NCT04769024Befejeződött
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.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. dec. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 56 (tényleges)
- Első benyújtás
- 2021. febr. 8.
- Kezdés
- 2022. dec. 2.
- Elsődleges befejezés
- 2024. márc. 4.
- Fő szponzor
- Hospices Civils de Lyon
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT04769024
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 56
- 2022. dec. 2. és az elsődleges befejezés (2024. márc. 4.) között
- 6 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Unstable pathology whose nature may interfere with the assessment variables:
- Neurological disorder of infectious origin
- Psychiatric disorder
- Substance abuse
- History of epilepsy
- Pacemaker or severe and/or uncontrolled heart disease (at the discretion of the investigator)
Egyéb
- Severe uncompensated sensory deficit
- 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
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 60 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| EHPAD du Centre Hospitalier du Pays de Craponne Sur Arzon Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Craponne-sur-Arzon | Franciaország | Ismeretlen állapot |
| EHPAD Saint-Joseph Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Le Puy-en-Velay | Franciaország | Ismeretlen állapot |
| EHPAD du Centre Hospitalier Emile Roux Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Le Puy-en-Velay | Franciaország | Ismeretlen állapot |
| EHPAD Korian Saison Dorée Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Lyon | Franciaország | Ismeretlen állapot |
| EHPAD Maison Saint-François d'Assise Lyon Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Lyon | Franciaország | Ismeretlen állapot |
| EHPAD Korian Les Aurélias Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Pollionnay | Franciaország | Ismeretlen állapot |
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