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Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment (SMART)

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
24-week SUDOKU Training Programme
Control Arm (wait-list)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Nursing, LKS Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

24-week SUDOKU Training Programme

wait-list

Arm 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. 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.

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

Outcomes

Primary Outcome Measures

Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
To evaluate various domains of cognition
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
To evaluate various domains of cognition
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
To evaluate various domains of cognition
The digit span-forward and backward test
To measure attention and working memory
The digit span-forward and backward test
To measure attention and working memory
The digit span-forward and backward test
To measure attention and working memory
The list learning delayed recall test
To measure episodic memory
The list learning delayed recall test
To measure episodic memory
The list learning delayed recall test
To measure episodic memory
Trail-Making Test Part A and B
To measure complex attention, executive function and task switching
Trail-Making Test Part A and B
To measure complex attention, executive function and task switching
Trail-Making Test Part A and B
To measure complex attention, executive function and task switching

Secondary Outcome Measures

Memory Inventory for Chinese
To evaluate the subjective memory impairment
Memory Inventory for Chinese
To evaluate the subjective memory impairment
Memory Inventory for Chinese
To evaluate the subjective memory impairment
The 36-item Chinese version of the Short Form 36 (SF-36)
To measure Health-related quality of life in the participants
The 36-item Chinese version of the Short Form 36 (SF-36)
To measure Health-related quality of life in the participants

Full Information

First Posted
April 16, 2021
Last Updated
May 30, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04913857
Brief Title
Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment
Acronym
SMART
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24-week SUDOKU Training Programme
Arm Type
Experimental
Arm 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. 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.
Arm Title
wait-list
Arm Type
Active Comparator
Arm Description
wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes
Intervention Type
Behavioral
Intervention Name(s)
24-week SUDOKU Training Programme
Other Intervention Name(s)
SMART
Intervention Description
12-week face-to-face training session and a 12-week facilitated self-practice
Intervention Type
Other
Intervention Name(s)
Control Arm (wait-list)
Intervention Description
wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes
Primary Outcome Measure Information:
Title
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
To evaluate various domains of cognition
Time Frame
Baseline
Title
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
To evaluate various domains of cognition
Time Frame
12-week
Title
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Description
To evaluate various domains of cognition
Time Frame
24-week
Title
The digit span-forward and backward test
Description
To measure attention and working memory
Time Frame
Baseline
Title
The digit span-forward and backward test
Description
To measure attention and working memory
Time Frame
12-week
Title
The digit span-forward and backward test
Description
To measure attention and working memory
Time Frame
24-week
Title
The list learning delayed recall test
Description
To measure episodic memory
Time Frame
Baseline
Title
The list learning delayed recall test
Description
To measure episodic memory
Time Frame
12-week
Title
The list learning delayed recall test
Description
To measure episodic memory
Time Frame
24-week
Title
Trail-Making Test Part A and B
Description
To measure complex attention, executive function and task switching
Time Frame
Baseline
Title
Trail-Making Test Part A and B
Description
To measure complex attention, executive function and task switching
Time Frame
12-week
Title
Trail-Making Test Part A and B
Description
To measure complex attention, executive function and task switching
Time Frame
24-week
Secondary Outcome Measure Information:
Title
Memory Inventory for Chinese
Description
To evaluate the subjective memory impairment
Time Frame
Baseline
Title
Memory Inventory for Chinese
Description
To evaluate the subjective memory impairment
Time Frame
12-week
Title
Memory Inventory for Chinese
Description
To evaluate the subjective memory impairment
Time Frame
24-week
Title
The 36-item Chinese version of the Short Form 36 (SF-36)
Description
To measure Health-related quality of life in the participants
Time Frame
Baseline
Title
The 36-item Chinese version of the Short Form 36 (SF-36)
Description
To measure Health-related quality of life in the participants
Time Frame
24-week
Other Pre-specified Outcome Measures:
Title
13-item satisfaction survey - for SMART Program
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
Time Frame
12-week
Title
10-item satisfaction survey - for community empowerment-educational campaign
Description
To evaluate the participant's satisfaction towards this service component
Time Frame
10-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doris, Sau Fung Yu, PhD
Phone
+852 39176319
Email
dyu1@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Man Fu, BSocSc
Phone
+852 39176657
Email
po170617@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris, Sau Fung YU, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, LKS Faculty of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris, Sau Fung Yu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only study investigators and research assistants involved in the study will have access to the data.
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Links:
URL
http://www.GlobalCouncilOnBrainHealth.org
Description
Global Council on Brain Health. "Engaging your brain: GCBH recommendations on cognitively stimulating activities."
URL
http://www.thestandard.com.hk
Description
Lam J. Numbers add up for scores of seniors in Sudoku competition.

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Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment

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