LUMEENCOMPAD: Evaluation of the Effectiveness of the LUMEEN System on Behavioral Disorder of People Affected With Dementia

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04769024

Collaborator

(none)

Enrollment

Arms

11.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Alzheimer's disease and related diseases are characterized by cognitive changes and the behavioral and psychological symptoms of dementia (BPSD). According to the Haute Autorité de Santé, non-pharmacological interventions should be favored in the treatment of BPSD. Different non-pharmacological interventions have already shown their effectiveness in the management of these symptoms, such as music therapy or multisensory stimulation, but these techniques require trained personnel and / or suitable premises. Over the past decade, innovative techniques have appeared in the field of non-grug intervention. Virtual Reality (VR) is one of these. Among the VR tools, LUMEEN technology makes it possible to offer a mediation tool adapted to dependent elderly people by organizing immersion sessions in calm landscapes, and known to bring a feeling of well-being (beach, mountain, dolphins, concert classical music, animals in nature…).

The present study proposes to evaluate the effectiveness of LUMEEN immersive workshops on BPSD in elderly people living in nursing home.

Condition or Disease	Intervention/Treatment	Phase
Restlessness Anxiety Depression in Old Age Apathy in Dementia BPSD	Behavioral: LUMEEN Behavioral: USUAL activities	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of the Effectiveness of a Virtual Reality Immersion Process (LUMEEN) on Behavioral Disorders of People Living in Nursing Home

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LUMEEN activities Participants will benefit from LUMEEN activities for 8 weeks (2 session/week)	Behavioral: LUMEEN Participants will benefit from multimodal immersion sessions in relaxing scenarios. These scenarios are based on the technology developed by LUMEEN and consist of three phases. The introduction (10-20 minutes) allows you to introduce, present and discuss in a group around the chosen theme using the software support of the digital tablet. The immersion (6 to 12 minutes) simultaneously immerses the 4 participants in a real environment captured in 360 ° video accompanied by natural sounds and / or music. The conclusion (10-20 minutes) allows you to discuss the experience of the immersion, to elaborate on the feelings and to recall the information shared during the introduction or the immersion. The sessions will last about 45 minutes and will be offered twice a week for 8 weeks by a facilitator or a caregiver trained in group care. The sessions will be in groups of 4 participants.
Sham Comparator: USUAL activities Participants will benefit from the thematic group workshops for 8 weeks (2 sessions/week)	Behavioral: USUAL activities Participants will benefit from thematic group workshops: these workshops follow the themes at each session in the immersive LUMEEN workshops but the proposed activity will be done through the usual paper and pencil type activity. The sessions will last 45 minutes and will be offered twice a week for 8 weeks by a facilitator or a caregiver trained in group care. The sessions will be in groups of 4 participants.

Arm

Intervention/Treatment

Active Comparator: LUMEEN activities

Participants will benefit from LUMEEN activities for 8 weeks (2 session/week)

Behavioral: LUMEEN

Participants will benefit from multimodal immersion sessions in relaxing scenarios. These scenarios are based on the technology developed by LUMEEN and consist of three phases. The introduction (10-20 minutes) allows you to introduce, present and discuss in a group around the chosen theme using the software support of the digital tablet. The immersion (6 to 12 minutes) simultaneously immerses the 4 participants in a real environment captured in 360 ° video accompanied by natural sounds and / or music. The conclusion (10-20 minutes) allows you to discuss the experience of the immersion, to elaborate on the feelings and to recall the information shared during the introduction or the immersion. The sessions will last about 45 minutes and will be offered twice a week for 8 weeks by a facilitator or a caregiver trained in group care. The sessions will be in groups of 4 participants.

Sham Comparator: USUAL activities

Participants will benefit from the thematic group workshops for 8 weeks (2 sessions/week)

Behavioral: USUAL activities

Participants will benefit from thematic group workshops: these workshops follow the themes at each session in the immersive LUMEEN workshops but the proposed activity will be done through the usual paper and pencil type activity. The sessions will last 45 minutes and will be offered twice a week for 8 weeks by a facilitator or a caregiver trained in group care. The sessions will be in groups of 4 participants.

Outcome Measures

Primary Outcome Measures

Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) [At week 8]
The NPI-HS makes it possible to assess out of 12 each SPCD (delusions, hallucinations, agitation, depression, anxiety, elation, apathy, disinhibition, depression, aberrant motor behavior, sleep and appetite) according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: moderate, 3: significant). The score is calculated by multiplying the frequency and severity for each dimension and adding each of these sub-scores. The maximum score is 144.

Secondary Outcome Measures

Change in scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale [Before and immediately after each intervention session (each session is 45 minutes long)]
It is a visual analog scale allowing the patient to report on his state of well-being. In response to the question "How do you feel now / right now?" ", The patient will position their feeling of well-being by relying on pictograms representing simple facial expressions (joy, neutral and sadness) whose treatment is preserved late in the evolution of Alzheimer Disease. On the back, the positioning of the patient according to the pictograms is transcribed into a numerical value from 1 to 5. The answer "1" will correspond to the weakest feeling of well-being and the answer "5" to the feeling of the highest well-being.
Score obtained from the Caregiver Apathy Inventory [At week 8]
The Caregiver Apathy Inventory collects information on the presence of apathy in patients with cerebral pathologies according to three dimensions: emotional dullness, loss of initiative, loss of interest. Each dimension is assessed by a caregiver according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: medium, 3: important). The score for each dimension is calculated by multiplying the frequency by the severity, obtaining a maximum score of 12. The total score of IA-S is obtained by adding the scores of the 3 dimensions obtaining a maximum score of 36.
Score obtained from the Social Behaviour Resident Index (SOBRI) during the interventions [At week 8]
The Social Behaviour Resident Index (SOBRI) makes it possible to observe and objectify social interaction behaviors. SOBRI is made up of two components: social interactions between residents (10 types of interaction) and social interactions between residents and staff (6 types of interaction). Social interactions are analyzed in terms of presence or absence. SOBRI will be collected by a blind trained caregiver from the study. The more items are characterized as present, the more sociable the behavior displayed by the resident is.
Score obtained from the Observed Emotion Rating Scale (OERS) during the interventions [At week 8]
The OERS scale is used to assess positive and negative emotions in hetero-assessment. The observer observes the duration of observation of behaviors evoking pleasure, anger, anxiety, sadness and general vigilance. Points are awarded according to the duration of the emotions (1: never, 2: less than 16 seconds, 3: between 16 and 59 seconds, 4: between 1 minute and 5 minutes, 5: more than 5 minutes). The higher the score, the more emotion is present over the evaluation period. The OERS will be collected by a caregiver trained blind from the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Man or woman aged 60 to 100.
Score greater than or equal to 2 for at least one of the following items in the NPI-HS: apathy, agitation, anxiety, depression, and aberrant motor behavior.
Patients whose behavioral disorders allow participation in a workshop.
The patients recruited must have given themselves, or through a trusted person provided for in article L. 1111-6 of the Public Health Code, failing this, by the family, or, failing that, by a person having close and stable ties with the person concerned; for adults under guardianship: the guardian or legal representative, for adults under guardianship: the curator, their informed consent to this study which must be approved by the Personal Protection Committee (PPC) prior to its completion.

Exclusion Criteria:

Unstable pathology, the nature of which may interfere with the evaluation variables;
Deafness or blindness that could compromise the patient's assessment or his participation in intervention sessions
History of epilepsy.
Pacemaker and cardiac disorders