Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project) (GAME-Project)

Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial

Nowadays, on geriatric centres, cognitive decline used to be prevented by pen and paper exercises (Calero García & Navarro Gonzalez, 2006). However, as Lampit et al. (2014) suggest, studies based on the efficacy and effectiveness of new cognitive-based interventions in order to improve these cognitive processes are fundamental (Lampit et al., 2014). Cognitive-based interventions are interventions that directly or indirectly try to improve cognitive processes (Chiu et al., 2017). Between the different kinds of cognitive-based interventions, cognitive training permits stablish randomized controlled trials. Cognitive training consists of repeating during a concrete time a standardized set of tasks in order to maintain or improve one or some cognitive processes. Meta-analysis studies have shown that computerized cognitive training can improve in a moderate size some cognitive processes in elderly people with mild cognitive impairment or dementia (Hill et al., 2017) and without those diagnoses (Lampit, Hallock, & Valenzuela, 2014; Chiu et al., 2017). Although it seems that computerized training is effective, safe and secure, it is important to note the social component of the definition of health (OMS, 1948). Chang, Wray & Lin (2014) found that social relationships predict the use of leisure activities and this predict a better physical health and wellbeing psychological. In fact, a comparative study found that those elderly people that have played board games have a 15% lower risk of having dementia diagnose and problems related with memory (Dartigues et al., 2013). To sum up, the aim of this research project is to test the effectiveness of a cognitive training based on modern board and card games in elderly people with a diagnose of mild-cognitive impairment in comparison to do cognitive paper and pencil tasks or in a wait-list comparison group.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment, Mild
• Intervention / Treatment: Behavioral: Modern board and card games group; Behavioral: Paper and pencil tasks group

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25001
    • Recruiting
    • Faculty of Education, Psychology and Social Work; University of Lleida
    • Contact: Jorge Moya-Higueras, PhD; Phone Number: 6509 973706509; Email: jorge.moya@udl.cat
    • Principal Investigator: Jaume March-Llanes, PhD
    • Sub-Investigator: Verónica Estrada-Plana, MsC
  • Lleida, Spain, 25198
    • Recruiting
    • Cognitive disorders unity, Santa Maria's University Hospital, GSS
    • Contact: Beatriu Lara Consuegra, MsC; Phone Number: 1571 +34 972727222; Email: blara@gss.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participation in cognitive disease center
• Amnestic MCI diagnoses (clinical diagnoses following the guidelines of Petersen et al. 2011)
• Global deterioration scale (GDS) 2-3 values
• Participation assessing outcomes of the caregivers in the study

Exclusion Criteria:

• Participation in another cognitive training program
• Dementia, neurologic or other disease non-neurodegenerative, which could affect cognitive change over time (medical-reported)
• Severe visual impairment, language impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles (medical-reported)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral: modern board and card games; Participants will play modern board and card games in groups at medical center 2 times per week for at least 1 hour over a period of 16 weeks.	Behavioral: Modern board and card games group; Modern board and card games group
Active Comparator: Behavioral: paper and pencil tasks; Participants will do cognitive paper and pencil tasks in groups at medical center 2 times per week for at least 1 hour over a period of 16 weeks.	Behavioral: Paper and pencil tasks group; Paper and pencil tasks group
No Intervention: Wait-list; Participants will be in a wait-list over a period of 16 weeks. Then, they received the board and card games' or paper and pencil tasks' intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive impairment from baseline to post intervention	Addenbrooke's Cognitive Examination	Baseline and post intervention (after 16 weeks)
Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention	Copy, draw after 3 and after 25 minuts of Rey-Osterrieth Complex Figure Test	Baseline and post intervention (after 16 weeks)
Change in verbal long-term memory from baseline to post intervention	Rey Auditory Verbal Learning Test (RAVLT)	Baseline and post intervention (after 16 weeks)
Change in verbal short-term memory from baseline to post intervention	Digit Memory Test Forward	Baseline and post intervention (after 16 weeks)
Change in verbal working memory from baseline to post intervention	Digit Memory Test Backward	Baseline and post intervention (after 16 weeks)
Change in visuospatial short-term memory from baseline to post intervention	Visual Memory Test Forward	Baseline and post intervention (after 16 weeks)
Change in visuospatial working memory from baseline to post intervention	Visual Memory Test Backward	Baseline and post intervention (after 16 weeks)
Change in visuospatial processing from baseline to post intervention	Trail Making Test A and Symbol Digit Modalities Test (SDMT)	Baseline and post intervention (after 16 weeks)
Change in flexibility from baseline to post intervention	Trail Making Test B and 5 digits test	Baseline and post intervention (after 16 weeks)
Change in inhibition from baseline to post intervention	5 digits test	Baseline and post intervention (after 16 weeks)
Change in phonemic and semantic fluency from baseline to post intervention	Animals category and P, M, R letters, Spanish version	Baseline and post intervention (after 16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in neuropsychiatric symptoms from baseline to post intervention	Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology.	Baseline and post intervention (after 16 weeks)
Change in psychological well-being from baseline to post intervention	Euro Quality of Life Scale (EQ-5D), Self-reported and caregivers spanish versions. Higher scores mean higher quality of life. Visual analogue scale: minimum value=0, maximum value=100.	Baseline and post intervention (after 16 weeks)
Change in depressive symptoms from baseline to post intervention	Geriatric Depression Scale (GDS), Spanish version. Higher scores mean higher depressive symptomatology. Minimum value = 0, maximum value = 15.	Baseline and post intervention (after 16 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Status Index and sociodemographical information	Hollingshead Index, age, sex, birth location	Baseline
Cognitive reserve questionnaire	Cognitive reserve questionnaire (CRC), spanish version	Baseline
Premorbid cognitive function	The Word Accentuation Test (TAP), spanish version	Baseline

Collaborators and Investigators

• Sponsor: Brain In Game scientific-technical service
• Collaborators: University Hospital of Santa Maria, Lleida

Publications and helpful links

General Publications

• Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.
• Calero García, M. D., & Navarro Gonzalez, E. (2006). Eficacia de un programa de entrenamiento en memoria en el mantenimiento de ancianos con y sin deterioro cognitivo. Clínica y Salud, 17(2), 187-202.
• Chang PJ, Wray L, Lin Y. Social relationships, leisure activity, and health in older adults. Health Psychol. 2014 Jun;33(6):516-23. doi: 10.1037/hea0000051.
• Chiu HL, Chu H, Tsai JC, Liu D, Chen YR, Yang HL, Chou KR. The effect of cognitive-based training for the healthy older people: A meta-analysis of randomized controlled trials. PLoS One. 2017 May 1;12(5):e0176742. doi: 10.1371/journal.pone.0176742. eCollection 2017.
• 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.
• Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Memory; Cognitive training; Executive Functions; Cognitive enrichment; Modern board and card games
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NCT2021UTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No