Executive FunctionsJUMEMO3e+NCT06306365
Effects of Modern Board Games on Well Being in Older Adults
A study testing Modern board game-based learning in people with Executive Functions, run by European University Miguel de Cervantes at 1 site in Spain.
Trial summary
The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Functions
- What is being tested?
- Modern board game-based learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2024to 28 Jun 2024
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be residents of the Centro Doctor Villacián (Valladolid).
- Willing to commit to the study.
- Have literacy skills.
Who cannot join
- Presentation of advanced dementia case.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Program on Executive Functions, Participation and Well-being in Older Adults Using Modern Board Games.
The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.
Read the detailed description
The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The intervention will last for 12 weeks, incorporating the use of the 16 board games identified in the previous study, which also established the most suitable adaptations and methodologies for this age group. The study will take place in a senior living facility. A quasi-experimental methodology will be employed, involving both a control group and an experimental group. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.
- Conditions
- Executive Functions
- Being tested
- Modern board game-based learning
- Keywords
- Modern board game, Executive functions, Social participation, Well-being, Older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern board game-based learningBehavioural
Modern board game-based learning involves using contemporary board games as educational tools. It emphasizes active participation, critical thinking, and social interaction among participants. By integrating strategic thinking and problem-solving within a game context, this approach aims to enhance learning experiences in an engaging and enjoyable manner. In this study, board games have been selected to target and engage executive functions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects belonging to this group perform a modern board game-based learning. Receives: Behavioral: Modern board game-based learning |
| Control (no intervention) | No intervention | Subjects belonging to this group not perform intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination for Mental Disorders of the Elderly
The cognitive subscale "CAMCONG" is used, Section B of the CAMDEX-R (Cambridge Examination for Mental Disorders of the Elderly, adapted to Spanish by López-Pousa (2015)). It consists of 60 items (neuropsychological areas). The maximum score is 105 points in this revised option. In the scale validated by López-Pousa and others (1990), the cutoff point that best discriminated between a subject with dementia and one without dementia was 69/70. The scores for the different cognitive functions: orientation (minimun score 0, máximum score 10), language (minimun score 0, maximum score 30), memory (minimum score 0, maximum score 27), attention/calculation (minimum score 0, maximum score 9), praxis (minimun score 0, máximum score 12), abstract thinking (minimum score 0, maximum score 8), perception (mínimum score 0, máximum score 9). Minimum score: 0, total maximum score: 105. Executive function (maximum score is 28). A higher score indicates a better state of executive functions.
Measured: 0 weeks,12 weeks
Trail Making Test to evaluate Executive Functions
As a complement to assess executive functions, the TESEN (Trail Making Test to evaluate Executive Functions) is used, by Portellano Pérez and Martínez Arias (2014). It consists of four subtests (trails) where the evaluated person initiates increasingly complex cognitive processes and demands that measure functions such as working memory, prospective memory, motor processing speed, perceptual speed, inhibition, sustained attention, and alternating attention.
The TESEN provides three different scores for each trail, which are: execution score (E=hits-errors/time), speed score (V=time in seconds), and accuracy score (P=hits-errors/hits). In the quick correction mode, these values can be converted into decatips, a scale from 1 to 10, where the highest level indicates better development of executive functions.
Measured: 0 weeks,12 weeks
Assessment of quality of life in older adults and people with disabilities
The FUMAT scale (Gómez, Verdugo, Arias, and Navas, 2008) is an assessment instrument composed of 8 subscales that make up Quality of Life. In this study, the dimensions corresponding to will be used: emotional well-being (8 items, minimun score 8, maximum score 32); interpersonal relationships (6 items, minimun score 6, maximum score 24); personal development (8 items, minimum score 8, maximum score 32); social inclusión (9 items, minimun score 9, maximum score 36).
Measured: 0 weeks,12 weeks
Psychometric development and practical use
The Volitional Questionnaire (VQ) by De las Heras, Geist, and Kielhofner (1998) consists of 14 items with a four-level scale, covering the continuum from spontaneous (highest level) to passive (lowest level). The total score of the questionnaire is 56 points and is divided into three scales (exploration, competence, and achievement). A higher score indicates higher levels of volition. Below is indicated the subscale, the number of ítems, the mínimum score and the máximum sore: exploration (5 items, mínimum score 5, maximum score 20), competence (5 items, mínimum score 5, maximum score 20), achievement (4 items, mínimum score 4, maximum score 15).
Measured: 0 weeks,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start7 Feb 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Executive FunctionsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Doctor Villacián, Valladolid, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306365
- Sponsor's protocol ID
- PI-DOC003-WBOA
- Acronym
- JUMEMO3e+
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ching-Teng Y. Effect of board game activities on cognitive function improvement among older adults in adult day care centers. Soc Work Health Care. 2019 Oct;58(9):825-838. doi: 10.1080/00981389.2019.1656143. Epub 2019 Aug 21.
PubMed 31432758Verghese J, Lipton RB, Katz MJ, Hall CB, Derby CA, Kuslansky G, Ambrose AF, Sliwinski M, Buschke H. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003 Jun 19;348(25):2508-16. doi: 10.1056/NEJMoa022252.
PubMed 12815136Estrada-Plana V, Montanera R, Ibarz-Estruga A, March-Llanes J, Vita-Barrull N, Guzman N, Ros-Morente A, Ayesa Arriola R, Moya-Higueras J. Cognitive training with modern board and card games in healthy older adults: two randomized controlled trials. Int J Geriatr Psychiatry. 2021 Jun;36(6):839-850. doi: 10.1002/gps.5484. Epub 2021 Jan 8.
PubMed 33275804Dartigues JF, Foubert-Samier A, Le Goff M, Viltard M, Amieva H, Orgogozo JM, Barberger-Gateau P, Helmer C. Playing board games, cognitive decline and dementia: a French population-based cohort study. BMJ Open. 2013 Aug 29;3(8):e002998. doi: 10.1136/bmjopen-2013-002998.
PubMed 23988362Gates NJ, Vernooij RW, Di Nisio M, Karim S, March E, Martinez G, Rutjes AW. Computerised cognitive training for preventing dementia in people with mild cognitive impairment. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD012279. doi: 10.1002/14651858.CD012279.pub2.
PubMed 30864747Lee BO, Yao CT, Pan CF. Effectiveness of board game activities for reducing depression among older adults in adult day care centers of Taiwan: a quasi-experimental study. Soc Work Health Care. 2020 Oct-Dec;59(9-10):725-737. doi: 10.1080/00981389.2020.1842576. Epub 2020 Nov 2.
PubMed 33138738Nakao M. Special series on "effects of board games on health education and promotion" board games as a promising tool for health promotion: a review of recent literature. Biopsychosoc Med. 2019 Feb 19;13:5. doi: 10.1186/s13030-019-0146-3. eCollection 2019.
PubMed 30820242
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Program on Executive Functions, Participation and Well-being in Older Adults Using Modern Board Games.
- ClinicalTrials.gov ID
- NCT06306365
- Acronym / sponsor ID
- JUMEMO3e+ / PI-DOC003-WBOA
- Conditions
- Executive Functions
- Keywords
- Modern board game, Executive functions, Social participation, Well-being, Older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Collaborators
- Centro Doctor Villacián, Valladolid, Spain
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 12 Mar 2024 (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.
The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.
Detailed description
The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The intervention will last for 12 weeks, incorporating the use of the 16 board games identified in the previous study, which also established the most suitable adaptations and methodologies for this age group. The study will take place in a senior living facility. A quasi-experimental methodology will be employed, involving both a control group and an experimental group. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Modern board game-based learningSubjects belonging to this group perform a modern board game-based learning. |
| Control (no intervention) | No intervention | –Subjects belonging to this group not perform intervention. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Be residents of the Centro Doctor Villacián (Valladolid).
- Willing to commit to the study.
- Have literacy skills.
Key exclusion criteria (1 listed)
- Presentation of advanced dementia case.
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 |
|---|---|---|
| Modern board game-based learningModern board game-based learning involves using contemporary board games as educational tools. It emphasizes active participation, critical thinking, and social interaction among participants. By integrating strategic thinking and problem-solving within a game context, this approach aims to enhance learning experiences in an engaging and enjoyable manner. In this study, board games have been selected to target and engage executive functions. | Behavioural | Experimental |
Primary outcome
Examination for Mental Disorders of the Elderly
Time frame: 0 weeks,12 weeks
The cognitive subscale "CAMCONG" is used, Section B of the CAMDEX-R (Cambridge Examination for Mental Disorders of the Elderly, adapted to Spanish by López-Pousa (2015)). It consists of 60 items (neuropsychological areas). The maximum score is 105 points in this revised option. In the scale validated by López-Pousa and others (1990), the cutoff point that best discriminated between a subject with dementia and one without dementia was 69/70. The scores for the different cognitive functions: orientation (minimun score 0, máximum score 10), language (minimun score 0, maximum score 30), memory (minimum score 0, maximum score 27), attention/calculation (minimum score 0, maximum score 9), praxis (minimun score 0, máximum score 12), abstract thinking (minimum score 0, maximum score 8), perception (mínimum score 0, máximum score 9). Minimum score: 0, total maximum score: 105. Executive function (maximum score is 28). A higher score indicates a better state of executive functions.
Trail Making Test to evaluate Executive Functions
Time frame: 0 weeks,12 weeks
As a complement to assess executive functions, the TESEN (Trail Making Test to evaluate Executive Functions) is used, by Portellano Pérez and Martínez Arias (2014). It consists of four subtests (trails) where the evaluated person initiates increasingly complex cognitive processes and demands that measure functions such as working memory, prospective memory, motor processing speed, perceptual speed, inhibition, sustained attention, and alternating attention. The TESEN provides three different scores for each trail, which are: execution score (E=hits-errors/time), speed score (V=time in seconds), and accuracy score (P=hits-errors/hits). In the quick correction mode, these values can be converted into decatips, a scale from 1 to 10, where the highest level indicates better development of executive functions.
Assessment of quality of life in older adults and people with disabilities
Time frame: 0 weeks,12 weeks
The FUMAT scale (Gómez, Verdugo, Arias, and Navas, 2008) is an assessment instrument composed of 8 subscales that make up Quality of Life. In this study, the dimensions corresponding to will be used: emotional well-being (8 items, minimun score 8, maximum score 32); interpersonal relationships (6 items, minimun score 6, maximum score 24); personal development (8 items, minimum score 8, maximum score 32); social inclusión (9 items, minimun score 9, maximum score 36).
Psychometric development and practical use
Time frame: 0 weeks,12 weeks
The Volitional Questionnaire (VQ) by De las Heras, Geist, and Kielhofner (1998) consists of 14 items with a four-level scale, covering the continuum from spontaneous (highest level) to passive (lowest level). The total score of the questionnaire is 56 points and is divided into three scales (exploration, competence, and achievement). A higher score indicates higher levels of volition. Below is indicated the subscale, the number of ítems, the mínimum score and the máximum sore: exploration (5 items, mínimum score 5, maximum score 20), competence (5 items, mínimum score 5, maximum score 20), achievement (4 items, mínimum score 4, maximum score 15).
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 4 Oct 2024.
- Background: PubMed 31432758Ching-Teng Y. Effect of board game activities on cognitive function improvement among older adults in adult day care centers. Soc Work Health Care. 2019 Oct;58(9):825-838. doi: 10.1080/00981389.2019.1656143. Epub 2019 Aug 21.
- Background: PubMed 12815136Verghese J, Lipton RB, Katz MJ, Hall CB, Derby CA, Kuslansky G, Ambrose AF, Sliwinski M, Buschke H. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003 Jun 19;348(25):2508-16. doi: 10.1056/NEJMoa022252.
- Background: PubMed 33275804Estrada-Plana V, Montanera R, Ibarz-Estruga A, March-Llanes J, Vita-Barrull N, Guzman N, Ros-Morente A, Ayesa Arriola R, Moya-Higueras J. Cognitive training with modern board and card games in healthy older adults: two randomized controlled trials. Int J Geriatr Psychiatry. 2021 Jun;36(6):839-850. doi: 10.1002/gps.5484. Epub 2021 Jan 8.
- Background: PubMed 23988362Dartigues JF, Foubert-Samier A, Le Goff M, Viltard M, Amieva H, Orgogozo JM, Barberger-Gateau P, Helmer C. Playing board games, cognitive decline and dementia: a French population-based cohort study. BMJ Open. 2013 Aug 29;3(8):e002998. doi: 10.1136/bmjopen-2013-002998.
- Background: PubMed 30864747Gates NJ, Vernooij RW, Di Nisio M, Karim S, March E, Martinez G, Rutjes AW. Computerised cognitive training for preventing dementia in people with mild cognitive impairment. Cochrane Database Syst Rev. 2019 Mar 13;3(3):CD012279. doi: 10.1002/14651858.CD012279.pub2.
- Background: PubMed 33138738Lee BO, Yao CT, Pan CF. Effectiveness of board game activities for reducing depression among older adults in adult day care centers of Taiwan: a quasi-experimental study. Soc Work Health Care. 2020 Oct-Dec;59(9-10):725-737. doi: 10.1080/00981389.2020.1842576. Epub 2020 Nov 2.
- Background: PubMed 30820242Nakao M. Special series on "effects of board games on health education and promotion" board games as a promising tool for health promotion: a review of recent literature. Biopsychosoc Med. 2019 Feb 19;13:5. doi: 10.1186/s13030-019-0146-3. eCollection 2019.
- Developing serious games to promote cognitive abilities for the elderly. In 2017 IEEE 5th International Conference on Serious Games and Applications for Health (SeGAH) (pp. 1-8). IEEE.Link provided by the sponsor.
- Envejecimiento activo: un cambio de paradigma sobre el envejecimiento y la vejez. Aula abierta, 47(1), 45-54.Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Modern board game-based learning in people with Executive Functions, run by European University Miguel de Cervantes at 1 site in Spain.
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 3 inclusion and 1 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 4 Oct 2024. 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 Spain. 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?
Examination for Mental Disorders of the Elderly (time frame: 0 weeks,12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306365, which also lists 7 linked publications.
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 4 Oct 2024.