Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 7:11 AM
Study NCT ID:
NCT04913857
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment
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': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-30', 'size': 121198, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-16T12:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To implement a SMART Program to promote cognitive health among patients with MCI, and the use of active mind strategy in preventing dementia among the older adults'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-07', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '13-item satisfaction survey - for SMART Program', 'timeFrame': '12-week', 'description': "To evaluate the participant's satisfaction towards the Sudoku program including acceptability, applicability to promote brain health and psychosocial health, accessibility and level of support"}, {'measure': '10-item satisfaction survey - for community empowerment-educational campaign', 'timeFrame': '10-month', 'description': "To evaluate the participant's satisfaction towards this service component"}], 'primaryOutcomes': [{'measure': "Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)", 'timeFrame': 'Baseline', 'description': 'To evaluate various domains of cognition'}, {'measure': "Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)", 'timeFrame': '12-week', 'description': 'To evaluate various domains of cognition'}, {'measure': "Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)", 'timeFrame': '24-week', 'description': 'To evaluate various domains of cognition'}, {'measure': 'The digit span-forward and backward test', 'timeFrame': 'Baseline', 'description': 'To measure attention and working memory'}, {'measure': 'The digit span-forward and backward test', 'timeFrame': '12-week', 'description': 'To measure attention and working memory'}, {'measure': 'The digit span-forward and backward test', 'timeFrame': '24-week', 'description': 'To measure attention and working memory'}, {'measure': 'The list learning delayed recall test', 'timeFrame': 'Baseline', 'description': 'To measure episodic memory'}, {'measure': 'The list learning delayed recall test', 'timeFrame': '12-week', 'description': 'To measure episodic memory'}, {'measure': 'The list learning delayed recall test', 'timeFrame': '24-week', 'description': 'To measure episodic memory'}, {'measure': 'Trail-Making Test Part A and B', 'timeFrame': 'Baseline', 'description': 'To measure complex attention, executive function and task switching'}, {'measure': 'Trail-Making Test Part A and B', 'timeFrame': '12-week', 'description': 'To measure complex attention, executive function and task switching'}, {'measure': 'Trail-Making Test Part A and B', 'timeFrame': '24-week', 'description': 'To measure complex attention, executive function and task switching'}], 'secondaryOutcomes': [{'measure': 'Memory Inventory for Chinese', 'timeFrame': 'Baseline', 'description': 'To evaluate the subjective memory impairment'}, {'measure': 'Memory Inventory for Chinese', 'timeFrame': '12-week', 'description': 'To evaluate the subjective memory impairment'}, {'measure': 'Memory Inventory for Chinese', 'timeFrame': '24-week', 'description': 'To evaluate the subjective memory impairment'}, {'measure': 'The 36-item Chinese version of the Short Form 36 (SF-36)', 'timeFrame': 'Baseline', 'description': 'To measure Health-related quality of life in the participants'}, {'measure': 'The 36-item Chinese version of the Short Form 36 (SF-36)', 'timeFrame': '24-week', 'description': 'To measure Health-related quality of life in the participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '23776645', 'type': 'BACKGROUND', 'citation': 'Wu YT, Lee HY, Norton S, Chen C, Chen H, He C, Fleming J, Matthews FE, Brayne C. Prevalence studies of dementia in mainland china, Hong Kong and taiwan: a systematic review and meta-analysis. PLoS One. 2013 Jun 11;8(6):e66252. doi: 10.1371/journal.pone.0066252. Print 2013.'}, {'pmid': '17892609', 'type': 'BACKGROUND', 'citation': 'Lam LC, Tam CW, Lui VW, Chan WC, Chan SS, Wong S, Wong A, Tham MK, Ho KS, Chan WM, Chiu HF. Prevalence of very mild and mild dementia in community-dwelling older Chinese people in Hong Kong. Int Psychogeriatr. 2008 Feb;20(1):135-48. doi: 10.1017/S1041610207006199. Epub 2007 Sep 25.'}, {'pmid': '27489876', 'type': 'BACKGROUND', 'citation': 'Ding D, Zhao Q, Guo Q, Liang X, Luo J, Yu L, Zheng L, Hong Z; Shanghai Aging Study (SAS). Progression and predictors of mild cognitive impairment in Chinese elderly: A prospective follow-up in the Shanghai Aging Study. Alzheimers Dement (Amst). 2016 Apr 9;4:28-36. doi: 10.1016/j.dadm.2016.03.004. eCollection 2016.'}, {'pmid': '24656834', 'type': 'BACKGROUND', 'citation': 'Wirth M, Haase CM, Villeneuve S, Vogel J, Jagust WJ. Neuroprotective pathways: lifestyle activity, brain pathology, and cognition in cognitively normal older adults. Neurobiol Aging. 2014 Aug;35(8):1873-82. doi: 10.1016/j.neurobiolaging.2014.02.015. Epub 2014 Feb 20.'}, {'pmid': '25143069', 'type': 'BACKGROUND', 'citation': 'Reuter-Lorenz PA, Park DC. How does it STAC up? Revisiting the scaffolding theory of aging and cognition. Neuropsychol Rev. 2014 Sep;24(3):355-70. doi: 10.1007/s11065-014-9270-9. Epub 2014 Aug 21.'}, {'pmid': '29282641', 'type': 'BACKGROUND', 'citation': 'Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.'}, {'pmid': '21876829', 'type': 'BACKGROUND', 'citation': 'Tardif S, Simard M. Cognitive stimulation programs in healthy elderly: a review. Int J Alzheimers Dis. 2011;2011:378934. doi: 10.4061/2011/378934. Epub 2011 Aug 15.'}, {'pmid': '30443984', 'type': 'BACKGROUND', 'citation': 'Brooker H, Wesnes KA, Ballard C, Hampshire A, Aarsland D, Khan Z, Stenton R, McCambridge L, Corbett A. An online investigation of the relationship between the frequency of word puzzle use and cognitive function in a large sample of older adults. Int J Geriatr Psychiatry. 2019 Jul;34(7):921-931. doi: 10.1002/gps.5033. Epub 2019 May 16.'}, {'pmid': '25358750', 'type': 'BACKGROUND', 'citation': "Schultz SA, Larson J, Oh J, Koscik R, Dowling MN, Gallagher CL, Carlsson CM, Rowley HA, Bendlin BB, Asthana S, Hermann BP, Johnson SC, Sager M, LaRue A, Okonkwo OC. Participation in cognitively-stimulating activities is associated with brain structure and cognitive function in preclinical Alzheimer's disease. Brain Imaging Behav. 2015 Dec;9(4):729-36. doi: 10.1007/s11682-014-9329-5."}, {'pmid': '22040899', 'type': 'BACKGROUND', 'citation': 'Pillai JA, Hall CB, Dickson DW, Buschke H, Lipton RB, Verghese J. Association of crossword puzzle participation with memory decline in persons who develop dementia. J Int Neuropsychol Soc. 2011 Nov;17(6):1006-13. doi: 10.1017/S1355617711001111.'}, {'pmid': '24989949', 'type': 'BACKGROUND', 'citation': 'Ferreira N, Owen A, Mohan A, Corbett A, Ballard C. Associations between cognitively stimulating leisure activities, cognitive function and age-related cognitive decline. Int J Geriatr Psychiatry. 2015 Apr;30(4):422-30. doi: 10.1002/gps.4155. Epub 2014 Jul 3.'}, {'pmid': '11056778', 'type': 'BACKGROUND', 'citation': "Chu LW, Chiu KC, Hui SL, Yu GK, Tsui WJ, Lee PW. The reliability and validity of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) among the elderly Chinese in Hong Kong. Ann Acad Med Singap. 2000 Jul;29(4):474-85."}, {'pmid': '16927409', 'type': 'BACKGROUND', 'citation': "Lui VW, Lam LC, Chiu HF. Validation of a memory inventory for the assessment of awareness of memory deficits in Alzheimer's disease in Chinese elderly. Int J Geriatr Psychiatry. 2006 Oct;21(10):917-23. doi: 10.1002/gps.1580."}, {'pmid': '9817131', 'type': 'BACKGROUND', 'citation': 'Lam CL, Gandek B, Ren XS, Chan MS. Tests of scaling assumptions and construct validity of the Chinese (HK) version of the SF-36 Health Survey. J Clin Epidemiol. 1998 Nov;51(11):1139-47. doi: 10.1016/s0895-4356(98)00105-x.'}, {'pmid': '15831139', 'type': 'BACKGROUND', 'citation': 'Rabiee F. Focus-group interview and data analysis. Proc Nutr Soc. 2004 Nov;63(4):655-60. doi: 10.1079/pns2004399.'}], 'seeAlsoLinks': [{'url': 'http://www.GlobalCouncilOnBrainHealth.org', 'label': 'Global Council on Brain Health. "Engaging your brain: GCBH recommendations on cognitively stimulating activities."'}, {'url': 'http://www.thestandard.com.hk', 'label': 'Lam J. Numbers add up for scores of seniors in Sudoku competition.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to implement a SUDOKU Mind Activation and Revitalization Training (SMART) Program to promote cognitive health among patients with mild cognitive impairment (MCI), and the use of active mind strategy in preventing dementia among the older adults. The SMART Program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week SUDOKU Training Programme for people with MCI.', 'detailedDescription': 'This study aims to implement a SMART Program to promote cognitive health among patients with MCI, and the use of active mind strategy in preventing dementia among the older adults. The SMART Program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week SUDOKU Training Programme for people with MCI.\n\nThe community empowerment-educational campaign will be conducted in the elderly care centres of the two collaborating non-governmental organizations, with the purpose of increasing the awareness of people aged 55 or above on the importance of maintaining an active mind and preventing age-related cognitive decline and dementia. The campaign will include cognitive screening, poster exhibition, booth exhibition and individual counselling.\n\nThe SUDOKU training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. The face-to-face sessions aim at developing the skills of the participants in solving the SUDOKU using the T-code. The 12-week training program will be evenly divided into three modules of increasing difficulty, with consideration given to the suboptimal cognitive function of the participants with MCI. These modules are developed by the Co-investigator who has rich prior experience in teaching older adults on SUDOKU puzzle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with MCI as defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment in the general public and aged 55 or above.\n\nExclusion Criteria:\n\n* Persons with dementia and communication problems will be excluded.'}, 'identificationModule': {'nctId': 'NCT04913857', 'acronym': 'SMART', 'briefTitle': 'Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'New Wine in Old Bottle: the Effects of SUDOKU Mind Activation and Revitalizing Training (SMART) Program on Cognitive Function Among People With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'SMART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24-week SUDOKU Training Programme', 'description': 'The SUDOKU training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. The 12-week (60-minute sessions) training program will be evenly divided into 3 modules of increasing difficulty for the suboptimal cognitive function of the participants with MCI. As the use of T-code in solving the SUDOKU allows communicating the way a number is assigned to a box, participants are grouped into a small team of 3, so that they will work together during the tutorial practice.\n\nFacilitated self-practice will last for another 12 weeks immediately after the group training session. The instructor will give them a workbook with 12 SUDOKU puzzles of increasing level of difficulty for completion. The instructor will encourage and facilitate their accomplishment by giving them guidance on the taught method through regular phone call. Solutions of the assigned puzzle and the T-code will be provided in the following week.', 'interventionNames': ['Behavioral: 24-week SUDOKU Training Programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'wait-list', 'description': 'wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes', 'interventionNames': ['Other: Control Arm (wait-list)']}], 'interventions': [{'name': '24-week SUDOKU Training Programme', 'type': 'BEHAVIORAL', 'otherNames': ['SMART'], 'description': '12-week face-to-face training session and a 12-week facilitated self-practice', 'armGroupLabels': ['24-week SUDOKU Training Programme']}, {'name': 'Control Arm (wait-list)', 'type': 'OTHER', 'description': 'wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes', 'armGroupLabels': ['wait-list']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Medicine and Geriatrics, United Christian Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Doris, Sau Fung YU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only study investigators and research assistants involved in the study will have access to the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Yu, Doris Sau Fung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}