Family Caregiver of Patient With Alzheimer DiseaseNCT04573985
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
A study testing Serious game Eurekoi intervention in people with Family Caregiver of Patient With Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Caregiver of Patient With Alzheimer Disease
- What is being tested?
- Serious game Eurekoi intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2020to 6 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- Subject not speaking French, not reading French
- Subject with visual impairment
- Subject under tutorship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Serious game Eurekoi intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game Eurekoi interventionBehavioural
1 session in group using the serious game eurekoi
| Study group | Role | What they receive |
|---|---|---|
| Serious Game Eurekoi intervention | Experimental | 1 session in group using the serious game eurekoi Receives: Behavioral: Serious game Eurekoi intervention |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (2)
Change of knowledge of familial caregiver about cognitive troubles
Multiple choice questionary
Measured: 3 months
Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI
questionary of satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start8 Dec 2020
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Caregiver of Patient With Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573985
- Sponsor's protocol ID
- 19-AOI-09
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2020
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
- ClinicalTrials.gov ID
- NCT04573985
- Acronym / sponsor ID
- 19-AOI-09
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 5 Oct 2020 (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 aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious Game Eurekoi intervention | Experimental | Behavioral: Serious game Eurekoi intervention1 session in group using the serious game eurekoi |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Subject not speaking French, not reading French
- Subject with visual impairment
- Subject under tutorship or curatorship.
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 |
|---|---|---|
| Serious game Eurekoi intervention1 session in group using the serious game eurekoi | Behavioural | Serious Game Eurekoi intervention |
Primary outcome
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)
2 secondary outcomes
Change of knowledge of familial caregiver about cognitive troubles
Time frame: 3 months
Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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RecruitingObservational study
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Alzheimer Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game Eurekoi intervention in people with Family Caregiver of Patient With Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice 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 3 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacity of the serious game Eurekoi on anxiety of familial caregiver of patient with Alzheimer Disease (time frame: 3 months). 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 18 Nov 2023.