NCT04113577

Brief Summary

This study evaluates the usability of a new tablet PC application to stimulate cognitive functions. Patients hospitalized in a geriatric ward (day or complete hospitalisation) but also their informal and professional caregivers will assess the usability of the application using a structured survey.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 1, 2019

Last Update Submit

October 2, 2019

Conditions

Keywords

old peopleelderlyminor neurocognitive disordermajor neurocognitive disorderneurocognitive disordermild cogntitive impairmentMCIalzheimer diseaseappusabilityergonomicsatisfaction

Outcome Measures

Primary Outcomes (1)

  • Usability regarding the Cogilus app

    Average of the usability scores. Usability score is calculated using the responses to the validated System Usability Scale (SUS). SUS is composed of 10 questions. Each response is ranking from 0 to 5. The total score ranges between 0 and 100. It is calculted considering the sum of the result on each question multiplicated by 2. An average score equal or over 70/100 will be considered as satisfying.

    after 30 minutes of test of the app

Secondary Outcomes (3)

  • Satisfaction regarding the Cogilus app

    after 30 minutes of test of the app

  • Global ergonomics regarding the Cogilus app

    after 30 minutes of test of the app

  • Ergonomics regarding the exercices proposed in the Cogilus app

    after 30 minutes of test of the app

Study Arms (3)

geriatric inpatients with neurocognitive disorder

usability assessment after 30 minutes to test the app

Other: usability survey

unformal cargivers

usability assessment after 30 minutes to test the app with their relatives

Other: usability survey

health professionals

usablity assessment after the enrollement of all patients and unformal caregivers

Other: usability survey

Interventions

usability survey composed of subpart: System Usability Scale, questions about global ergonomics of the app, questions about eronomics of the exerecices, question about global satisfaction.

geriatric inpatients with neurocognitive disorderhealth professionalsunformal cargivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are recruited during their complet or day hospitalisation in geriatric medicine. Relatives / unformal caregivers are recruited during the hospitalisation of patients in geriatric medicine. Professionnal caregivers are recruited in the acute care geriatric unit or in the day hospitalisation geriatric unit.

You may qualify if:

  • no opposition to be part of the study
  • patients:
  • over 65 years old
  • to be hospitalised in geriatric medicine department of Angers University Hospital
  • mild cognitive impairment (winblad criterion) or minor neurocognitive disorder du to alzheimer disease or early major neurocognitive disorder du to alzheimer disease (DSM V and NINCDS-ADRDA criterion)
  • unformal cargivers and health profesionnals:
  • over 18 years old

You may not qualify if:

  • depression (geriatric depression scale 15 items: over 10/15)
  • delirum (assessed with the confusion assessment methode)
  • to be under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49933 cedex 9, France

Location

MeSH Terms

Conditions

Patient SatisfactionNeurocognitive DisordersAlzheimer DiseasePersonal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Cedric ANNWEILER, MD, PhD

    Angers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cedric ANNWEILER, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 2, 2019

Study Start

October 30, 2019

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations