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

Sponsor
Brain In Game scientific-technical service (Other)
Overall Status
Recruiting
CT.gov ID
NCT04835909
Collaborator
University Hospital of Santa Maria, Lleida (Other)
112
2
3
36.4
56
1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Modern board and card games group
  • Behavioral: Paper and pencil tasks group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial
Actual Study Start Date :
Feb 16, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in cognitive impairment from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Addenbrooke's Cognitive Examination

  2. Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Copy, draw after 3 and after 25 minuts of Rey-Osterrieth Complex Figure Test

  3. Change in verbal long-term memory from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Rey Auditory Verbal Learning Test (RAVLT)

  4. Change in verbal short-term memory from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Digit Memory Test Forward

  5. Change in verbal working memory from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Digit Memory Test Backward

  6. Change in visuospatial short-term memory from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Visual Memory Test Forward

  7. Change in visuospatial working memory from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Visual Memory Test Backward

  8. Change in visuospatial processing from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Trail Making Test A and Symbol Digit Modalities Test (SDMT)

  9. Change in flexibility from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Trail Making Test B and 5 digits test

  10. Change in inhibition from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    5 digits test

  11. Change in phonemic and semantic fluency from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Animals category and P, M, R letters, Spanish version

Secondary Outcome Measures

  1. Change in neuropsychiatric symptoms from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology.

  2. Change in psychological well-being from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    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.

  3. Change in depressive symptoms from baseline to post intervention [Baseline and post intervention (after 16 weeks)]

    Geriatric Depression Scale (GDS), Spanish version. Higher scores mean higher depressive symptomatology. Minimum value = 0, maximum value = 15.

Other Outcome Measures

  1. Social Status Index and sociodemographical information [Baseline]

    Hollingshead Index, age, sex, birth location

  2. Cognitive reserve questionnaire [Baseline]

    Cognitive reserve questionnaire (CRC), spanish version

  3. Premorbid cognitive function [Baseline]

    The Word Accentuation Test (TAP), spanish version

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participation in cognitive disease center

  • Amnestic MCI diagnoses (clinical diagnoses following the guidelines of Petersen et al.

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Education, Psychology and Social Work; University of Lleida Lleida Spain 25001
2 Cognitive disorders unity, Santa Maria's University Hospital, GSS Lleida Spain 25198

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
jaume march llanes, Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial, Brain In Game scientific-technical service
ClinicalTrials.gov Identifier:
NCT04835909
Other Study ID Numbers:
  • NCT2021UTC
First Posted:
Apr 8, 2021
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by jaume march llanes, Effectiveness on Cognition of a Cognitive Training Intervention Based on Modern Board and Card Games in Mild Cognitive Impairment Patients: a Randomized Controlled Trial, Brain In Game scientific-technical service
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021