[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657438":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":62,"interventions":75,"overallOfficials":84,"centralContacts":92,"locations":98,"responsibleParty":128,"collaborators":130,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":53,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":53,"enrollmentInfo":146,"targetDuration":53,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":168,"whyStopped":53,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Callahan-Young LLC DBA Jigsawdio","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":53},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale","Quality of life will be measured using the Quality of Life in Alzheimer's Disease scale (QoL-AD). Total scores range from 13 to 52, with higher scores indicating better quality of life.","Baseline, Week 6, and Week 12",{"measure":14,"description":15,"timeFrame":12},"Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15","Depressive symptoms will be measured using the 15-item Geriatric Depression Scale (GDS-15). Total scores range from 0 to 15, with higher scores indicating greater depressive symptoms.",{"measure":17,"description":18,"timeFrame":12},"Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7","Anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.",[20,23,26,29,33,37,41,45,49],{"measure":21,"description":22,"timeFrame":12},"Change in Global Cognition Measured by the Montreal Cognitive Assessment","Global cognition will be measured using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.",{"measure":24,"description":25,"timeFrame":12},"Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score","Perceived cognitive function will be measured using the six-item Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function v2.0 Short Form 6a. Raw scores are converted to standardized T-scores ranging from 23.13 to 63.17, with higher scores indicating better perceived cognitive function.",{"measure":27,"description":28,"timeFrame":12},"Change in Caregiver-Reported Quality of Life","Caregivers or informants will complete the proxy version of the Quality of Life in Alzheimer's Disease scale. Scores range from 13 to 52, with higher scores indicating better perceived quality of life.",{"measure":30,"description":31,"timeFrame":32},"Participant Engagement During Puzzle Sessions","Engagement will be evaluated during puzzle sessions using the Engagement of a Person with Dementia Scale (EPWDS). Each of the 10 items is rated from 1 to 5. Items 2, 4, 6, 8, and 10 are reverse scored. Total scores range from 10 to 50, with higher scores indicating greater positive engagement.","During each of the 12 puzzle sessions over Weeks 1-6",{"measure":34,"description":35,"timeFrame":36},"Session Completion and Program Adherence","Adherence will be measured as the number and percentage of the 12 scheduled puzzle sessions completed by each participant.","Through Week 6",{"measure":38,"description":39,"timeFrame":40},"Time on Task","The amount of time each participant spends engaged in each puzzle session will be recorded in minutes.","During each of the 12 puzzle sessions over Weeks 1-6.",{"measure":42,"description":43,"timeFrame":44},"Participant and Caregiver Satisfaction and Acceptability","Participant and caregiver satisfaction, perceived benefits, and challenges associated with the program will be assessed through feedback interviews.","Week 6",{"measure":46,"description":47,"timeFrame":48},"Recruitment Rate","Recruitment feasibility will be measured as the number and percentage of screened individuals who enroll in the study.","At completion of enrollment, up to 7 months",{"measure":50,"description":51,"timeFrame":52},"Retention Rate","Retention will be measured as the number and percentage of enrolled participants who complete the Week 12 follow-up assessment.","Through Week 12",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":59,"maskingDescription":53,"whoMasked":60},"SINGLE",[61],"OUTCOMES_ASSESSOR",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Jigsawdio Multisensory Puzzle Program","EXPERIMENTAL","Participants will complete two 30 to 40 minute Jigsawdio sessions per week for six weeks, for a total of 12 sessions. Jigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad.",[68],"Behavioral: Jigsawdio Multisensory Puzzle Platform",{"label":70,"type":71,"description":72,"interventionNames":73},"Standard Jigsaw Puzzle Program","ACTIVE_COMPARATOR","Participants will complete two approximately 30- to 40-minute standard jigsaw puzzle sessions per week for six weeks, for a total of 12 sessions. Commercially available dementia-friendly puzzles will be used as the comparison activity.",[74],"Behavioral: Standard Jigsaw Puzzle Activity",[76,81],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":53},"BEHAVIORAL","Jigsawdio Multisensory Puzzle Platform","Jigsawdio is a personalized multisensory puzzle platform that combines transparent physical puzzle pieces with images, stories, and audio presented through an iPad. Participants will complete two approximately 30- to 40-minute Jigsawdio sessions per week for six weeks, for a total of 12 sessions.",[64],{"type":77,"name":82,"description":72,"armGroupLabels":83,"otherNames":53},"Standard Jigsaw Puzzle Activity",[70],[85,89],{"name":86,"affiliation":87,"role":88},"Junhyoung Kim, PhD","Texas A&M University","PRINCIPAL_INVESTIGATOR",{"name":90,"affiliation":91,"role":88},"Maria Marquine, PhD","Duke University",[93],{"name":94,"role":95,"phone":96,"phoneExt":53,"email":97},"Amy M Young, BBA","CONTACT","9196965364","amy@jigsawdio.com",[99,115],{"facility":91,"status":53,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Durham","North Carolina","27710","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-78.89862,35.99403,{"lat":109,"lon":108},[112],{"name":90,"role":95,"phone":113,"phoneExt":53,"email":114},"(919) 681-2980","maria.marquine@duke.edu",{"facility":87,"status":53,"city":116,"state":117,"zip":118,"country":103,"countryCode":104,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"College Station","Texas","77843",{"type":106,"coordinates":120},[121,122],-96.33441,30.62798,{"lat":122,"lon":121},[125],{"name":86,"role":95,"phone":126,"phoneExt":53,"email":127},"979-436-9372","kim9@tamu.edu",{"type":129,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[131,134,136],{"name":132,"class":133},"National Institute on Aging (NIA)","NIH",{"name":87,"class":135},"OTHER",{"name":91,"class":135},"100657438","jigsawdio-multisensory-platform-for-people-with-mild-cognitive-impairment-alzheimers-disease-or-related-dementias-100657438",false,"NCT07839286","Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias","Evaluating the Health Benefits of Jigsawdio: A Novel Multisensory Jigsaw Puzzle-Based Platform for Alzheimer's Disease and Related Dementias","Inclusion Criteria:\n\n1. Age: 60 years or older.\n2. Able to communicate fluently in English.\n3. Mild cognitive impairment or mild dementia based on an existing diagnosis or study screening procedures.\n4. Has an informant and a puzzle creator who know the participant and are willing to participate in the study; the same person may serve in both roles.\n\nExclusion Criteria:\n\n1. Severe uncorrected visual or hearing impairment that would prevent puzzle use.\n2. Severe motor impairment that would prevent puzzle use.\n3. Concurrent participation in a similar program or Alzheimer's disease intervention study.\n4. Current hospice care or terminal illness.\n5. Plans to relocate within three months after the baseline assessment.\n6. History of a serious mental illness, such as bipolar disorder or schizophrenia, that would interfere with study participation.\n7. Unable to provide informed consent and no legally authorized representative is available","ALL","60 Years",{"count":147,"type":148},80,"ESTIMATED","INTERVENTIONAL",[151],"NA","This study will evaluate Jigsawdio, a personalized multisensory jigsaw puzzle platform, for adults aged 60 years and older with mild cognitive impairment or mild dementia. Approximately 80 participants will be randomly assigned to either the Jigsawdio group or a control group using standard dementia-friendly jigsaw puzzles. Both groups will complete two 30- to 40-minute puzzle sessions per week for six weeks, for a total of 12 sessions.\n\nJigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad. The study will compare changes in depression, anxiety, quality of life, cognition, engagement, satisfaction, and program feasibility. Assessments will be completed at baseline, after the six-week program, and at a 12-week follow-up. Information may also be collected from participants' caregivers or informants.",[154,155,156],"Alzheimer Disease","Dementia","Mild Cognitive Impairment",[158,159,160,161,162,163,164,165,166,167],"Jigsawdio","Multisensory Jigsaw Puzzle","Cognitive Engagement","Nonpharmacological Intervention","Older Adults","Quality of Life","Emotional Well-Being","Multisensory Engagement","Personalized Activities","dementia engagement","NOT_YET_RECRUITING","2026-09-23",{"date":171,"type":172},"2026-09-25","ACTUAL",{"date":174,"type":148},"2026-10",{"date":176,"type":148},"2027-05",{"name":5,"class":6},2]