NCT04964011

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

19 days

First QC Date

July 4, 2021

Last Update Submit

July 7, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    15-25 minutes

  • 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.

    15-20 minutes

  • 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).

    15-20 minutes

Secondary Outcomes (1)

  • Instrumental activities of daily living (IADL)

    10-20 minutes

Study Arms (2)

Board game group

EXPERIMENTAL

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.

Other: Board game intervention

Health promotion group

ACTIVE COMPARATOR

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.

Other: Board game intervention

Interventions

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).

Board game groupHealth promotion group

Eligibility Criteria

Age65 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia Univeraity

Taichung, WuFeng, 41354, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 15, 2021

Study Start

January 3, 2020

Primary Completion

January 22, 2020

Study Completion

June 30, 2020

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations