- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573985
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
November 15, 2023 updated by: Centre Hospitalier Universitaire de Nice
This study aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Philippe ROBERT, PU-PH
- Phone Number: 0492034762
- Email: robert.ph@chu-nice.fr
Study Contact Backup
- Name: Julie BROUSSE
- Phone Number: 0033 0492034762
- Email: brousse.j@chu-nice.fr
Study Locations
-
-
-
Nice, France
- CHU de Nice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Men or women over 18 years old;
- Primary caregiver of a patient with a mild-stage major neurocognitive disorder newly diagnosed according to the DSM 5 criteria;
- Signature of informed consent.
Exclusion Criteria:
- Subject not speaking French, not reading French
- Subject with visual impairment
- Subject under tutorship or curatorship.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
no intervention
|
|
Experimental: Serious Game Eurekoi intervention
1 session in group using the serious game eurekoi
|
1 session in group using the serious game eurekoi
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacity of the serious game Eurekoi on anxiety of familial caregiver of patient with Alzheimer Disease
Time Frame: 3 months
|
Auto-evaluation of anxiety using Spielberger inventory (score between 20 and 80 ; the higher the score, the greater the anxiety)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of knowledge of familial caregiver about cognitive troubles
Time Frame: 3 months
|
Multiple choice questionary
|
3 months
|
Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI
Time Frame: 3 months
|
questionary of satisfaction
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2020
Primary Completion (Actual)
September 6, 2022
Study Completion (Actual)
September 6, 2022
Study Registration Dates
First Submitted
September 22, 2020
First Submitted That Met QC Criteria
September 28, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-AOI-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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