NCT05784623

Brief Summary

The main objective is to assess the usability of a novel tool of neurocognitive disorders detection, called the Digitracking, by the elderly population. The Digitracking technique is based on the eye tracking concept to assess cognitive decline (Lio et al. 2019). Instead of capturing eye movements, the new device captures the finger trajectory while exploring a blurred picture on a tablet. The usability of such a technology is assessed through objective and subjective metrics, such as the user experience.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

March 1, 2023

Last Update Submit

March 13, 2023

Conditions

Keywords

digit-trackingelderlyneurocognitive disordersusabilityuser experience

Outcome Measures

Primary Outcomes (1)

  • Success rate of the Digitrack use

    The number of patients able to complete the training and evaluation phases with the Digitrack, consisting of the exploration of 3 and at least 20 images respectively.

    after 5 minutes of Digitrack use

Secondary Outcomes (3)

  • User experience assessed with the AttrakDiff scale

    after 5 minutes of Digitrack use

  • User experience assessed with the modular evaluation of the Components of User Experience (meCUE) questionnaire

    after 5 minutes of Digitrack use

  • User engagement

    after 5 minutes of Digitrack use

Interventions

User experience is assessed by validated scales

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients meeting the eligibility criteria over the study period.

You may qualify if:

  • Men or women ≥ 75 years old
  • Consultation or hospitalization in geriatrics department
  • Subjects who can give written consent to participate in the study

You may not qualify if:

  • Photosensitive epilepsy
  • Uncorrected visual deficiency
  • Any significative impairment at the upper limb level preventing from manipulating the device
  • Persons deprived of their liberty by administrative or judicial decision, persons under psychiatric care under duress, adults subject to a legal protection measure or unable to express their consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49000, France

Location

Related Publications (2)

  • Lio G, Fadda R, Doneddu G, Duhamel JR, Sirigu A. Digit-tracking as a new tactile interface for visual perception analysis. Nat Commun. 2019 Nov 26;10(1):5392. doi: 10.1038/s41467-019-13285-0.

    PMID: 31772154BACKGROUND
  • Chi MTH, Wylie R. The ICAP Framework: Linking Cognitive Engagement to Active Learning Outcomes. Educational Psychologist. 2014; 49:219-243.

    BACKGROUND

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 27, 2023

Study Start

September 15, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

IPD are not planned to be shared with other researchers

Locations