Clinical trial NCT04255329: Non Verbal Communication and Dementia
Official title: Comparative Study of Two Cognitive Stimulation Approaches Using the Non-verbal Communication on People With Alzheimer's Disease and/or Related Diseases at a Moderate to Advanced Stage of Evolution
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neurocognitive Disorders
Alzheimer Disease
Keywords: Non pharmacological interventions
Cognitive stimulation
Non-verbal communication
Montessori Lifestyle
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2020-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cognitive impairements in Alzheimer's and apparented disorders may lead to the decreased engagement in activities, spetially in moderate and advanced stages of evolution. The lack of stimulation for people with dementia is associated with the risk of challenging behaviors, depressives symptoms, sleeping disorders or faster cognitive deterioration. Those challenges may lead to the increased administration of pharmacological treatments, though the risks of neurleptics use in this population are currently known. In this context, non-pharacological interventions hold a significant place in dementia care.

This research focuses on cognitve stimulation activities. More precisly, our study compares two aproaches using the reading groups. The first type (" usual " reading group) is based on the principle of stimulating those cognitive functions which dicreases with the evolution of dementia. The second (Montessori reading group) approach relies on the idea to use preserved capacities in order to compensate the cognitive impariments.

The aim of our study is to compare the impact of these two non-pharmalogical interventions on non-verbal communication. The collected datas will help analyzing and understanding the internal and behavioral states of people living with dementia. Our study will also extend relfexions about cognitive stimulation groups in care institutions.


Eligibility criteria: Inclusion Criteria:

* 65 years and more
* Diagnosed with Alzheimer's disease and/or related disease (frontotemporal dementia, vascular dementia, multiple etiologies dementia, Lewy's Body dementia) according to DSM-IV-TR criteria (2005)
* MMSE ≤ 15
* Good reading ability assessed using Montessori Reading Test (ability to read text written in Arial 40)
* The written agreement of the patient, primary caregiver or curator or or guardian to participate in the study and to make a film about the participant.
* Patient receiving social security benefits

Exclusion Criteria:

* Previously known associated psychotic disorder
* Deafness not compensated by hearing aid
* Extrapyramidal syndrome diagnosed by a practitioner
* Tendency to daytime sleepiness (Score 6 on the Karolinska somnolence scale)
* Patient with disruptive behaviour disorders such as screaming and/or motor agitation likely to affect the smooth running of the workshop
* Subject deprived of liberty by judicial or administrative decision.
* Subject under exclusion for another research protocol.
* Presence of motor stereotypes
* Patient receiving State Medical Assistance (AME)
* Patient under Justice Safeguard
* If the patient or guardian cannot be given informed information

Primary outcomes:
measure: gestuality frequency
timeFrame: 18 months
measure: gestuality duration
timeFrame: 18 months
Secondary outcomes:
measure: score in Observed Emotions Scale
timeFrame: 18 months
measure: Score in Menorah Park Engagement Scale
timeFrame: 18 months
measure: Participants satisfaction
timeFrame: 18 months
measure: Score in NeuroPsychiatric Inventory
timeFrame: 18 months
measure: Score in Cornell depression Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: CHU of Montpellier
name: Marie-Suzanne LEGLISE, MD
role: PRINCIPAL_INVESTIGATOR
References: