Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-11 @ 8:59 AM
Study NCT ID:
NCT02969460
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurotrack Virtual Cognitive Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RBANS score', 'timeFrame': 'week 24', 'description': 'Repeatable Battery for the Assessment of Neuropsychological Status total score'}, {'measure': 'RBANS score', 'timeFrame': 'week 52', 'description': 'Repeatable Battery for the Assessment of Neuropsychological Status total score'}], 'secondaryOutcomes': [{'measure': 'PHQ-9', 'timeFrame': 'week 24', 'description': 'Patient-health questionnaire 9-item scale'}, {'measure': 'PHQ-9', 'timeFrame': 'week 52', 'description': 'Patient-health questionnaire 9-item scale'}, {'measure': 'GAD-7', 'timeFrame': 'week 24', 'description': 'Generalized anxiety disorder 7-item scale'}, {'measure': 'GAD-7', 'timeFrame': 'week 52', 'description': 'Generalized anxiety disorder 7-item scale'}]}, 'conditionsModule': {'conditions': ['Subjective Cognitive Decline']}, 'referencesModule': {'references': [{'pmid': '31518248', 'type': 'DERIVED', 'citation': 'Kumar S, Tran J, Moseson H, Tai C, Glenn JM, Madero EN, Krebs C, Bott N, Juusola JL. The Impact of the Virtual Cognitive Health Program on the Cognition and Mental Health of Older Adults: Pre-Post 12-Month Pilot Study. JMIR Aging. 2018 Nov 9;1(2):e12031. doi: 10.2196/12031.'}, {'pmid': '30104186', 'type': 'DERIVED', 'citation': 'Bott N, Kumar S, Krebs C, Glenn JM, Madero EN, Juusola JL. A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive Health (VC Health) Study. JMIR Res Protoc. 2018 Aug 13;7(8):e11368. doi: 10.2196/11368.'}]}, 'descriptionModule': {'briefSummary': 'The Neurotrack Virtual Cognitive Health Study is a 12-month long, prospective study that aims to evaluate the impact of the Neurotrack Virtual Cognitive Health Coaching Program on cognitive ability, anxiety and depression, and lifestyle behaviors for individuals who show signs of subjective cognitive decline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 60-75\n* Individuals who show signs of subjective cognitive decline (assessed by scoring ≥ 1 on the Subjective Cognitive Decline \\[Short Form\\] Questionnaire and endorsing the Personal Worry Item on the questionnaire)\n* Have the ability to make and receive phone calls\n* Have the ability to send and receive text messages\n* Access to a desktop computer, video-teleconferencing and reliable internet connection\n* Motivated to use a daily coaching program\n\nExclusion Criteria:\n\n* Significant history of mental illness, substance abuse, learning disability, or neurologic conditions\n* History of dementia\n* Ophthalmologic/visual problems that prevent individual from viewing a computer screen at a normal distance (e.g., legal blindness, detached retinas, occlusive cataracts)\n* Currently participating in a formal cognitive-training coaching program\n* Currently pregnant'}, 'identificationModule': {'nctId': 'NCT02969460', 'briefTitle': 'Neurotrack Virtual Cognitive Health Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evidation Health'}, 'orgStudyIdInfo': {'id': 'EH-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurotrack Virtual Cognitive Health Program', 'description': 'This program is a multi-domain lifestyle intervention designed to prevent or delay cognitive decline and impairment in older at-risk adults. The first 6 months of the program emphasizes lifestyle change, while the last 6 months of the program emphasizes habit reinforcement. The program focuses on nutrition, physical exercise, and cognitive training.', 'interventionNames': ['Behavioral: Neurotrack Virtual Cognitive Health Program']}], 'interventions': [{'name': 'Neurotrack Virtual Cognitive Health Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Neurotrack Virtual Cognitive Health Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94401', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Evidation Health', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evidation Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Neurotrack', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}