NCT02971124

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

4.4 years

First QC Date

November 9, 2016

Last Update Submit

July 2, 2024

Conditions

Keywords

Cognitive PerformanceMeaningful PlayScreening testDementia

Outcome Measures

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.

    1 day

Secondary Outcomes (1)

  • Design Guidelines Apps for the Elderly

    1 day

Study Arms (2)

Healthy Elderly

Mild Cognitive Impaired Elderly

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Vero Vanden Abeele, prof.

    KU Leuven

    STUDY DIRECTOR
  • Karsten Gielis, Drs.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 22, 2016

Study Start

December 1, 2017

Primary Completion

May 1, 2022

Study Completion

March 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations