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Status unknownNCT04113577CORAUpdated Oct 4, 2019

COgilus Remediation in Alzheimer Patients (CORA)

An observational study in Patient Satisfaction and Neurocognitive Disorders, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-04.

Sponsored by University Hospital, Angers · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Attention span is one of the most frequently and early impaired cognitive functions during aging, especially in neurocognitive disorders such as Alzheimer's disease. Decline of attention span can lead to a cognitive complaint by the patient or his or her relatives, even in the prodromal phase of the disease (DSM V: minor neurocognitive disorder). The current challenge is to develop strategies to prevent the cognitive decline in patients with minor neurocognitive disorder or major cognitive disorder with slight impairment, and thus to limit cognitive decline. However, to date, no strategy has shown clear effectiveness in preventing cognitive decline in patients with neurocognitive disorder.

Interestingly, the integration of perceptual skills are modified in patients with neurocognitive disorders, and in particular visuomotor skills (from early stages). Measurements of evoked potientials during visual stimulation in patients with minor neurocognitive disorder have shown a preservation of sensory responses but a decrease in cognitive responses. Based on this observation, a US team had recently tested the effectiveness of computer-based visual cognitive exercises performed regularly for 8 weeks in patients free of major neurocognitive disorder. They had reported an improvement in information processing speed and walking performance. These results suggest that regular cognitive stimulation exercises using tablet PC visual exercices could improve attention span and in particular the information processing speed in patient with minor or early major neurocognitive disorder.

In particular, Cogilus, a cross-platform tablet PC application (Android, iOS, Microsoft) has recently been developed for this purpose. The Cogilus project, is designed for health professionals who support patients with neurological syndromes including cognitive or attentional dysfunctions. The application is also open to carers and family members, who will be able to support the patient in using the application (based on the exercices proposed by professionals).

The finale objective of the Cogilus project is to assess the impact of the regular use of Cogilus on patient with minor or early major neurocognitive disorder. Considering the specific needs in usability for this population, the first step to devoloppe such technology is to assess the usability of the application in patients but also in unformal and professional cargivers.

02

Conditions studied

  • Patient Satisfaction
  • Neurocognitive Disorders

Keywords

  • old people
  • elderly
  • minor neurocognitive disorder
  • major neurocognitive disorder
  • neurocognitive disorder
  • mild cogntitive impairment
  • MCI
  • alzheimer disease
  • app
  • usability
  • ergonomic
  • satisfaction
03

In context

Patient Satisfaction

278 studies on the registry are indexed under Patient Satisfaction; 130 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 63 observational studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • depression (geriatric depression scale 15 items: over 10/15)
  • delirum (assessed with the confusion assessment methode)
  • to be under legal protection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherusability survey

    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.

06

What researchers measure

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.

    Time frame: after 30 minutes of test of the app

Secondary outcomes

  1. Satisfaction regarding the Cogilus app

    Average recommendation score. Satisfaction score is calculated using the responses to the recommendation scale. This scale is a ten point's scale from 0 (I don't recommend at all) to 10 (I fully recommend). An average score greater than 5/10 would be acceptable, a score greater than or equal to 7/10 would be satisfactory.

    Time frame: after 30 minutes of test of the app

  2. Global ergonomics regarding the Cogilus app

    Average ergonomics score: The ergonomics score is a composite score based on the average of the answers to four ergonomics questions on a four-level Likert scale. The Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The average score is reported on ten. An average score greater than 5/10 would be acceptable, a score greater than or equal to 7/10 would be satisfactory.

    Time frame: after 30 minutes of test of the app

  3. Ergonomics regarding the exercices proposed in the Cogilus app

    Average ergonomics score: The ergonomics score is a composite score based on the average of the answers to four ergonomics questions on a four-level Likert scale. The Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The average score is reported on ten. An average score greater than 5/10 would be acceptable, a score greater than or equal to 7/10 would be satisfactory.

    Time frame: after 30 minutes of test of the app

07

Study locations

1 site
  • Angers University Hospital
    Angers, 49933 cedex 9, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2019; primary completion for Oct 2020, 12 months later.

Of 32 observational studies under Patient Satisfaction, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2019
First posted
Oct 2, 2019
StartEst.
Oct 30, 2019
Primary completionEst.
Oct 30, 2020
CompletionEst.
Oct 30, 2020
Last update
Oct 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04113577
Responsible party
Sponsor
First posted
Oct 2, 2019
Start date
Oct 30, 2019 (estimated)
Primary completion
Oct 30, 2020 (estimated)
Completion
Oct 30, 2020 (estimated)
Last update
Oct 4, 2019

Study contacts

Cedric ANNWEILER, MD, PhD
Contact
allegro@chu-angers.fr
0241354725 ext. +33
Cedric ANNWEILER, MD, PhD
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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