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Cognitive Impairment, MildGAME-ProjectNCT04835909

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

A study testing Modern board and card games group and Paper and pencil tasks group in people with Cognitive Impairment, Mild, run by Brain In Game scientific-technical service at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Cognitive Impairment, Mild
What is being tested?
Modern board and card games group and Paper and pencil tasks group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
2 sitesSpain
Study dates
16 Feb 2021to Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Spain2 sites, 2 recruiting

  • Faculty of Education, Psychology and Social Work; University of Lleida

    Lleida, 25001

    Jorge Moya-Higueras, PhD, 973706509 ext. 6509, jorge.moya@udl.cat

    Jaume March-Llanes, PhD

    Recruiting

  • Cognitive disorders unity, Santa Maria's University Hospital, GSS

    Lleida, 25198

    Beatriu Lara Consuegra, MsC, +34 972727222 ext. 1571, blara@gss.cat

    Recruiting

Other trials in Spain

About this study

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

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.

Being tested
Modern board and card games group, Paper and pencil tasks group
Keywords
Memory, Executive Functions, Cognitive training, Cognitive enrichment, Modern board and card games
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modern board and card games groupBehavioural

    Modern board and card games group

  • Paper and pencil tasks groupBehavioural

    Paper and pencil tasks group

Study groups in NCT04835909
Study groupRoleWhat they receive
Behavioral: modern board and card gamesExperimentalParticipants 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.
Receives: Behavioral: Modern board and card games group
Behavioral: paper and pencil tasksActive comparatorParticipants 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.
Receives: Behavioral: Paper and pencil tasks group
Wait-listNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognitive impairment from baseline to post intervention

    Addenbrooke's Cognitive Examination

    Measured: Baseline and post intervention (after 16 weeks)

  2. 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

    Measured: Baseline and post intervention (after 16 weeks)

  3. Change in verbal long-term memory from baseline to post intervention

    Rey Auditory Verbal Learning Test (RAVLT)

    Measured: Baseline and post intervention (after 16 weeks)

  4. Change in verbal short-term memory from baseline to post intervention

    Digit Memory Test Forward

    Measured: Baseline and post intervention (after 16 weeks)

  5. Change in verbal working memory from baseline to post intervention

    Digit Memory Test Backward

    Measured: Baseline and post intervention (after 16 weeks)

  6. Change in visuospatial short-term memory from baseline to post intervention

    Visual Memory Test Forward

    Measured: Baseline and post intervention (after 16 weeks)

  7. Change in visuospatial working memory from baseline to post intervention

    Visual Memory Test Backward

    Measured: Baseline and post intervention (after 16 weeks)

  8. Change in visuospatial processing from baseline to post intervention

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

    Measured: Baseline and post intervention (after 16 weeks)

  9. Change in flexibility from baseline to post intervention

    Trail Making Test B and 5 digits test

    Measured: Baseline and post intervention (after 16 weeks)

  10. Change in inhibition from baseline to post intervention

    5 digits test

    Measured: Baseline and post intervention (after 16 weeks)

  11. Change in phonemic and semantic fluency from baseline to post intervention

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

    Measured: Baseline and post intervention (after 16 weeks)

Secondary outcomes (3)

  1. Change in neuropsychiatric symptoms from baseline to post intervention

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

    Measured: Baseline and post intervention (after 16 weeks)

  2. 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.

    Measured: Baseline and post intervention (after 16 weeks)

  3. 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.

    Measured: Baseline and post intervention (after 16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start16 Feb 2021
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835909
Sponsor's protocol ID
NCT2021UTC
Acronym
GAME-Project
Status last verified
Apr 2021
First submitted
22 Mar 2021
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24884905

  • 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.

    PubMed 28459873

  • 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.

    PubMed 23988362

  • 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.

    PubMed 27838936

  • 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.

    PubMed 25405755

Questions about this trial

What is this clinical trial studying?

A study testing Modern board and card games group and Paper and pencil tasks group in people with Cognitive Impairment, Mild, run by Brain In Game scientific-technical service at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive impairment from baseline to post intervention (time frame: Baseline and post intervention (after 16 weeks)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835909, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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