Mild Cognitive ImpairmentNCT04964011
Board Game Intervention to Improve Cognitive and Daily Functioning
A study testing Board game intervention in people with Mild Cognitive Impairment, run by Yang Shang-Yu at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Board game intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 88 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 years or older without a diagnosis of dementia
- mild neurocognitive impairment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Board Game Intervention to Improve Cognitive and Daily Functioning in Elderly People With Mild Cognitive Impairment: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Board game intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Board game interventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Board game intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 15-20 minutes
Secondary outcomes (1)
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).
Measured: 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start3 Jan 2020
- Primary completion22 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Shang-Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Shang-Yu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964011
- Sponsor's protocol ID
- CRREC-108-141
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Board Game Intervention to Improve Cognitive and Daily Functioning in Elderly People With Mild Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04964011
- Acronym / sponsor ID
- CRREC-108-141
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yang Shang-YuUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Board game group | Experimental | Other: Board game interventionThe 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. |
| Health promotion group | Active comparator | Other: Board game interventionMCI 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. |
Who may qualify
- Ages
- 65 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged 65 years or older without a diagnosis of dementia
- mild neurocognitive impairment
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Board game interventionIn this study, the two groups, the Board game group (12-week board game intervention) and Health promotion group (12-week general health promotion intervention). | Other | Board game group, Health promotion group |
Primary outcome
Saint Louis University Mental Status Exam (SLUMSE)
Time frame: 15-25 minutes
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)
Time frame: 15-20 minutes
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)
Time frame: 15-20 minutes
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).
1 secondary outcome
Instrumental activities of daily living (IADL)
Time frame: 10-20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Board game intervention in people with Mild Cognitive Impairment, run by Yang Shang-Yu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saint Louis University Mental Status Exam (SLUMSE) (time frame: 15-25 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.