Patient SatisfactionCORANCT04113577
COgilus Remediation in Alzheimer Patients (CORA)
An observational study of Patient Satisfaction and Neurocognitive Disorders, run by University Hospital, Angers at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Neurocognitive Disorders
- What is being tested?
- usability survey
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2019to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- depression (geriatric depression scale 15 items: over 10/15)
- delirum (assessed with the confusion assessment methode)
- to be under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COgilus Remediation in Alzheimer Patients
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.
- Conditions
- Patient Satisfaction, Neurocognitive Disorders
- Being tested
- usability survey
- Keywords
- old people, elderly, minor neurocognitive disorder, major neurocognitive disorder, neurocognitive disorder, mild cogntitive impairment, MCI, alzheimer disease, app, usability, ergonomic, satisfaction
- Medical subject headings
- Patient Satisfaction, Neurocognitive Disorders, Alzheimer Disease, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usability surveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| geriatric inpatients with neurocognitive disorder | usability assessment after 30 minutes to test the app Receives: Other: usability survey | |
| unformal cargivers | usability assessment after 30 minutes to test the app with their relatives Receives: Other: usability survey | |
| health professionals | usablity assessment after the enrollement of all patients and unformal caregivers Receives: Other: usability survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 30 minutes of test of the app
Secondary outcomes (3)
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.
Measured: after 30 minutes of test of the app
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.
Measured: after 30 minutes of test of the app
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.
Measured: after 30 minutes of test of the app
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start30 Oct 2019 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cedric ANNWEILER, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113577
- Sponsor's protocol ID
- 2019/39
- Acronym
- CORA
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COgilus Remediation in Alzheimer Patients
- ClinicalTrials.gov ID
- NCT04113577
- Acronym / sponsor ID
- CORA / 2019/39
- Conditions
- Patient Satisfaction, Neurocognitive Disorders
- Keywords
- old people, elderly, minor neurocognitive disorder, major neurocognitive disorder, neurocognitive disorder, mild cogntitive impairment, MCI, alzheimer disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| geriatric inpatients with neurocognitive disorder | – | Other: usability surveyusability assessment after 30 minutes to test the app |
| unformal cargivers | – | Other: usability surveyusability assessment after 30 minutes to test the app with their relatives |
| health professionals | – | Other: usability surveyusablity assessment after the enrollement of all patients and unformal caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- depression (geriatric depression scale 15 items: over 10/15)
- delirum (assessed with the confusion assessment methode)
- to be under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usability surveyusability survey composed of subpart: System Usability Scale, questions about global ergonomics of the app, questions about eronomics of the exerecices, question about global satisfaction. | Other | geriatric inpatients with neurocognitive disorder, health professionals, unformal cargivers |
Primary outcome
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.
3 secondary outcomes
Satisfaction regarding the Cogilus app
Time frame: after 30 minutes of test of the app
Global ergonomics regarding the Cogilus app
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedric ANNWEILER, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Neurocognitive Disorders, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cedric ANNWEILER, MD, PhD (0241354725 ext. +33, allegro@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability regarding the Cogilus app (time frame: after 30 minutes of test of the app). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.