- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04113577
COgilus Remediation in Alzheimer Patients (CORA) (CORA)
COgilus Remediation in Alzheimer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Cedric ANNWEILER, MD, PhD
- Phone Number: +33 0241354725
- Email: allegro@chu-angers.fr
Study Locations
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-
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Angers, France, 49933 cedex 9
- Angers University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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:
- depression (geriatric depression scale 15 items: over 10/15)
- delirum (assessed with the confusion assessment methode)
- to be under legal protection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
geriatric inpatients with neurocognitive disorder
usability assessment after 30 minutes to test the app
|
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.
|
unformal cargivers
usability assessment after 30 minutes to test the app with their relatives
|
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.
|
health professionals
usablity assessment after the enrollement of all patients and unformal caregivers
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability regarding the Cogilus app
Time Frame: after 30 minutes of test of the 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction regarding the Cogilus app
Time Frame: after 30 minutes of test of the 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.
|
after 30 minutes of test of the app
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Global ergonomics regarding the Cogilus app
Time Frame: after 30 minutes of test of the 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.
|
after 30 minutes of test of the app
|
Ergonomics regarding the exercices proposed in the Cogilus app
Time Frame: after 30 minutes of test of the 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.
|
after 30 minutes of test of the app
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cedric ANNWEILER, MD, PhD, Angers University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/39
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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