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Board Game Intervention to Improve Cognitive and Daily Functioning

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Board game intervention
Sponsored by
Yang Shang-Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 88 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 65 years or older without a diagnosis of dementia
  • mild neurocognitive impairment

Exclusion Criteria:

  • non-national senior citizens
  • unable to understand the content and complete the questionnaire
  • unable to participate in the full 12-week intervention
  • had an acute illness such as a cold during the trial.

Sites / Locations

  • Asia Univeraity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Board game group

Health promotion group

Arm Description

The Board game group was led by an occupational therapist who has been working for six years. The intervention comprised 1 week of board game instruction and 11 weeks of board game tasks (combined with daily tasks), for a total of 12 weeks, once a week for 2 hours, for a total of 24 hours of intervention.

MCI seniors in the health promotion group received general health promotion and were led by instructors from the long-term care facility for 12 weeks, including 4 weeks of physical activities, 4 weeks of singing activities, and 4 weeks of art activities, once a week for 2 hours, for a total of 24 hours.

Outcomes

Primary Outcome Measures

Saint Louis University Mental Status Exam (SLUMSE)
SLUMSE was used to evaluate the cognitive function of MCI seniors. SLUMSE is the most popular cognitive screening tool used worldwide to detect patients with dementia and MCI. The scale is comprised of four domains: orientation (e.g., day, year, and place; three questions), memory (e.g., remembering five things; one question), attention (e.g., story review; one question), and executive function (e.g., number counting, animal naming, picture recognition, size discrimination, and clock drawing; five questions). It contains 11 assessment items, with a total score of 0-30. A higher score indicates a higher level of cognition (Tariq, Tumosa, Chibnall, Perry III, & Morley, 2006).
Contextual Memory Test (CMT)
The CMT Memory Subscale was used to assess the memory function of MCI seniors. The CMT, a standardized memory assessment tool developed by Toglia (1993) for occupational therapists, was used to assess individual memory and meta-memory functions. This test consists of 2 cards with 20 items each related to a restaurant or breakfast (Tsai, 2006). Each card is divided into 3 dimensions: the recall subscale (40 questions), the recall awareness subscale (7 questions), and the memory strategy use subscale (6 questions). Only the recall subscale was used in this study, which included 2 dimensions: immediate recall (20 questions) and delayed recall (20 questions). Immediate recall is the ability to recall information that was accessed within 60 seconds; delayed recall is the ability to recall information that was accessed several minutes or hours ago. The total score for both immediate recall and delayed recall was 0-20, with higher scores indicating better recall ability.
Trail Making Test part-A (TMT-A)
The TMT-A, designed by Partington (1949), was used to assess the focused attention, selective attention, and executive function of MCI seniors. The participants were recorded in terms of reaction time (in seconds), starting with the number 1 and continuing sequentially until the number 25. The test was scored based on the time required to complete the connection, with lower scores indicating better ability (Tombaugh, 2004). This test has good reliability and validity (Kuo, 2018).

Secondary Outcome Measures

Instrumental activities of daily living (IADL)
The IADL was used to assess IADL function in MCI seniors. The IADL is an eight-question scale developed by Lawton, Brody, and Médecin (1969). This scale is used to assess the ability to maintain independence, which is more complex than the average individual's self-care needs. The IADL is divided into eight dimensions, including cooking, shopping, going out, housekeeping, doing laundry, making phone calls, taking medication, and managing finances. Those who check 1 or 0 are classified as disabled, with a total score of 0-8. In addition, those who need assistance with three or more of the five items (i.e., shopping, going out, cooking, housekeeping, and doing laundry) are considered mildly disabled with a score of 5 or less. The scale has good reliability and validity (Chang, Hsieh, Hsueh, & Hsieh, 2006).

Full Information

First Posted
July 4, 2021
Last Updated
July 7, 2021
Sponsor
Yang Shang-Yu
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1. Study Identification

Unique Protocol Identification Number
NCT04964011
Brief Title
Board Game Intervention to Improve Cognitive and Daily Functioning
Official Title
Board Game Intervention to Improve Cognitive and Daily Functioning in Elderly People With Mild Cognitive Impairment: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yang Shang-Yu

4. Oversight

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

5. Study Description

Brief Summary
Background: With the rapid rise of the aging population, the number of seniors with mild cognitive impairment (MCI) has increased, and without timely interventions, participants are at high risk of developing dementia. Board games have become a popular tool for cognitive training, but many board games may not be appropriate for seniors and lack the support of empirical research. Objectives: To examine the effectiveness of a 12-week board game intervention for MCI seniors in improving cognitive functioning and scores on the instrumental activities of daily living (IADL) scale. Methods: A single-blind randomized controlled trial was conducted to collect data from a long-term care facility in central Taiwan. Sixty-eight MCI seniors were recruited and randomized into a board game group (trial group) and a health promotion group (control group). Participants in both groups received a 2-hour intervention once a week for 12 weeks, with the trial group receiving 12 weeks of board games and the control group receiving 12 weeks of health promotion activities. Before and after the intervention, the primary assessment was conducted using the Saint Louis University Mental Status Exam, Contextual Memory Test, and Trail Making Test part-A; the secondary assessment was conducted using the IADL scale.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Board game group
Arm Type
Experimental
Arm Description
The Board game group was led by an occupational therapist who has been working for six years. The intervention comprised 1 week of board game instruction and 11 weeks of board game tasks (combined with daily tasks), for a total of 12 weeks, once a week for 2 hours, for a total of 24 hours of intervention.
Arm Title
Health promotion group
Arm Type
Active Comparator
Arm Description
MCI seniors in the health promotion group received general health promotion and were led by instructors from the long-term care facility for 12 weeks, including 4 weeks of physical activities, 4 weeks of singing activities, and 4 weeks of art activities, once a week for 2 hours, for a total of 24 hours.
Intervention Type
Other
Intervention Name(s)
Board game intervention
Intervention Description
In this study, the two groups, the Board game group (12-week board game intervention) and Health promotion group (12-week general health promotion intervention).
Primary Outcome Measure Information:
Title
Saint Louis University Mental Status Exam (SLUMSE)
Description
SLUMSE was used to evaluate the cognitive function of MCI seniors. SLUMSE is the most popular cognitive screening tool used worldwide to detect patients with dementia and MCI. The scale is comprised of four domains: orientation (e.g., day, year, and place; three questions), memory (e.g., remembering five things; one question), attention (e.g., story review; one question), and executive function (e.g., number counting, animal naming, picture recognition, size discrimination, and clock drawing; five questions). It contains 11 assessment items, with a total score of 0-30. A higher score indicates a higher level of cognition (Tariq, Tumosa, Chibnall, Perry III, & Morley, 2006).
Time Frame
15-25 minutes
Title
Contextual Memory Test (CMT)
Description
The CMT Memory Subscale was used to assess the memory function of MCI seniors. The CMT, a standardized memory assessment tool developed by Toglia (1993) for occupational therapists, was used to assess individual memory and meta-memory functions. This test consists of 2 cards with 20 items each related to a restaurant or breakfast (Tsai, 2006). Each card is divided into 3 dimensions: the recall subscale (40 questions), the recall awareness subscale (7 questions), and the memory strategy use subscale (6 questions). Only the recall subscale was used in this study, which included 2 dimensions: immediate recall (20 questions) and delayed recall (20 questions). Immediate recall is the ability to recall information that was accessed within 60 seconds; delayed recall is the ability to recall information that was accessed several minutes or hours ago. The total score for both immediate recall and delayed recall was 0-20, with higher scores indicating better recall ability.
Time Frame
15-20 minutes
Title
Trail Making Test part-A (TMT-A)
Description
The TMT-A, designed by Partington (1949), was used to assess the focused attention, selective attention, and executive function of MCI seniors. The participants were recorded in terms of reaction time (in seconds), starting with the number 1 and continuing sequentially until the number 25. The test was scored based on the time required to complete the connection, with lower scores indicating better ability (Tombaugh, 2004). This test has good reliability and validity (Kuo, 2018).
Time Frame
15-20 minutes
Secondary Outcome Measure Information:
Title
Instrumental activities of daily living (IADL)
Description
The IADL was used to assess IADL function in MCI seniors. The IADL is an eight-question scale developed by Lawton, Brody, and Médecin (1969). This scale is used to assess the ability to maintain independence, which is more complex than the average individual's self-care needs. The IADL is divided into eight dimensions, including cooking, shopping, going out, housekeeping, doing laundry, making phone calls, taking medication, and managing finances. Those who check 1 or 0 are classified as disabled, with a total score of 0-8. In addition, those who need assistance with three or more of the five items (i.e., shopping, going out, cooking, housekeeping, and doing laundry) are considered mildly disabled with a score of 5 or less. The scale has good reliability and validity (Chang, Hsieh, Hsueh, & Hsieh, 2006).
Time Frame
10-20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 65 years or older without a diagnosis of dementia mild neurocognitive impairment Exclusion Criteria: non-national senior citizens unable to understand the content and complete the questionnaire unable to participate in the full 12-week intervention had an acute illness such as a cold during the trial.
Facility Information:
Facility Name
Asia Univeraity
City
Taichung
State/Province
WuFeng
ZIP/Postal Code
41354
Country
Taiwan

12. IPD Sharing Statement

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Board Game Intervention to Improve Cognitive and Daily Functioning

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