Virtual Reality Intervention for the Reduction of Behavioral and Psychological Symptoms of Dementia
NCT ID: NCT04769024
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2022-12-02
2024-03-04
Brief Summary
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The main objective of this study is to evaluate the effect of the LUMEEN Evasion module on the occurrence of BPSD in older adults living in residential aged care.
Participants will be recruited in nursing homes and randomly assigned to the LUMEEN intervention group or the control group. Participants in the LUMEEN intervention group will attend 12 LUMEEN group session s in which they will be immersed for a few minutes in a selection of landscapes or scenes using virtual reality head-mounted displays and will then have a group discussion about the immersive experience they watched during the session. Participants in the control group will attend 12 non-digital (sensory, social, cognitive, creative) stimulation group sessions in which they will carry out typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…).
The BPSD will be evaluated by the healthcare team before the start of the intervention and after the 12 sessions in both arms of the study (LUMEEN intervention and control) using the Neuropsychiatric Inventory filled out by the nursing staff (NPI). LUMEEN sessions are expected to reduce BPSD (especially apathy) more than control sessions. Thus, participants in the LUMEEN intervention group should have a greater difference between baseline and post-intervention NPI scores than the participants in the control group (in the direction of a reduction of the symptoms in the post-intervention evaluation).
Secondary outcomes will also be measured focusing on apathy, well-being and social interactions. First of all, apathy will be evaluated thanks to the Apathy Inventory - Clinician before and after the interventions in both groups. Then, the state of well-being of the participant will be evaluated thanks to the EVIBE scale completed before and after each session. In addition, social interaction behaviors will be rated using the Social Behaviour Resident Index (SOBRI), collected through a 4-minutes participant observation during each session by an external observer.
LUMEEN sessions are expected to improve these three outcomes more than control sessions. Differences are expected to be observed between the two groups : a) apathy should be lower after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group; b) well-being should be (in average) higher after the sessions than before and the pre-post-intervention difference should be larger in the LUMEEN intervention group than in the control group ; and c) there should be, on average, more social interactions behaviours during the LUMEEN sessions than during the control sessions.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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LUMEEN intervention
Participants in the LUMEEN intervention group will participate in the 12 LUMEEN Virtual Reality sessions of 45 minutes taking place twice a week for 6 weeks, in groups of 6 participants. The content of these sessions is described in the Intervention Description part of this document.
LUMEEN Virtual Reality sessions
It will consist in carrying out 12 virtual reality sessions in groups of 6 participants, at a rate of 2 per week for approximately 6 weeks, using the LUMEEN "EVASION" module. Each session lasts approximately 45 minutes. This module allows the simultaneous broadcasting in virtual reality headsets of 360° videos accompanied by music about different themes: nature, animals, travel, art and live performance.
The course of an EVASION session is as follows:
1. The participants are seated in armchairs in an open environment and sufficiently spaced so that they can move their arms without bumping into each other.
2. The facilitator announces the immersion theme of the session
3. Participants are equipped with virtual reality head-mounted displays.
4. Participants watch the content.
5. The head-mounted displays are removed.
6. A group discussion encouraging participants to share their feelings and what they have learned from the immersion is conducted by the facilitator.
USUAL activities
Participants in the control group will participate in the 12 Control/non-digital stimulation sessions of 45 minutes taking place twice a week for 6 weeks, in groups of 6 participants instead of the LUMEEN Virtual Reality sessions. The content of these sessions is described in the Intervention Description part of this document.
Control/non-digital stimulation sessions
It will consist in non-digital stimulation (sensory, social, cognitive, creative) group sessions offering various typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…). A set of activities with instructions will be provided to the investigating centres but the choice of activities in each session will be left to the facilitator's decision in order to adapt the sessions to the participants' desires and abilities, as is usually done in such stimulation groups. The sessions will last 45 minutes and will be offered twice a week for 6 weeks by a facilitator or a caregiver with group care training. The sessions will be organized in groups of 6 participants to match the group size of the intervention groups.
Interventions
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LUMEEN Virtual Reality sessions
It will consist in carrying out 12 virtual reality sessions in groups of 6 participants, at a rate of 2 per week for approximately 6 weeks, using the LUMEEN "EVASION" module. Each session lasts approximately 45 minutes. This module allows the simultaneous broadcasting in virtual reality headsets of 360° videos accompanied by music about different themes: nature, animals, travel, art and live performance.
The course of an EVASION session is as follows:
1. The participants are seated in armchairs in an open environment and sufficiently spaced so that they can move their arms without bumping into each other.
2. The facilitator announces the immersion theme of the session
3. Participants are equipped with virtual reality head-mounted displays.
4. Participants watch the content.
5. The head-mounted displays are removed.
6. A group discussion encouraging participants to share their feelings and what they have learned from the immersion is conducted by the facilitator.
Control/non-digital stimulation sessions
It will consist in non-digital stimulation (sensory, social, cognitive, creative) group sessions offering various typical pen-and-paper activities for this public which mainly stimulate language, immediate memory, semantic memory, and visual recognition (e.g., definitions, games of 7 differences, reconstruction of proverbs, quizzes…). A set of activities with instructions will be provided to the investigating centres but the choice of activities in each session will be left to the facilitator's decision in order to adapt the sessions to the participants' desires and abilities, as is usually done in such stimulation groups. The sessions will last 45 minutes and will be offered twice a week for 6 weeks by a facilitator or a caregiver with group care training. The sessions will be organized in groups of 6 participants to match the group size of the intervention groups.
Eligibility Criteria
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Inclusion Criteria
* The behavioural disorders do not prevent the participation in a session.
* For participants able to give consent:
* Written informed consent to participate in the study
* Informed consent of the participant in the presence of his/her curator for participant under curatorship.
* For participants who are not able to receive information and to give consent:
* Written informed consent of the legal representative (tutor) for participants under tutelage.
* Signature of a relative (family member and/or trusted person) of the participant
* The participant has to be affiliated to a social security scheme.
Exclusion Criteria
* Neurological disorder of infectious origin
* Psychiatric disorder
* Substance abuse
* Severe uncompensated sensory deficit
* History of epilepsy
* Pacemaker or severe and/or uncontrolled heart disease (at the discretion of the investigator)
* Visual hallucinations
* Burns and sores on the upper face or scalp
* Unable to express their consent, without a trusted person (family or close friend) and not legally protected
60 Years
100 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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EHPAD du Centre Hospitalier du Pays de Craponne Sur Arzon
Craponne-sur-Arzon, , France
EHPAD du Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
EHPAD Saint-Joseph
Le Puy-en-Velay, , France
EHPAD Maison Saint-François d'Assise Lyon
Lyon, , France
EHPAD Korian Saison Dorée
Lyon, , France
EHPAD Korian Les Aurélias
Pollionnay, , France
Countries
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Other Identifiers
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69HCL20_1246
Identifier Type: -
Identifier Source: org_study_id