NCT04769024

Virtual Reality Intervention for the Reduction of Behavioral and Psychological Symptoms of Dementia

Evaluation of the Benefits of an Immersive Virtual Reality Intervention (LUMEEN) for Behavioral and Psychological Symptoms of Dementia in People Living in Residential Aged Care.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Alzheimer's disease and related disorders (AD2) are characterised by cognitive changes and Behavioural and Psychological Symptoms of Dementia (BPSD). According to the French National Authority for Health (2009), Non-Pharmacological Interventions (N PhIs) are to be favo red in the treatment of BPSD. A few NPhIs have already shown their effectiveness in the management of these symptoms, such as music therapy or multi-sensory stimulation, but these techniques require trained staff and/or adapted premises. Over the past decade, innovative techniques have emerged in the field of NPhIs. Virtual Reality (VR) is one of them. Amongst the VR tools, the LUMEEN technology offers a suitable mediation tool for older adults with disabilities which allows to show immersive experiences in calm landscapes known to bring a feeling of well-being (beach, mountain, dolphins, classical music concert, animals in nature, etc.). 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.

Conditions

• Dementia
• Alzheimer's Disease
• Neurocognitive Disorders

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-03-04
• Completion: 2024-03-04
• First posted: 2021-02-24
• Last updated: 2024-12-03

Locations

6 sites across 1 country: France