[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660013":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":34,"armGroups":39,"interventions":50,"overallOfficials":34,"centralContacts":56,"locations":66,"responsibleParty":82,"collaborators":84,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":34,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":34,"enrollmentInfo":99,"targetDuration":34,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":118,"whyStopped":34,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"HiDO Technologies","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Medication Adherence","Medication adherence will be assessed using the Medication Adherence Rating Scale (MARS) and Proportion of Days Covered (PDC). The HomeCare system will track adherence through its automated logging of medication usage and AI-powered monitoring algorithms.","12 months",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Incidence of Hospitalizations","The frequency of hospitalizations and emergency room visits will be recorded and compared between the intervention and control groups.",{"measure":18,"description":19,"timeFrame":20},"ECOG Cognitive Assessment","The ECOG assessment will measure changes in cognitive function over the study period.","Baseline, 6 months, 12 months",{"measure":22,"description":23,"timeFrame":20},"Zarit Burden Interview (ZBI) Score","Caregiver burden will be evaluated using the Zarit Burden Interview, a validated tool for assessing the psychological impact on caregivers.",[25,28],{"measure":26,"description":27,"timeFrame":12},"Behavioral Changes in Medication Management","Assess the effectiveness of HomeCare's interventions (e.g., SMS notifications, video messages) on altering patient behavior regarding medication adherence.",{"measure":29,"description":30,"timeFrame":20},"EQ-5D-5L Health Questionnaire","The EQ-5D-5L will assess health-related quality of life for patients and caregivers.",{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":34,"timePerspective":34,"maskingInfo":36},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":37,"maskingDescription":34,"whoMasked":34},"NONE","This is a two-arm randomized controlled trial evaluating the HomeCare Pharmacy Distribution System for medication management among adults living with dementia, Alzheimer's disease, or Alzheimer's disease-related dementias.\n\nThe study will enroll 120 participants with dementia and their caregivers. Participants will be randomized to either the HomeCare intervention group or a standard-care control group. Participants assigned to the intervention group will use the HomeCare system for medication management. The system is designed to automate medication dispensing, monitor medication adherence, document medication-use patterns, and provide real-time alerts to caregivers. Participants assigned to the control group will continue using traditional medication-management methods, including pill bottles or blister packs.\n\nThe primary objective is to evaluate medication adherence over 12 months. Medication adherence will be assessed using the Medication Adherence Rating Scale and Proportion of Days Covered, together with medication-use information collected through the HomeCare system for participants in the intervention group.\n\nAdditional outcomes will include hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and behavioral changes related to medication management. Cognitive function will be assessed using the Everyday Cognition assessment at baseline, 6 months, and 12 months. Caregiver burden and quality-of-life measures will also be collected during the study.\n\nCaregivers in both study groups will receive study-related training and will complete surveys and other assessments related to caregiver burden, quality of life, medication-management activities, and their experience supporting the participant.\n\nParticipants will be age 65 or older and will have dementia, Alzheimer's disease, or a related dementia. The study will be conducted in collaboration with the University of California, Davis. Participants will be followed for 12 months. Study procedures include regular participant and caregiver follow-up, monitoring for device-related issues and adverse events, and collection of study outcome data.\n\nSafety procedures include participant and caregiver training, regular study-team contact, secure handling of study data, and access to backup medication supplies if technical problems with the HomeCare device occur. Participants may withdraw from the study at any time.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"HomeCare System (Intervention Group)","EXPERIMENTAL","Participants in this arm will use the HomeCare system for medication management. The HomeCare system automates medication reminders, records medication intake, and provides caregivers with real-time alerts about adherence and patient behaviors. The system integrates medication dispensing, adherence monitoring, Video Directly Observed Therapy (VDOT), intervention support, and prescription information over the 12-month study period.",[45],"Device: HomeCare",{"label":47,"type":48,"description":49,"interventionNames":34},"Standard of Care (Control Group)","NO_INTERVENTION","Participants in this arm will follow the current standard of care for medication management using manual methods such as pill bottles or blister packs. Caregivers or participants will manually track medication adherence and manage medication schedules without technological assistance.",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":34},"DEVICE","HomeCare","An automated, secure, AI driven medication delivery and observation platform to maximize therapy compliance, provide continuous medication monitoring and outcomes for individuals impacted by AD\u002FADRD.",[41],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":34,"email":61},"Charles Gellman, MSHI, MBA","CONTACT","510-813-7224","charles@hidohealth.com",{"name":63,"role":59,"phone":64,"phoneExt":34,"email":65},"Sarah Tomaszewski-Farias, PhD","916-734-6442","farias@ucdavis.edu",[67],{"facility":68,"status":34,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"University of California, Davis","Davis","California","95618-6153","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-121.74052,38.54491,{"lat":78,"lon":77},[81],{"name":63,"role":59,"phone":64,"phoneExt":34,"email":65},{"type":83,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[85,88],{"name":86,"class":87},"National Institute on Aging (NIA)","NIH",{"name":68,"class":89},"OTHER","100660013","homecare-medication-management-for-people-with-dementia-100660013",false,"NCT07872072","HomeCare Medication Management for People With Dementia","Behavioral Shifts in Dementia Patients Using Novel Pharmacy Home Robotics: A Cost-Effective Approach to Aging in Place","Inclusion Criteria:\n\n* Age 65 years or older.\n* Living with dementia, Alzheimer's Disease, or Alzheimer's Disease Related Dementias (AD\u002FADRD) according to standardized diagnostic criteria.\n* Capable of providing informed consent or have a legally authorized representative available to consent on their behalf.\n* Access to a smartphone, tablet, or computer with internet connectivity. Able to communicate in either English or Spanish.\n\nExclusion Criteria:\n\n* Significant comorbidities or medical conditions that could interfere with participation or severe cognitive function.\n* History of severe psychiatric illness or substance abuse disorder.\n* Recent participation in other clinical trials targeting cognition or dementia.\n* Unwillingness or inability to comply with study procedures.\n* Residence in a long-term care facility or institutional setting that may limit access to the home-based study intervention.","ALL","65 Years",{"count":100,"type":101},120,"ESTIMATED","INTERVENTIONAL",[104],"NA","This study will evaluate whether the HomeCare medication management system can improve medication adherence and related outcomes for adults age 65 and older living with dementia, Alzheimer's disease, or related dementias.\n\nHomeCare is an internet-connected medication management device that can automate medication dispensing, monitor medication use, and provide alerts to caregivers. The system is integrated with a Pharmacy Distribution System designed to track medications from pharmacy delivery through use in the home.\n\nA total of 120 participants with dementia will be randomly assigned to one of two groups. One group will use the HomeCare system, while the other group will continue using standard medication management methods, such as pill bottles or blister packs. Participants will be followed for 12 months. The main outcome is medication adherence. The study will also examine hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and changes in medication-management behavior. Caregivers will also participate in surveys and study assessments. The study is intended to determine whether HomeCare can improve medication management and support both people living with dementia and their caregivers.",[107,108],"Dementia","Alzheimer's Disease and Related Dementias",[10,53,110,111,112,113,114,115,116,117],"Medication Management","Pharmacy Distribution System","Caregiver Burden","Cognitive Function","Hospitalization","Quality of Life","Video Direct Observed Therapy","Older Adults","NOT_YET_RECRUITING","2026-10-07",{"date":121,"type":122},"2026-10-13","ACTUAL",{"date":124,"type":101},"2027-01-01",{"date":126,"type":101},"2027-05-31",{"name":5,"class":6},1]