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

January 7, 2024 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine and Geriatrics, United Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24-week SUDOKU Training Programme

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
12-week face-to-face training session and a 12-week facilitated self-practice
Other Names:
  • SMART
Active Comparator: wait-list
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)
wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time Frame: Baseline
To evaluate various domains of cognition
Baseline
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time Frame: 12-week
To evaluate various domains of cognition
12-week
Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time Frame: 24-week
To evaluate various domains of cognition
24-week
The digit span-forward and backward test
Time Frame: Baseline
To measure attention and working memory
Baseline
The digit span-forward and backward test
Time Frame: 12-week
To measure attention and working memory
12-week
The digit span-forward and backward test
Time Frame: 24-week
To measure attention and working memory
24-week
The list learning delayed recall test
Time Frame: Baseline
To measure episodic memory
Baseline
The list learning delayed recall test
Time Frame: 12-week
To measure episodic memory
12-week
The list learning delayed recall test
Time Frame: 24-week
To measure episodic memory
24-week
Trail-Making Test Part A and B
Time Frame: Baseline
To measure complex attention, executive function and task switching
Baseline
Trail-Making Test Part A and B
Time Frame: 12-week
To measure complex attention, executive function and task switching
12-week
Trail-Making Test Part A and B
Time Frame: 24-week
To measure complex attention, executive function and task switching
24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memory Inventory for Chinese
Time Frame: Baseline
To evaluate the subjective memory impairment
Baseline
Memory Inventory for Chinese
Time Frame: 12-week
To evaluate the subjective memory impairment
12-week
Memory Inventory for Chinese
Time Frame: 24-week
To evaluate the subjective memory impairment
24-week
The 36-item Chinese version of the Short Form 36 (SF-36)
Time Frame: Baseline
To measure Health-related quality of life in the participants
Baseline
The 36-item Chinese version of the Short Form 36 (SF-36)
Time Frame: 24-week
To measure Health-related quality of life in the participants
24-week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
13-item satisfaction survey - for SMART Program
Time Frame: 12-week
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
10-item satisfaction survey - for community empowerment-educational campaign
Time Frame: 10-month
To evaluate the participant's satisfaction towards this service component
10-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Doris, Sau Fung YU, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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