Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 7:58 AM
Study NCT ID:
NCT02462135
Status:
COMPLETED
Last Update Posted:
2017-12-15
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol of Virtual Interactive Memory-Training Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).', 'timeFrame': 'Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).', 'timeFrame': 'Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mild cognitive impairment', 'Memory training', 'Randomized controlled study'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '30989165', 'type': 'DERIVED', 'citation': 'Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P, Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age Ageing. 2019 Jul 1;48(4):519-525. doi: 10.1093/ageing/afz029.'}]}, 'descriptionModule': {'briefSummary': 'This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT).', 'detailedDescription': 'This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Virtual interactive memory training, VIMT), or active control group (Passive information activities, PIA). Training sessions of the VIMT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as VIMT group. We constructed a rigorous VIMT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in memory function and degree of depression of older adults with mild cognitive impairment after using the VIMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant\n2. Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms\n3. Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher, and cut-off score of 23/24 on the Montreal Cognitive Assessment (MoCA)\n4. No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family\n\nExclusion Criteria:\n\n1. The clinical diagnosis of dementia was based on the DSM-IV-TR\n2. Active in another cognitive or memory-related training in the past year\n3. Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment\n4. A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible\n5. Severe losses in vision, hearing, or communicative ability'}, 'identificationModule': {'nctId': 'NCT02462135', 'briefTitle': 'Protocol of Virtual Interactive Memory-Training Program', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Science and Technology, Taiwan'}, 'officialTitle': 'The Development and Evaluation of the Effectiveness of a Virtual Interactive Memory Training Program for Older Adults With Mild Cognitive Impairment: Protocol of a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '201301045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual interactive memory training', 'description': 'Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each).', 'interventionNames': ['Behavioral: Virtual interactive memory training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Passive information activities', 'description': 'The training of active control group is the same as VIMT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). The active control group receives only the initial training.', 'interventionNames': ['Behavioral: Passive information activities']}], 'interventions': [{'name': 'Virtual interactive memory training', 'type': 'BEHAVIORAL', 'otherNames': ['Memory training'], 'description': 'Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task.', 'armGroupLabels': ['Virtual interactive memory training']}, {'name': 'Passive information activities', 'type': 'BEHAVIORAL', 'otherNames': ['Active control group'], 'description': 'The active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper.', 'armGroupLabels': ['Passive information activities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22176', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Residential care facilities', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hui-Ling Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University'}, {'name': 'Kuei-Ru Chou, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D. candidate', 'investigatorFullName': 'Yang, Hui-Ling', 'investigatorAffiliation': 'Ministry of Science and Technology, Taiwan'}}}}