Clinical trial NCT02971124: Dr Solitaire: Assessing Cognitive Performance Through Meaningful Play
Official title: Observational Study to Assess Cognitive Performance in Elderly Life Via Meaning Play
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: eHealth
Keywords: Cognitive Performance
Meaningful Play
Screening test
Dementia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2016-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

Brief 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Specification of Cognitive Performance Metrics for the game Solitaire
timeFrame: 1 day
Secondary outcomes:
measure: Design Guidelines Apps for the Elderly
timeFrame: 1 day
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Vero Vanden Abeele, prof.
role: STUDY_DIRECTOR
affiliation: KU Leuven
name: Karsten Gielis, Drs.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.