NCT06306365

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

October 4, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

February 22, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

Modern board gameExecutive functionsSocial participationWell-beingOlder people

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

Subjects belonging to this group perform a modern board game-based learning.

Behavioral: Modern board game-based learning

Control (no intervention)

NO INTERVENTION

Subjects belonging to this group not perform intervention.

Interventions

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.

Experimental

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be residents of the Centro Doctor Villacián (Valladolid).
  • Willing to commit to the study.
  • Have literacy skills.

You may not qualify if:

  • · Presentation of advanced dementia case.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University Miguel of Cervante

Valladolid, 47012, Spain

Location

Related 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.

    PMID: 31432758BACKGROUND
  • 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.

    PMID: 12815136BACKGROUND
  • 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.

    PMID: 33275804BACKGROUND
  • 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.

    PMID: 23988362BACKGROUND
  • 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.

    PMID: 30864747BACKGROUND
  • 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.

    PMID: 33138738BACKGROUND
  • 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.

    PMID: 30820242BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 12, 2024

Study Start

February 7, 2024

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

October 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations