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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06306365
Other study ID # PI-DOC003-WBOA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2024
Est. completion date June 28, 2024

Study information

Verified date March 2024
Source European University Miguel de Cervantes
Contact Azael J. Herrero, PhD
Phone +34983001000
Email jaherrero@uemc.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date June 28, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 120 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Modern board game-based learning
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.

Locations

Country Name City State
Spain European University Miguel of Cervante Valladolid

Sponsors (2)

Lead Sponsor Collaborator
European University Miguel de Cervantes Centro Doctor Villacián, Valladolid, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 0 weeks,12 weeks
Primary 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.
0 weeks,12 weeks
Primary 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). 0 weeks,12 weeks
Primary 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). 0 weeks,12 weeks
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