- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06306365
Effects of Modern Board Games on Well Being in Older Adults (JUMEMO3e+)
Intervention Program on Executive Functions, Participation and Well-being in Older Adults Using Modern Board Games.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Valladolid, Spain, 47012
- European University Miguel of Cervante
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Be residents of the Centro Doctor Villacián (Valladolid).
- Willing to commit to the study.
- Have literacy skills.
Exclusion criteria:
· Presentation of advanced dementia case.
Study Plan
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 |
|---|---|
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Experimental: Experimental
Subjects belonging to this group perform a modern board game-based learning.
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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.
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No Intervention: Control (no intervention)
Subjects belonging to this group not perform intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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0 weeks,12 weeks
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Trail Making Test to evaluate Executive Functions
Time Frame: 0 weeks,12 weeks
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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. |
0 weeks,12 weeks
|
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Assessment of quality of life in older adults and people with disabilities
Time Frame: 0 weeks,12 weeks
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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).
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0 weeks,12 weeks
|
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Psychometric development and practical use
Time Frame: 0 weeks,12 weeks
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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).
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0 weeks,12 weeks
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Dartigues 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.
- Verghese 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.
- Estrada-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.
- 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.
- Gates 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.
- Lee 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.
- Nakao 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.
Helpful Links
- 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.
- Envejecimiento activo: un cambio de paradigma sobre el envejecimiento y la vejez. Aula abierta, 47(1), 45-54.
- Related Info
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PI-DOC003-WBOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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