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Active, not recruitingNCT02971124Updated Jul 3, 2024

Dr Solitaire: Assessing Cognitive Performance Through Meaningful Play

An observational study in eHealth, sponsored by Universitaire Ziekenhuizen KU Leuven. Active, not recruiting at 2 sites in Belgium. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • eHealth

Keywords

  • Cognitive Performance
  • Meaningful Play
  • Screening test
  • Dementia
03

In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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)

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

Exclusion Criteria:

-

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy Elderly
  • Mild Cognitive Impaired Elderly
06

What researchers measure

Primary outcomes

  1. Specification of Cognitive Performance Metrics for the game Solitaire

    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.

    Time frame: 1 day

Secondary outcomes

  1. Design Guidelines Apps for the Elderly

    While playing the Solitaire game, feedback considering the usability of the game can be used to formulate design guidelines for applications.

    Time frame: 1 day

07

Study locations

2 sites
  • Jessa Hospital
    Hasselt, Limburg 3500, Belgium
  • University Hospital Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
08

References and documents

Publications

  • Gielis K, Vanden Abeele ME, De Croon R, Dierick P, Ferreira-Brito F, Van Assche L, Verbert K, Tournoy J, Vanden Abeele V. Dissecting Digital Card Games to Yield Digital Biomarkers for the Assessment of Mild Cognitive Impairment: Methodological Approach and Exploratory Study. JMIR Serious Games. 2021 Nov 4;9(4):e18359. doi: 10.2196/18359. PubMed 34734825 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02971124
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
Responsible party
Sponsor
First posted
Nov 22, 2016
Start date
Dec 1, 2017
Primary completion
May 1, 2022
Completion
Mar 1, 2025 (estimated)
Last update
Jul 3, 2024

Study contacts

Vero Vanden Abeele, prof.
study director · KU Leuven
Karsten Gielis, Drs.
principal investigator · KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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