eHealthNCT02971124
Dr Solitaire: Assessing Cognitive Performance Through Meaningful Play
An observational study of eHealth, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- eHealth
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Dec 2017to 1 Mar 2025
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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)
Who may be able to join
- For the HEALTHY participants
- The participant has a minimum age of 65 years.
- The participant is living independently or semi-independently at home, service flat or care home.
- The participant has no subjective memory concern as reported by the participant, informant, or clinician.
- 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.
- 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.
Show all 14Show fewer
- The participant is fluent in written and verbal Dutch.
- For the participants with COGNITIVE IMPAIRMENT:
- The participant has a minimum age of 65 years.
- The participant is living independently or semi-independently at home, service flat or care home.
- 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.
- The participant is fluent in written and verbal Dutch.
- 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.
- For AD:Probable AD according to the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Jessa Hospital
Hasselt, Limburg, 3500
University Hospital Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: 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.
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.
- Conditions
- eHealth
- Keywords
- Cognitive Performance, Meaningful Play, Screening test, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Elderly | Not described | |
| Mild Cognitive Impaired Elderly | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start1 Dec 2017
- Primary completion1 May 2022
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for eHealthStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Vero Vanden Abeele, prof., Study director, KU LeuvenKarsten Gielis, Drs., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971124
- Sponsor's protocol ID
- S59650
- Status last verified
- Jul 2024
- First submitted
- 9 Nov 2016
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess Cognitive Performance in Elderly Life Via Meaning Play
- ClinicalTrials.gov ID
- NCT02971124
- Acronym / sponsor ID
- S59650
- Conditions
- eHealth
- Keywords
- Cognitive Performance, Meaningful Play, Screening test, Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Elderly | – | – |
| Mild Cognitive Impaired Elderly | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (14 listed)
- For the HEALTHY participants
- The participant has a minimum age of 65 years.
- The participant is living independently or semi-independently at home, service flat or care home.
- The participant has no subjective memory concern as reported by the participant, informant, or clinician.
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Design Guidelines Apps for the Elderly
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 34734825Gielis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vero Vanden Abeele, prof. study director
KU Leuven
Karsten Gielis, Drs. principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of eHealth, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 14 inclusion and 1 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 3 Jul 2024. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specification of Cognitive Performance Metrics for the game Solitaire (time frame: 1 day). 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 NCT02971124, which also lists 1 linked publication.
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 3 Jul 2024.