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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04913857
Other study ID # SMART
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. The 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. The 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.


Recruitment information / eligibility

Status Completed
Enrollment 262
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Persons with dementia and communication problems will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
24-week SUDOKU Training Programme
12-week face-to-face training session and a 12-week facilitated self-practice
Other:
Control Arm (wait-list)
wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes

Locations

Country Name City State
Hong Kong Department of Medicine and Geriatrics, United Christian Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Rabiee F. Focus-group interview and data analysis. Proc Nutr Soc. 2004 Nov;63(4):655-60. doi: 10.1079/pns2004399. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other 13-item satisfaction survey - for SMART Program 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 12-week
Other 10-item satisfaction survey - for community empowerment-educational campaign To evaluate the participant's satisfaction towards this service component 10-month
Primary Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) To evaluate various domains of cognition Baseline
Primary Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) To evaluate various domains of cognition 12-week
Primary Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) To evaluate various domains of cognition 24-week
Primary The digit span-forward and backward test To measure attention and working memory Baseline
Primary The digit span-forward and backward test To measure attention and working memory 12-week
Primary The digit span-forward and backward test To measure attention and working memory 24-week
Primary The list learning delayed recall test To measure episodic memory Baseline
Primary The list learning delayed recall test To measure episodic memory 12-week
Primary The list learning delayed recall test To measure episodic memory 24-week
Primary Trail-Making Test Part A and B To measure complex attention, executive function and task switching Baseline
Primary Trail-Making Test Part A and B To measure complex attention, executive function and task switching 12-week
Primary Trail-Making Test Part A and B To measure complex attention, executive function and task switching 24-week
Secondary Memory Inventory for Chinese To evaluate the subjective memory impairment Baseline
Secondary Memory Inventory for Chinese To evaluate the subjective memory impairment 12-week
Secondary Memory Inventory for Chinese To evaluate the subjective memory impairment 24-week
Secondary The 36-item Chinese version of the Short Form 36 (SF-36) To measure Health-related quality of life in the participants Baseline
Secondary The 36-item Chinese version of the Short Form 36 (SF-36) To measure Health-related quality of life in the participants 24-week
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