Dr Solitaire: Assessing Cognitive Performance Through Meaningful Play

January 19, 2021 updated by: Universitaire Ziekenhuizen KU Leuven

Observational Study to Assess Cognitive Performance in Elderly Life Via Meaning Play

To assess cognitive performance by means of the game of Solitaire. In this study, the investigators want to define relevant game metrics, when playing Solitaire, that may be indicative of cognitive performance.

Study Overview

Status

Unknown

Conditions

Detailed Description

12-15 healthy older persons will be observed, as well as 12-15 persons with cognitive impairment, while playing Solitaire. This will take the shape of contextual inquiries, i.e. the researcher visits the older person in his/her natural context and ask his/her to play Solitaire. Older persons will be observed playing 8-10 rounds of playing Solitaire, both with a physical deck of card and on a tablet. Gameplay actions and player behaviors will be observed and recorded for later analysis, via screen capturing software installed on the tablet, including the recordings of facial expressions and verbal utterances via the integrated touchpad camera and microphone. According to the contextual inquiry method, which is a 'light' form of participant observation, the researcher will take the role of an 'apprentice'; he/she will observe and may ask questions for a better understanding of the player actions. At the end of the visit, following cognitive domains will be measured through pen-and-paper testing: visual scanning and psychomotor speed (Digit symbol substitution test), attention and executive function (Trail making test, digit span, verbal fluency, maze test), Camden topographical memory,... The duration of such a visit will last approximately 120 minutes.

These observations of game play actions and behaviors and the results that participants obtained on the cognitive test battery will be analyzed with experts in light of cognitive performance. More particular, the investigator will look for the measurable aspects of cognitive performance in the game, guided by earlier measures put forward by Jimison et al and Kaye et al. While they still list generic measures (e.g. 'target detection' or 'correctly retrieving item from previous knowledge'), this study will now operationalize these specifically for the game of Solitaire and for the target group (e.g. 'detection of card to move onto the build stack' or 'retrieving the card as available from the pile'). Hence, possible game metrics will be discussed and defined.

Study Type

Observational

Enrollment (Anticipated)

30

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

    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Hospital
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospital Leuven

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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

24-30 participants, both cognitively healthy older persons (n = 12-15) as well as older persons with mild cognitive impairment (MCI) or mild Alzheimer's disease (mAD) (12-15)

Description

Inclusion Criteria:

For the HEALTHY participants

  1. The participant has a minimum age of 65 years.
  2. The participant is living independently or semi-independently at home, service flat or care home.
  3. The participant has no subjective memory concern as reported by the participant, informant, or clinician.
  4. The participant has a normal brain function documented by scoring above 27 on the MMSE, above 26 on the MOCA and has a score of 0 for the CDR.
  5. In the opinion of the investigator, the participant is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator.
  6. The participant is fluent in written and verbal Dutch.

For the participants with COGNITIVE IMPAIRMENT:

  1. The participant has a minimum age of 65 years.
  2. The participant is living independently or semi-independently at home, service flat or care home.
  3. In the opinion of the investigator, the participant is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator.
  4. The participant is fluent in written and verbal Dutch.
  5. For MCI: MCI patients, at baseline, are diagnosed applying Petersen's diagnostic criteria, i.e., (1) cognitive complaint, preferably corroborated by an informant; (2) objective cognitive impairment, quantified as performance of more than 1.5 SD below the appropriate mean on the neuropsychological subtests (z-score below -1.5); (3) largely normal general cognitive functioning; (4) essentially intact activities of daily living (ADL) (basic and instrumental activities of daily living (iADL) were determined by a clinical interview with the patient and an informant); and (5) not demented.
  6. For AD:Probable AD according to the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Healthy Elderly
Mild Cognitive Impaired Elderly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specification of Cognitive Performance Metrics for the game Solitaire
Time Frame: 1 day
From this study, metrics will be defined which can measure cognitive performance in cardgames like Solitaire. Possible candidates are, but are not limited to: situational awareness to measure visual perception and performance on dual tasks to measure divided attention. A more detailed table of possible game metrics of cognitive performance can be found in H. B. Jimison, M. Pavel, P. Bissell, and J. McKanna, "A Framework for Cognitive Monitoring Using Computer Game Interactions," Medinfo 2007 Proc. 12th World Congr. Health Med. Inform. Build. Sustain. Health Syst., p. 1073, 2007.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Design Guidelines Apps for the Elderly
Time Frame: 1 day
While playing the Solitaire game, feedback considering the usability of the game can be used to formulate design guidelines for applications.
1 day

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Director: Vero Vanden Abeele, prof., KU Leuven
  • Principal Investigator: Karsten Gielis, Drs., KU Leuven

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.

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)

December 1, 2017

Primary Completion (Actual)

May 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • S59650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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