Back to resultsImpact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
Primary Purpose
Family Caregiver of Patient With Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious game Eurekoi intervention
Sponsored by
About this trial
This is an interventional other trial for Family Caregiver of Patient With Alzheimer Disease
Eligibility Criteria
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.
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Serious Game Eurekoi intervention
Control group
Arm Description
1 session in group using the serious game eurekoi
no intervention
Outcomes
Primary Outcome Measures
Efficacity of the serious game Eurekoi on anxiety of familial caregiver of patient with Alzheimer Disease
Auto-evaluation of anxiety using Spielberger inventory (score between 20 and 80 ; the higher the score, the greater the anxiety)
Secondary Outcome Measures
Change of knowledge of familial caregiver about cognitive troubles
Multiple choice questionary
Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI
questionary of satisfaction
Full Information
NCT ID
NCT04573985
First Posted
September 22, 2020
Last Updated
October 15, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04573985
Brief Title
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
Official Title
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
August 23, 2021 (Anticipated)
Study Completion Date
August 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Caregiver of Patient With Alzheimer Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serious Game Eurekoi intervention
Arm Type
Experimental
Arm Description
1 session in group using the serious game eurekoi
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Serious game Eurekoi intervention
Intervention Description
1 session in group using the serious game eurekoi
Primary Outcome Measure Information:
Title
Efficacity of the serious game Eurekoi on anxiety of familial caregiver of patient with Alzheimer Disease
Description
Auto-evaluation of anxiety using Spielberger inventory (score between 20 and 80 ; the higher the score, the greater the anxiety)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of knowledge of familial caregiver about cognitive troubles
Description
Multiple choice questionary
Time Frame
3 months
Title
Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI
Description
questionary of satisfaction
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe ROBERT, PU-PH
Phone
0492034762
Email
robert.ph@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie BROUSSE
Phone
0492034762
Ext
0033
Email
brousse.j@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT
Email
robert.ph@chu-nice.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
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