"Change in Mini-Mental State Examination (MMSE)","The MMSE is a widely used brief screening tool for detecting and measuring cognitive impairments. It is comprised of 11 questions that test orientation, registration, attention and calculation, recall, and language.",{"measure":27,"description":28,"timeFrame":12},"Change in Quality of Life in Alzheimer's Disease (QoL-AD)","QoL-AD is a validated measure designed to assess quality of life specifically in individuals with Alzheimer's disease. It incorporates both self-report and caregiver perspectives across domains such as physical health, mood, relationships, functional ability, and overall well-being. In this study, QoL-AD will provide insights into how participation in the VR training program influences participants' perceived quality of life, complementing the performance-based and cognitive assessments.",[30],{"measure":31,"description":32,"timeFrame":33},"Post-VR Intervention Interview","Participants within the VR-Based IADL Training arm and their caregivers will participate in a semi-structured interview. This will explore usability, emotional responses, task realism, and any perceived changes in everyday function. These findings will provide valuable context for interpreting results and will help guide iterative design improvements.","Week 4 immediately post-intervention",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":39,"timePerspective":39,"maskingInfo":40},"RANDOMIZED","PARALLEL","This is a two-arm, parallel-assignment randomized pilot trial. Eligible participants will be randomized in a 1:1 ratio to either the VR-based IADL training intervention group or the cognitive stimulation control group. Randomization will occur after eligibility is confirmed. An independent statistician who is not involved in recruitment, intervention delivery, or outcome assessment will generate the allocation sequence using variable block sizes. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. An unblinded research assistant who is not involved in outcome assessment will open the next envelope in sequence and implement the assigned condition.","SUPPORTIVE_CARE",null,{"masking":41,"maskingDescription":42,"whoMasked":43},"SINGLE","The outcome assessor will remain blinded to group assignment throughout data collection and data entry. Participants will be instructed not to disclose their assigned group to the outcome assessor. The blinded assessor will not be involved in intervention delivery, adherence check-ins, activity adjustments, or other procedures that could reveal group assignment. An unblinded research assistant who is not involved in outcome assessment will implement the assigned intervention and conduct weekly adherence check-ins. Data analysts will receive de-identified datasets labeled only with group codes to help preserve masking during statistical comparisons.",[44],"OUTCOMES_ASSESSOR","This study is a single-blind, two-arm randomized pilot trial designed to evaluate the preliminary therapeutic impact of a customizable, home-based virtual reality (VR) training system for people living with dementia. The intervention is intended to support engagement and performance in instrumental activities of daily living (IADLs), such as preparing food, washing dishes, managing money, or completing household tasks.\n\nParticipants will be randomized in a 1:1 ratio to either the intervention group or the control group. Participants assigned to the intervention group will complete IADL-based VR training. The VR system includes simulated home environments, such as a kitchen, where participants can practice IADLs such as retrieving ingredients for cooking and washing dishes. The system is designed to provide safe, structured, and repeatable practice of functional tasks that may otherwise be difficult to practice in real-world settings because of safety or logistical concerns.\n\nParticipants assigned to the control group will complete cognitive stimulation activities, such as word puzzles. This comparison condition reflects a traditional non-pharmacological approach that is commonly used to support cognitive engagement among people living with dementia.\n\nThe intervention period will last four weeks. Participants will complete 30-minute home-based sessions five times per week. Outcomes will be assessed at baseline, immediately after the four-week intervention period, and at a follow-up visit four weeks after the intervention ends. These assessments will examine changes in IADL performance, cognitive-functional ability, cognitive status, and quality of life.\n\nIn addition to standardized assessments, participants in the VR group and their caregivers will complete a brief exit interview after the intervention period. These interviews will gather feedback on usability, task realism, emotional responses, perceived benefits, and barriers or facilitators to using the VR system at home. Qualitative findings will be used to guide future refinements to the VR program and improve its accessibility, usability, and relevance for people living with dementia and their caregivers.\n\nAs a pilot trial, this study is intended to provide preliminary evidence about feasibility, engagement, and potential efficacy. Findings will inform the design of a future fully powered randomized controlled trial evaluating VR-based training for IADLs among people living with dementia.",[47,52],{"label":48,"type":49,"description":39,"interventionNames":50},"VR-Based IADL Training","EXPERIMENTAL",[51],"Device: At-Home VR-Based IADL Training",{"label":53,"type":54,"description":39,"interventionNames":55},"Cognitive Stimulation Control","ACTIVE_COMPARATOR",[56],"Behavioral: Cognitive Stimulation Activities",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":39},"DEVICE","At-Home VR-Based IADL Training","The intervention is designed to provide safe, structured, and repeatable practice of everyday activities in a virtual environment.",[48],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"BEHAVIORAL","Cognitive Stimulation Activities","This intervention includes structured word-based cognitive activities (e.g., crossword puzzles, logic games).",[53],[69],{"name":70,"affiliation":5,"role":71},"Hee-Tae Jung, PhD","PRINCIPAL_INVESTIGATOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":39,"email":77},"Erica Babb, MS","CONTACT","7655248768","ecbabb@iu.edu",{"type":71,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Hee-Tae Jung","Assistant Professor of Health Informatics",[82],{"name":83,"class":6},"Alzheimer's Association","100656806","virtual-reality-training-to-support-daily-activities-for-people-living-with-dementia-100656806",false,"NCT07829913","Virtual Reality Training to Support Daily Activities for People Living With Dementia","Investigating the Impact of VR-Assisted Training on Daily Activity Performance Among People Living With Dementia","Inclusion Criteria:\n\n* Clinical diagnosis of Alzheimer's disease or a dementia-related condition that shares similar or overlapping symptoms with Alzheimer's disease, confirmed by a licensed healthcare provider (e.g., neurologist, geriatrician, or primary care physician); for caregiver-reported diagnoses, supporting documentation must be obtained prior to enrollment.\n* MMSE score between 20 to 25 (mild dementia)\n* Capacity to consent\n* Ability to engage meaningfully in at least one IADL task relevant to the intervention, ensuring capacity to interact with the functional tasks targeted within the VR system.\n* Safe, quiet home environment appropriate for VR, with access to an indoor space suitable for engaging in study activities:\n\nAt least 3 × 3 feet of unobstructed floor space. Adequate lighting to clearly view the device and physical surroundings. Stable chair without wheels for VR use.\n\n* Willingness and ability to follow the study protocol, including completion of 30-minute intervention sessions five times per week for four weeks and participation in assessment sessions at baseline (Week 0), post-intervention (Week 4), and follow-up (Week 8).\n* English language proficiency sufficient to complete the intervention and assessments, including interviews, cognitive testing, and interactive VR tasks.\n* Participants must have access to a smartphone, owned by the participant or their caregiver, and be willing to use it to host the VR application.\n\nCaregivers' inclusion criteria include:\n\n* Age 18 years or older\n* Primary familial or spousal caregiver who provides daily care\n\nExclusion Criteria:\n\n* Impaired reasoning\u002Fjudgment that affects daily life\n* Severe visual, hearing, or motor impairments that would limit the participant's ability to use VR safely or engage with the system's content.\n* Significant psychiatric or neurological conditions (e.g., active psychosis, uncontrolled depression, recent seizures) that may interfere with participation or safety.\n* Medical conditions that pose safety risks, including those that could be aggravated by visual immersion (e.g., uncontrolled vertigo, history of VR-induced motion sickness).\n* Significant acute or chronic medical, neurological, or other illnesses that, in the judgment of the principal investigator (PI), could compromise participant safety, hinder study completion, or interfere with study objectives.\n* Concurrent participation in other interventional studies, particularly those involving cognitive rehabilitation or VR, that may confound study results.\n* MMSE score below 20, indicating cognitive impairments more advanced than mild dementia.","ALL","18 Years",{"count":94,"type":95},40,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study will test whether a home-based virtual reality training program can help people living with dementia practice everyday activities. Many people with dementia experience difficulty completing instrumental activities of daily living, such as preparing food, washing dishes, managing money, or completing household tasks. Virtual reality may provide a safe and engaging way to practice these activities in a realistic environment.\n\nParticipants will be randomly assigned to one of two groups. One group will use a virtual reality training program focused on everyday activities, and the other group will complete cognitive stimulation activities, such as word puzzles. The study will last four weeks, with 30-minute sessions completed at home five times per week. Participants will complete assessments at the beginning of the study, after the four-week program, and again four weeks later.\n\nThe study team hypothesizes that people who use the virtual reality training program may show greater improvements in everyday activity performance, engagement, and quality of life compared with people who complete traditional cognitive stimulation activities.",[101],"Dementia",[103,104,105,106,107],"Virtual Reality","Occupational Therapy","Instrumental Activities of Daily Living","Rehabilitation","Home-Based Intervention","NOT_YET_RECRUITING","2026-09-17",{"date":111,"type":112},"2026-09-21","ACTUAL",{"date":114,"type":95},"2026-10",{"date":116,"type":95},"2026-12",{"name":5,"class":6}]