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

Civil Hospices of Lyon

Status: Completed

Conditions: Alzheimer's Disease; Neurocognitive Disorders; Dementia

Treatments: Device: LUMEEN Virtual Reality sessions; Behavioral: Control/non-digital stimulation sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT04769024

69HCL20_1246

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

56 participants in 2 patient groups

LUMEEN intervention

Active Comparator group

Description:

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.

Treatment:

Device: LUMEEN Virtual Reality sessions

USUAL activities

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Control/non-digital stimulation sessions