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

Primary Purpose

Cognitive Impairment, Mild

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Modern board and card games group
Paper and pencil tasks group
Sponsored by
Brain In Game scientific-technical service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment, Mild focused on measuring Memory, Executive Functions, Cognitive training, Cognitive enrichment, Modern board and card games

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of Education, Psychology and Social Work; University of LleidaRecruiting
  • Cognitive disorders unity, Santa Maria's University Hospital, GSSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Behavioral: modern board and card games

Behavioral: paper and pencil tasks

Wait-list

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in cognitive impairment from baseline to post intervention
Addenbrooke's Cognitive Examination
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
Change in verbal long-term memory from baseline to post intervention
Rey Auditory Verbal Learning Test (RAVLT)
Change in verbal short-term memory from baseline to post intervention
Digit Memory Test Forward
Change in verbal working memory from baseline to post intervention
Digit Memory Test Backward
Change in visuospatial short-term memory from baseline to post intervention
Visual Memory Test Forward
Change in visuospatial working memory from baseline to post intervention
Visual Memory Test Backward
Change in visuospatial processing from baseline to post intervention
Trail Making Test A and Symbol Digit Modalities Test (SDMT)
Change in flexibility from baseline to post intervention
Trail Making Test B and 5 digits test
Change in inhibition from baseline to post intervention
5 digits test
Change in phonemic and semantic fluency from baseline to post intervention
Animals category and P, M, R letters, Spanish version

Secondary Outcome Measures

Change in neuropsychiatric symptoms from baseline to post intervention
Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology.
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.
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.

Full Information

First Posted
March 22, 2021
Last Updated
April 6, 2021
Sponsor
Brain In Game scientific-technical service
Collaborators
University Hospital of Santa Maria, Lleida
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1. Study Identification

Unique Protocol Identification Number
NCT04835909
Brief Title
Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project)
Acronym
GAME-Project
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brain In Game scientific-technical service
Collaborators
University Hospital of Santa Maria, Lleida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Mild
Keywords
Memory, Executive Functions, Cognitive training, Cognitive enrichment, Modern board and card games

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral: modern board and card games
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral: paper and pencil tasks
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modern board and card games group
Intervention Description
Modern board and card games group
Intervention Type
Behavioral
Intervention Name(s)
Paper and pencil tasks group
Intervention Description
Paper and pencil tasks group
Primary Outcome Measure Information:
Title
Change in cognitive impairment from baseline to post intervention
Description
Addenbrooke's Cognitive Examination
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in visuoconstruction, immediate memory and long-term memory from baseline to post intervention
Description
Copy, draw after 3 and after 25 minuts of Rey-Osterrieth Complex Figure Test
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in verbal long-term memory from baseline to post intervention
Description
Rey Auditory Verbal Learning Test (RAVLT)
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in verbal short-term memory from baseline to post intervention
Description
Digit Memory Test Forward
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in verbal working memory from baseline to post intervention
Description
Digit Memory Test Backward
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in visuospatial short-term memory from baseline to post intervention
Description
Visual Memory Test Forward
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in visuospatial working memory from baseline to post intervention
Description
Visual Memory Test Backward
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in visuospatial processing from baseline to post intervention
Description
Trail Making Test A and Symbol Digit Modalities Test (SDMT)
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in flexibility from baseline to post intervention
Description
Trail Making Test B and 5 digits test
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in inhibition from baseline to post intervention
Description
5 digits test
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in phonemic and semantic fluency from baseline to post intervention
Description
Animals category and P, M, R letters, Spanish version
Time Frame
Baseline and post intervention (after 16 weeks)
Secondary Outcome Measure Information:
Title
Change in neuropsychiatric symptoms from baseline to post intervention
Description
Neuropsychiatric Inventory (NPI), Self-reported and caregivers spanish versions. Higher scores mean higher neuropsychiatric symptomatology.
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in psychological well-being from baseline to post intervention
Description
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.
Time Frame
Baseline and post intervention (after 16 weeks)
Title
Change in depressive symptoms from baseline to post intervention
Description
Geriatric Depression Scale (GDS), Spanish version. Higher scores mean higher depressive symptomatology. Minimum value = 0, maximum value = 15.
Time Frame
Baseline and post intervention (after 16 weeks)
Other Pre-specified Outcome Measures:
Title
Social Status Index and sociodemographical information
Description
Hollingshead Index, age, sex, birth location
Time Frame
Baseline
Title
Cognitive reserve questionnaire
Description
Cognitive reserve questionnaire (CRC), spanish version
Time Frame
Baseline
Title
Premorbid cognitive function
Description
The Word Accentuation Test (TAP), spanish version
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Faculty of Education, Psychology and Social Work; University of Lleida
City
Lleida
ZIP/Postal Code
25001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Moya-Higueras, PhD
Phone
973706509
Ext
6509
Email
jorge.moya@udl.cat
First Name & Middle Initial & Last Name & Degree
Jaume March-Llanes, PhD
First Name & Middle Initial & Last Name & Degree
Verónica Estrada-Plana, MsC
Facility Name
Cognitive disorders unity, Santa Maria's University Hospital, GSS
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriu Lara Consuegra, MsC
Phone
+34 972727222
Ext
1571
Email
blara@gss.cat

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
24884905
Citation
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.
Results Reference
background
PubMed Identifier
28459873
Citation
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.
Results Reference
background
PubMed Identifier
23988362
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.
Results Reference
background
PubMed Identifier
27838936
Citation
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.
Results Reference
background
PubMed Identifier
25405755
Citation
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.
Results Reference
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Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project)

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