Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 6:10 AM
Study NCT ID:
NCT03190460
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating Technology-Based Fall Prevention Interventions
Sponsor:
Organization:
Raw JSON
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Subjects complete 3 training sessions per week with at least 24 hours in between sessions.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education', 'description': 'Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Falls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.'}, {'id': 'OG001', 'title': 'Education', 'description': 'Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Falls and Injurious Falls as per Fall Calendar', 'unitOfMeasure': 'number of falls', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disability', 'timeFrame': '8 weeks, 16 weeks, 20 weeks.', 'description': 'Gill Disability Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cognitive Assessment', 'timeFrame': '8 weeks, 16 weeks, 20 weeks', 'description': 'CANTAB Battery (Simple response time, one touch stockings of Cambridge, Stop Signal Task, Spatial Working Memory, Verbal Recognition Memory, Rapid Visual Information Processing)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Gait Assessment', 'timeFrame': '8 weeks, 16 weeks, 20 weeks', 'description': 'Assessment of Gait Parameters using APDM sensor system', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Balance Assessment', 'timeFrame': '8 weeks, 16 weeks, 20 weeks', 'description': 'Assessment of Balance using APDM sensor system', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.'}, {'id': 'FG001', 'title': 'Education', 'description': 'Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.'}, {'id': 'BG001', 'title': 'Education', 'description': 'Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.'}, {'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '75.9', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '76.8', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '58', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-27', 'size': 251954, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-29T16:28', 'hasProtocol': True}, {'date': '2018-06-06', 'size': 84519, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-26T22:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2017-06-13', 'resultsFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-29', 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Falls', 'timeFrame': '16 weeks', 'description': 'Falls and Injurious Falls as per Fall Calendar'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': '8 weeks, 16 weeks, 20 weeks.', 'description': 'Gill Disability Scale'}, {'measure': 'Cognitive Assessment', 'timeFrame': '8 weeks, 16 weeks, 20 weeks', 'description': 'CANTAB Battery (Simple response time, one touch stockings of Cambridge, Stop Signal Task, Spatial Working Memory, Verbal Recognition Memory, Rapid Visual Information Processing)'}, {'measure': 'Gait Assessment', 'timeFrame': '8 weeks, 16 weeks, 20 weeks', 'description': 'Assessment of Gait Parameters using APDM sensor system'}, {'measure': 'Balance Assessment', 'timeFrame': '8 weeks, 16 weeks, 20 weeks', 'description': 'Assessment of Balance using APDM sensor system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Falls (Accidents) in Old Age']}, 'referencesModule': {'references': [{'pmid': '31451566', 'type': 'BACKGROUND', 'citation': 'Thompson HJ, McGough E, Demiris G. Falls and Cognitive Training 2 (FaCT2) study protocol: a randomised controlled trial exploring cognitive training to reduce risk of falls in at-risk older adults. Inj Prev. 2020 Aug;26(4):370-377. doi: 10.1136/injuryprev-2019-043332. Epub 2019 Aug 26.'}, {'pmid': '39360568', 'type': 'DERIVED', 'citation': 'Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Approximately one in three older adults fall annually and it is the primary cause of traumatic injury in older adults. While exercise and balance programs have been shown to be effective in reducing fall risk, maintaining behavior change is known to be difficult. Thus additional interventions need to be validated to add to our current armamentarium to reduce falls in older adults. Cognitive training (CT) involves exercises that target specific cognitive tasks, such as memory or processing speed. It has been speculated that routinely performing such tasks may increase functional ability. Recent work has pointed to an increased risk of falls in community-dwelling older adults who have alterations in specific cognitive tasks. Thus the purpose of the proposed study is to demonstrate the feasibility and to explore the effectiveness of a 16 week CT intervention to reduce risk and incidence of fall and improve outcomes up to 1 month post-intervention in a group of community dwelling older adults at risk for fall.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65-89 years old\n* speak and read English\n* live within 30 miles of the University of Washington\n* a score of 4 or higher on the Memory Impairment Screen (MIS-T)\n* regular access to a computer with internet capability (whether at home, friend/family, community center, public library, or other)\n* a positive response to any of the following three fall related questions: i) Have you had two or more falls in the prior 12 months? ii) Are you responding to the advertisement because of a recent fall? iii) Do you have difficulty with walking or balance?\n* \\<53 seconds on 90 second balance test or gait speed \\<1m/sec.\n\nExclusion Criteria:\n\n* current participation in formal cognitive training program\n* currently bedridden or wheelchair dependent'}, 'identificationModule': {'nctId': 'NCT03190460', 'acronym': 'FaCT2', 'briefTitle': 'Evaluating Technology-Based Fall Prevention Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Influence of Cognitive Training on Fall Prevention in At Risk Older Adults', 'orgStudyIdInfo': {'id': '50219'}, 'secondaryIdInfos': [{'id': 'R21NR015541', 'link': 'https://reporter.nih.gov/quickSearch/R21NR015541', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: Cognitive Training']}, {'type': 'OTHER', 'label': 'Education', 'interventionNames': ['Other: Technology-based Education']}], 'interventions': [{'name': 'Cognitive Training', 'type': 'OTHER', 'description': 'Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.', 'armGroupLabels': ['Intervention']}, {'name': 'Technology-based Education', 'type': 'OTHER', 'description': 'Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Hilaire Thompson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hilaire Thompson', 'investigatorAffiliation': 'University of Washington'}}}}