Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT05990335
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2023-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Boost Study 21270 (Cognition)
Sponsor:
Organization:
Raw JSON
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'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognition Exercises Group C', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Task Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognition Exercises Group I', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}, {'id': 'OG001', 'title': 'Cognition Exercises Group C', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '15', 'groupId': 'OG000'}, {'value': '57', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 8 weeks', 'description': 'Percentage of participants completing minimum required weekly interactions', 'unitOfMeasure': 'Percentage of eligible participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Task Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognition Exercises Group I', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}, {'id': 'OG001', 'title': 'Cognition Exercises Group C', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 8 weeks', 'description': 'Change in Human Hypothetical Choice scale (higher scores indicate a better outcome, minimum value 0 to maximum value 1), calculated as value at 8 weeks minus value at 1 week', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup of participants in each arm completing all study weeks and requested activities, were analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognition Exercises Group I', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}, {'id': 'FG001', 'title': 'Cognition Exercises Group C', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognition Exercises Group I', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}, {'id': 'BG001', 'title': 'Cognition Exercises Group C', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions\n\nmHealth application (custom): Smartphone based application designed to engage user executive functions'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Transgender Male or Transgender Female', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Black / African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Unreported', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Units are participants are population is same as assignment in Participant Flow'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-17', 'size': 527936, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-15T14:17', 'hasProtocol': True}, {'date': '2022-04-17', 'size': 590685, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-15T14:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-15', 'studyFirstSubmitDate': '2023-07-31', 'resultsFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2023-08-05', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-15', 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Task Completion Rate', 'timeFrame': 'At 8 weeks', 'description': 'Percentage of participants completing minimum required weekly interactions'}], 'secondaryOutcomes': [{'measure': 'Change in Task Performance', 'timeFrame': 'At 8 weeks', 'description': 'Change in Human Hypothetical Choice scale (higher scores indicate a better outcome, minimum value 0 to maximum value 1), calculated as value at 8 weeks minus value at 1 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognition'], 'conditions': ['Cognitive Function Abnormal']}, 'descriptionModule': {'briefSummary': 'This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.', 'detailedDescription': 'The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and above\n* Fluent in English\n* Resides in the United States\n* Score on prescreen task is in 25% quartile\n* Familiar with smartphone device app installation and device usage\n* Possesses a compatible smartphone\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05990335', 'briefTitle': 'Boost Study 21270 (Cognition)', 'organization': {'class': 'INDUSTRY', 'fullName': 'NXTech'}, 'officialTitle': 'Mobile Software Application Intervention Including Cognitive Tasks', 'orgStudyIdInfo': {'id': 'NX-21270'}, 'secondaryIdInfos': [{'id': 'R43DA051270', 'link': 'https://reporter.nih.gov/quickSearch/R43DA051270', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognition exercises group I', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions', 'interventionNames': ['Behavioral: mHealth application (custom)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognition exercises group C', 'description': 'Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions', 'interventionNames': ['Behavioral: mHealth application (custom)']}], 'interventions': [{'name': 'mHealth application (custom)', 'type': 'BEHAVIORAL', 'description': 'Smartphone based application designed to engage user executive functions', 'armGroupLabels': ['Cognition exercises group C', 'Cognition exercises group I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66506', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas State DPS', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'overallOfficials': [{'name': 'Travis Smith', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kansas State'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NXTech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kansas State University', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}