Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-30 @ 6:11 AM
Study NCT ID:
NCT04308512
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2020-03-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Care Coordination System for People With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'najafi.bijan@gmail.com', 'phone': '(424) 467-7127', 'title': 'Dr. Bijan Najafi', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group: Care coordination with active Nili System', 'description': 'Dyad participants in the intervention group received the Active Nili system. Essential activities of daily living (ADL) were pre-programmed by a care coordination expert for the Active Nili Care Phase. In addition, patients and their caregivers were able to schedule supplementary tasks through the Nili App. All feedback features were fully activated in the Active Nili device.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group: Receiving passive Nili device', 'description': 'Dyad participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Baseline Burden and Stress of Caregivers Over 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group: Care coordination with active Nili System', 'description': 'Participants in the intervention group received the Active Nili system. Essential activities of daily living (ADL) were pre-programmed by a care coordination expert for the Active Nili Care Phase. In addition, patients and their caregivers were able to schedule supplementary tasks through the Nili App. All feedback features were fully activated in the Active Nili device.'}, {'id': 'OG001', 'title': 'Control Group: Receiving passive Nili device', 'description': 'Participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.0', 'spread': '61.9', 'groupId': 'OG000'}, {'value': '-31.9', 'spread': '101.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': "Caregiver burden and stress will be assessed using the 12-item short version of the Zarit Burden Interview (ZBI), a validated survey for dementia caregivers. The ZBI evaluates caregivers' experiences across emotional, physical, and social domains, capturing the strains and difficulties associated with their role. Items address issues such as perceived decline in personal health, the impact of caregiving on relationships with family and friends, and overall feelings of burden. Percentage change from baseline to 3 months will be calculated. Change from baseline burden was reported only for caregivers.\n\nPercentage change on the ZBI-12 can range from -100% (complete resolution of burden) to a large positive increase, with negative values indicating improvement and positive values indicating worsening; reductions of 20% or more are generally considered clinically meaningful improvements.", 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from baseline burden was reported only for caregivers.'}, {'type': 'SECONDARY', 'title': 'Acceptability, Perception of Benefit, and Ease of Use of Care4AD', 'timeFrame': '3 months', 'description': 'This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-10'}, {'type': 'SECONDARY', 'title': 'Change in Baseline Quality of Life at 3 Months: Global PROMIS-10', 'timeFrame': 'Baseline and 3 months', 'description': 'Quality of life will be assessed using a validated questionnaire, called Global PROMIS-10.\n\nThe adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The "7+2" scales include the same global health score plus one fatigue and one pain interference item which are scored independently.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Over 3 Month Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group: Care coordination with active Nili System', 'description': 'Participants in the control group received active Nili system. Essential activity daily living (ADL) tasks will be pre-programmed by our care coordination expert for the Active Nili Care Phase. Patients and their caregivers in the intervention group will be also able to schedule additional tasks.\n\nActive Nili device: Eligible dyads, consisting of individuals with dementia (IWD) and their caregivers, will be randomized in a 1:1 ratio to receive either a 3-month Passive Nili Care device or a 3-month Active Nili Care device. Both devices are identical in design and feature a kiosk-mode interactive tablet that supports IWD in following preprogrammed daily routines, including instrumental activities of daily living (IADLs), social engagement, phone calls, photo sharing, medication adherence, and listening to music or audiobooks. In the Active Nili device, all reminders and programming features will be enabled, whereas in the Passive device, these functions will remain disabled. In both groups, essential ADL tasks will be preprogrammed by a care coordination expert. In addition, the Active Nili system will allow patients and caregivers to schedule personalized tasks through the Nili app.'}, {'id': 'OG001', 'title': 'Control Group: Receiving passive Nili device', 'description': 'Participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.\n\nPassive Nili system: Eligible dyads, consisting of individuals with dementia (IWD) and their caregivers, will be randomized in a 1:1 ratio to receive either a 3-month Passive Nili Care device or a 3-month Active Nili Care device. Both devices are identical in design and feature a kiosk-mode interactive tablet that supports IWD in following preprogrammed daily routines, including instrumental activities of daily living (IADLs), social engagement, phone calls, photo sharing, medication adherence, and listening to music or audiobooks. In the Active Nili device, all reminders and programming features will be enabled, whereas in the Passive device, these functions will remain disabled. In both groups, essential ADL tasks will be preprogrammed by a care coordination expert. In addition, the Active Nili system will allow patients and caregivers to schedule personalized tasks through the Nili app.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 3 month study', 'description': 'Adverse events, including falls, dehydration, urinary tract infections, and emergency department visits, were systematically monitored over a 3-month period. These events were reported exclusively for patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events were reported for patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group: Care coordination with active Nili System', 'description': 'Participants in the intervention group received the Active Nili system. Essential activities of daily living (ADL) were pre-programmed by a care coordination expert for the Active Nili Care Phase. In addition, patients and their caregivers were able to schedule supplementary tasks through the Nili App. All feedback features were fully activated in the Active Nili device.'}, {'id': 'FG001', 'title': 'Control Group: Receiving passive Nili device', 'description': 'Participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The numbers reported in the Participant Flow Milestones represent the number of dyads (individuals with dementia or cognitive impairment and their caregivers). However, the primary outcome is reported only for caregivers, as the focus of this study is on reducing caregiver burden.', 'groupId': 'FG000', 'numSubjects': '28'}, {'comment': 'The numbers reported in the Participant Flow Milestones represent the number of dyads (individuals with dementia or cognitive impairment and their caregivers). However, the primary outcome is reported only for caregivers, as the focus of this study is on reducing caregiver burden.', 'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Number of caregivers', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Number of patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'comment': 'A total of 54 participants completed the study, including 22 (11 caregiver-patient dyads) in the intervention group and 32 (16 caregiver-patient dyads) in the control group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Eligible dyads will consist of individuals with dementia (IWD) and their caregivers. For this study, outcomes related to caregivers will be presented, as the primary endpoint is the reduction of caregiver burden.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group: Care coordination with active Nili System', 'description': 'Dyad participants in the intervention group received the Active Nili system. Essential activities of daily living (ADLs) were preprogrammed by a care coordination expert, and patients and their caregivers could schedule additional tasks through the Nili App. All feedback features were fully activated during the Active Nili Care phase.\n\nThe demographics and caregiver outcomes are presented in this report.'}, {'id': 'BG001', 'title': 'Control Group: Care coordination with passive Nili System', 'description': 'Dyad participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.\n\nThe demographics and caregiver outcomes are presented in this report.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.4', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '53', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '16.3', 'groupId': 'BG002'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.8', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '70.0', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group'}], 'populationDescription': 'A total of 66 participants were recruited, including 28 (14 caregiver-patient dyads) in the intervention group and 38 (19 caregiver-patient dyads) in the control group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-25', 'size': 566916, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-28T16:19', 'hasProtocol': True}, {'date': '2024-01-16', 'size': 91424, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-28T16:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2020-03-10', 'resultsFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-20', 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Baseline Burden and Stress of Caregivers Over 3 Months', 'timeFrame': 'Baseline, 3 months', 'description': "Caregiver burden and stress will be assessed using the 12-item short version of the Zarit Burden Interview (ZBI), a validated survey for dementia caregivers. The ZBI evaluates caregivers' experiences across emotional, physical, and social domains, capturing the strains and difficulties associated with their role. Items address issues such as perceived decline in personal health, the impact of caregiving on relationships with family and friends, and overall feelings of burden. Percentage change from baseline to 3 months will be calculated. Change from baseline burden was reported only for caregivers.\n\nPercentage change on the ZBI-12 can range from -100% (complete resolution of burden) to a large positive increase, with negative values indicating improvement and positive values indicating worsening; reductions of 20% or more are generally considered clinically meaningful improvements."}], 'secondaryOutcomes': [{'measure': 'Acceptability, Perception of Benefit, and Ease of Use of Care4AD', 'timeFrame': '3 months', 'description': 'This will be assessed using technology acceptance model (TAM) survey adopted for telehealth applications'}, {'measure': 'Change in Baseline Quality of Life at 3 Months: Global PROMIS-10', 'timeFrame': 'Baseline and 3 months', 'description': 'Quality of life will be assessed using a validated questionnaire, called Global PROMIS-10.\n\nThe adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The "7+2" scales include the same global health score plus one fatigue and one pain interference item which are scored independently.'}, {'measure': 'Number of Adverse Events Over 3 Month Study', 'timeFrame': 'During the 3 month study', 'description': 'Adverse events, including falls, dehydration, urinary tract infections, and emergency department visits, were systematically monitored over a 3-month period. These events were reported exclusively for patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimber', 'Dementia', 'care coordination'], 'conditions': ['Alzheimer Disease', 'Dementia', 'Dementia Alzheimers']}, 'referencesModule': {'references': [{'pmid': '36096091', 'type': 'RESULT', 'citation': 'Mishra RK, Park C, Momin AS, Rafaei NE, Kunik M, York MK, Najafi B. Care4AD: A Technology-Driven Platform for Care Coordination and Management: Acceptability Study in Dementia. Gerontology. 2023;69(2):227-238. doi: 10.1159/000526219. Epub 2022 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'Dementia, a chronic disease of aging, is characterized by progressive cognitive decline that interferes with independent functioning. The medical, psychological, social and functional sequelae of dementia cause great stress to patients, their caregivers, and their family. The investigator proposes to examine effectiveness of a home-based care coordination and management device, called Care4AD (Nili device) to help caregivers effectively coordinate, manage, and improve dementia care.', 'detailedDescription': 'In this study, the investigator will evaluate the effectiveness of a supportive care coordination device, Care4AD/Nili, in reducing caregiver burden and stress, improving adherence to scheduled tasks, and increasing engagement among individuals with dementia (IWD).\n\nA 3-month randomized controlled trial (RCT) will be conducted with an anticipated 100 caregiver-patient dyads, consisting of 50 individuals with dementia or cognitive impairment and their 50 primary caregivers. Dyads will be randomized in a 1:1 ratio to receive either (1) a Passive Nili device (preprogrammed care coordination with limited daily programmability) for three months, or (2) an Active Nili device for three months. The Active Nili device offers interactive, personalized programming with real-time notifications, task logging, and enhanced social and cognitive engagement features, including photo sharing, phone calls, music, and audiobooks.\n\nThe primary outcome is change in caregiver burden. Secondary outcomes include usability metrics such as perceived ease of use, perceived benefit, technology-related anxiety, and overall attitudes toward adoption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria include:\n\n* Caregivers (\\>18 years old) taking care of older patients (\\> 55 years old) with mild or moderate Alzheimer's Disease or self-reported memory problems and MOCA score of 26 or lower.\n* Must be ambulatory\n* Must be in a residential home with a caregiver/informant.\n\nExclusion Criteria:\n\n* Immobility or inability to engage in activities that are essential for independent living (e.g., patients with severe dementia);\n* Any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study\n* Major hearing/visual impairment;\n* Residing in a nursing home or are receiving hospice care;\n* Inability to communicate in English or Spanish;\n* Unavailability or unwillingness of the caregiver of the patient to attend the interview."}, 'identificationModule': {'nctId': 'NCT04308512', 'briefTitle': 'Care Coordination System for People With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': "A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementia (Care4AD)", 'orgStudyIdInfo': {'id': 'H-46087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group: Care coordination with active Nili System', 'description': 'Participants in the intervention group will receive the Active Nili system. Essential activities of daily living (ADL) were pre-programmed by a care coordination expert for the Active Nili Care Phase. In addition, patients and their caregivers were able to schedule supplementary tasks through the Nili App. All feedback features were fully activated in the Active Nili device.', 'interventionNames': ['Behavioral: Active Nili device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group: Receiving passive Nili device', 'description': 'Participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.', 'interventionNames': ['Behavioral: Passive Nili system']}], 'interventions': [{'name': 'Active Nili device', 'type': 'BEHAVIORAL', 'description': 'Eligible dyads, consisting of individuals with dementia (IWD) and their caregivers, will be randomized in a 1:1 ratio to receive either a 3-month Passive Nili Care device or a 3-month Active Nili Care device. Both devices are identical in design and feature a kiosk-mode interactive tablet that supports IWD in following preprogrammed daily routines, including instrumental activities of daily living (IADLs), social engagement, phone calls, photo sharing, medication adherence, and listening to music or audiobooks. In the Active Nili device, all reminders and programming features will be enabled, whereas in the Passive device, these functions will remain disabled. In both groups, essential ADL tasks will be preprogrammed by a care coordination expert. In addition, the Active Nili system will allow patients and caregivers to schedule personalized tasks through the Nili app.', 'armGroupLabels': ['Intervention Group: Care coordination with active Nili System']}, {'name': 'Passive Nili system', 'type': 'BEHAVIORAL', 'description': 'Eligible dyads, consisting of individuals with dementia (IWD) and their caregivers, will be randomized in a 1:1 ratio to receive either a 3-month Passive Nili Care device or a 3-month Active Nili Care device. Both devices are identical in design and feature a kiosk-mode interactive tablet that supports IWD in following preprogrammed daily routines, including instrumental activities of daily living (IADLs), social engagement, phone calls, photo sharing, medication adherence, and listening to music or audiobooks. In the Active Nili device, all reminders and programming features will be enabled, whereas in the Passive device, these functions will remain disabled. In both groups, essential ADL tasks will be preprogrammed by a care coordination expert. In addition, the Active Nili system will allow patients and caregivers to schedule personalized tasks through the Nili app.', 'armGroupLabels': ['Control Group: Receiving passive Nili device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bijan Najafi, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioSensics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Bijan Najafi, PhD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}