Clinical trial NCT04769024: Virtual Reality Intervention for the Reduction of Behavioral and Psychological Symptoms of Dementia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer's Disease
Neurocognitive Disorders
Keywords: BPSD
Dementia
Apathy
virtual reality
Alzheimer's disease
Neurocognitive Disorders
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Participants will have to present a NPI score of 9 or more on at least one of the following items : apathy, agitation, anxiety, depression, aberrant motor behavior.
* 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 :

* Unstable pathology whose nature may interfere with the assessment variables:

  * 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

Primary outcomes:
measure: Differences in Neuropsychiatric Inventory filled out by the nursing staff (NPI) score between before and after the intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Differences between the mean EVIBE scores before the sessions and the mean EVIBE scores after the sessions compared between the two groups (Lumeen intervention and control).
timeFrame: 12 weeks
measure: Differences between scores on the Apathy Inventory - Clinician (AI-Clinician) completed before and after the 12 intervention sessions, compared between the LUMEEN intervention group and the control group.
timeFrame: 12 weeks
measure: Mean of the Social Behaviour Resident Index (SOBRI) scores completed during each session, compared between LUMEEN intervention and control groups
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Craponne sur Arzon
country: France
facility: EHPAD du Centre Hospitalier du Pays de Craponne Sur Arzon
city: Le Puy-en-Velay
country: France
facility: EHPAD du Centre Hospitalier Emile Roux
city: Le Puy-en-Velay
country: France
facility: EHPAD Saint-Joseph
city: Lyon
country: France
facility: EHPAD Maison Saint-François d'Assise Lyon
city: Lyon
country: France
facility: EHPAD Korian Saison Dorée
city: Pollionnay
country: France
facility: EHPAD Korian Les Aurélias
Study officials:
References: