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

April 6, 2021 updated by: jaume march llanes, Brain In Game scientific-technical service

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25001
        • Recruiting
        • Faculty of Education, Psychology and Social Work; University of Lleida
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cognitive impairment from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
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
Time Frame: Baseline and post intervention (after 16 weeks)
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
Time Frame: Baseline and post intervention (after 16 weeks)
Rey Auditory Verbal Learning Test (RAVLT)
Baseline and post intervention (after 16 weeks)
Change in verbal short-term memory from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
Digit Memory Test Forward
Baseline and post intervention (after 16 weeks)
Change in verbal working memory from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
Digit Memory Test Backward
Baseline and post intervention (after 16 weeks)
Change in visuospatial short-term memory from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
Visual Memory Test Forward
Baseline and post intervention (after 16 weeks)
Change in visuospatial working memory from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
Visual Memory Test Backward
Baseline and post intervention (after 16 weeks)
Change in visuospatial processing from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
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
Time Frame: Baseline and post intervention (after 16 weeks)
Trail Making Test B and 5 digits test
Baseline and post intervention (after 16 weeks)
Change in inhibition from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
5 digits test
Baseline and post intervention (after 16 weeks)
Change in phonemic and semantic fluency from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
Animals category and P, M, R letters, Spanish version
Baseline and post intervention (after 16 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in neuropsychiatric symptoms from baseline to post intervention
Time Frame: Baseline and post intervention (after 16 weeks)
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
Time Frame: 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.
Baseline and post intervention (after 16 weeks)
Change in depressive symptoms from baseline to post intervention
Time Frame: 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.
Baseline and post intervention (after 16 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social Status Index and sociodemographical information
Time Frame: Baseline
Hollingshead Index, age, sex, birth location
Baseline
Cognitive reserve questionnaire
Time Frame: Baseline
Cognitive reserve questionnaire (CRC), spanish version
Baseline
Premorbid cognitive function
Time Frame: Baseline
The Word Accentuation Test (TAP), spanish version
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brain In Game scientific-technical service

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital of Santa Maria, Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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