NCT04913857

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

April 16, 2021

Last Update Submit

January 7, 2024

Conditions

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (12)

  • Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    To evaluate various domains of cognition

    Baseline

  • Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    To evaluate various domains of cognition

    12-week

  • Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

    To evaluate various domains of cognition

    24-week

  • The digit span-forward and backward test

    To measure attention and working memory

    Baseline

  • The digit span-forward and backward test

    To measure attention and working memory

    12-week

  • The digit span-forward and backward test

    To measure attention and working memory

    24-week

  • The list learning delayed recall test

    To measure episodic memory

    Baseline

  • The list learning delayed recall test

    To measure episodic memory

    12-week

  • The list learning delayed recall test

    To measure episodic memory

    24-week

  • Trail-Making Test Part A and B

    To measure complex attention, executive function and task switching

    Baseline

  • Trail-Making Test Part A and B

    To measure complex attention, executive function and task switching

    12-week

  • Trail-Making Test Part A and B

    To measure complex attention, executive function and task switching

    24-week

Secondary Outcomes (5)

  • Memory Inventory for Chinese

    Baseline

  • Memory Inventory for Chinese

    12-week

  • Memory Inventory for Chinese

    24-week

  • The 36-item Chinese version of the Short Form 36 (SF-36)

    Baseline

  • The 36-item Chinese version of the Short Form 36 (SF-36)

    24-week

Other Outcomes (2)

  • 13-item satisfaction survey - for SMART Program

    12-week

  • 10-item satisfaction survey - for community empowerment-educational campaign

    10-month

Study Arms (2)

24-week SUDOKU Training Programme

EXPERIMENTAL

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. Facilitated 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.

Behavioral: 24-week SUDOKU Training Programme

wait-list

ACTIVE COMPARATOR

wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes

Other: Control Arm (wait-list)

Interventions

12-week face-to-face training session and a 12-week facilitated self-practice

Also known as: SMART
24-week SUDOKU Training Programme

wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes

wait-list

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Persons with dementia and communication problems will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine and Geriatrics, United Christian Hospital

Hong Kong, Hong Kong

Location

Related Publications (15)

  • 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: 23776645BACKGROUND
  • 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: 17892609BACKGROUND
  • 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: 27489876BACKGROUND
  • 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: 24656834BACKGROUND
  • 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: 25143069BACKGROUND
  • 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: 29282641BACKGROUND
  • 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: 21876829BACKGROUND
  • 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: 30443984BACKGROUND
  • 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: 25358750BACKGROUND
  • 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: 22040899BACKGROUND
  • 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: 24989949BACKGROUND
  • 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: 11056778BACKGROUND
  • 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: 16927409BACKGROUND
  • 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: 9817131BACKGROUND
  • Rabiee F. Focus-group interview and data analysis. Proc Nutr Soc. 2004 Nov;63(4):655-60. doi: 10.1079/pns2004399.

    PMID: 15831139BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Doris, Sau Fung YU, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

June 4, 2021

Study Start

September 15, 2020

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Only study investigators and research assistants involved in the study will have access to the data.

Locations