Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT04489303
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2020-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Virtual Patient Behavioral Response Training for Family Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'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': 'info@photozig.com', 'phone': '6506947496', 'title': 'Bruno Kajiyama', 'organization': 'Photozig, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'The definitions are the same as the ones from clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.\n\nCaring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Educational Training', 'description': 'Traditional educational program.\n\nTraditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Revised Memory and Behavior Problems Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.\n\nCaring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.'}, {'id': 'OG001', 'title': 'Educational Training', 'description': 'Traditional educational program.\n\nTraditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Center for Epidemiological Studies Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.\n\nCaring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.'}, {'id': 'OG001', 'title': 'Educational Training', 'description': 'Traditional educational program.\n\nTraditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.84', 'spread': '9.97', 'groupId': 'OG000'}, {'value': '21.00', 'spread': '11.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.\n\nCaring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.'}, {'id': 'OG001', 'title': 'Educational Training', 'description': 'Traditional educational program.\n\nTraditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.78', 'spread': '6.23', 'groupId': 'OG000'}, {'value': '19.01', 'spread': '7.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.\n\nCaring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.'}, {'id': 'FG001', 'title': 'Educational Training', 'description': 'Traditional educational program.\n\nTraditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.\n\nCaring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.'}, {'id': 'BG001', 'title': 'Educational Training', 'description': 'Traditional educational program.\n\nTraditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-13', 'size': 99094, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-16T22:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2020-07-24', 'resultsFirstSubmitDate': '2022-05-14', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-16', 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised Memory and Behavior Problems Checklist', 'timeFrame': '3 months', 'description': 'This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.'}, {'measure': 'Center for Epidemiological Studies Depression Scale', 'timeFrame': '3 months', 'description': 'The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': '3 months', 'description': 'The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.", 'detailedDescription': "The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Care for an individual with Alzheimer's Disease or other dementia.\n* Own a smartphone or tablet and have Internet access.\n* Minimum age of 18 years old.\n* Spend at least 8 hours/week caring for a person with dementia.\n\nExclusion Criteria:\n\n* Severe psychological or physical illness.\n* Inability to read and follow English instructions.\n* High level of depressive symptoms.\n* Unwillingness to participate in all aspects of the study."}, 'identificationModule': {'nctId': 'NCT04489303', 'briefTitle': 'Virtual Patient Behavioral Response Training for Family Caregivers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Photozig, Inc.'}, 'officialTitle': 'Virtual Patient Behavioral Response Training for Family Caregivers', 'orgStudyIdInfo': {'id': 'Pz-A107a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Patient Behavioral Response Training', 'description': 'Caring Response mobile app with a behavioral training.', 'interventionNames': ['Behavioral: Caring Response App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Training', 'description': 'Traditional educational program.', 'interventionNames': ['Behavioral: Traditional Educational/Resources Program']}], 'interventions': [{'name': 'Caring Response App', 'type': 'BEHAVIORAL', 'description': 'Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.', 'armGroupLabels': ['Virtual Patient Behavioral Response Training']}, {'name': 'Traditional Educational/Resources Program', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a traditional educational/resources program, containing a workbook and online resources.', 'armGroupLabels': ['Educational Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94035-0128', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Photozig, Inc.', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Bruno Kajiyama, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Photozig, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Photozig, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}