Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04413851
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2020-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Passive Data Collection in Dementia Subjects With Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D000093902', 'term': 'Mixed Dementias'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data.', 'timeFrame': '28 days', 'description': 'Comparison of data collected from the smartphone and wearable device to episodes identified by subject or caregiver assessment:\n\n1. Cleaned single channel data compared to assessments\n2. Cleaned multichannel data compared to assessments\n3. Analyzed multichannel data compared to assessments\n4. Subject/Caregiver assessment data compared to agitation scale ratings\n5. Agitation scale ratings compared to cleaned single and multichannel data and analyzed multichannel data.\n6. Merged subject/caregiver assessment and multichannel data compared to agitation scale ratings'}], 'primaryOutcomes': [{'measure': 'Feasibility of passive and continuous data collection', 'timeFrame': '28 days', 'description': 'Total time and percentage of continuous data collection for each stream of data aiming for \\>50% coverage.'}], 'secondaryOutcomes': [{'measure': 'Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior.', 'timeFrame': '28 days', 'description': 'Caregiver and Staff engagement with the eCOA and EMA (threshold 80% completion) and responses to usability questionnaires at week 1 and 4 to provide feedback on comfort, usability and engagement. The score ranges from 10 to 50, higher score indicating a better usability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Alzheimer Disease', 'Vascular Dementia', 'Frontotemporal Dementia', 'Lewy Body Dementia', 'Mixed Dementia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch).\n\nThe purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible individuals who have a diagnosis of dementia and a recent history of agitation will sign an informed consent, with a legally authorized representative (LAR) when necessary, to enroll in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects 18 years and older.\n* Subjects who have met DSM-5 criteria for Dementia (all cause)\n* Subjects with a recent history of agitation in the past 6 months to a point that impairs social activities, requires staffing or medical intervention (kick, bite, flailing, etc.), impairs ability for functional activities of daily living, as disclosed by a caregiver or documented in the medical record.\n* Subjects resident in a group home, nursing home, or assisted living are eligible to participate.\n* Subjects who can read, understand and provide written informed consent or who have a Legally Acceptable Representative (LAR)\n* Subjects who are willing and able to carry a smartphone and wear an activity tracker on their wrist or hand, alone or with the help of a caregiver.\n* Subjects who, either alone or with a caregiver, are able to operate a smartphone and wrist or hand-worn activity tracker, alone or with the help of a caregiver.\n* Subjects who are in good general health prior to study participation as determined by a detailed medical history, and in the opinion of the Principal Investigator.\n* Subjects, who are able to ambulate without an assistive device, or with a single point cane.\n\nExclusion Criteria:\n\n* Subjects who are unwilling or unable to carry a smartphone and wear an activity tracker on their wrist or hand.\n* Subjects with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic or hematologic disease.\n* Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate.'}, 'identificationModule': {'nctId': 'NCT04413851', 'briefTitle': 'Feasibility of Passive Data Collection in Dementia Subjects With Agitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'HealthMode Inc.'}, 'officialTitle': 'A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia', 'orgStudyIdInfo': {'id': 'HM060401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dementia', 'description': 'Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Neuroscience Research, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Virtual Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthMode Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}