Non Verbal Communication and Dementia (GEMAN)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Neurocognitive Disorders; Alzheimer Disease
• Intervention / Treatment: Other: Usual reading; Other: Montessori reading roundtable

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Usual reading group; The leader of the activity reads aloud a text to four participants seated around the table. The readen text is a normal, currently used in a everyday life support such as a journal article. Consequently it is not previously adaptated to people with cognitive impairements. After the reading phase, the leader asks the participants the questions about the content.	Other: Usual reading; The readen text is a normal, currently used in a everyday life support such as a journal article.
OTHER: Montessori reading roundtable group; The group counts four participants and one activity leader. Each person have the same Montessori reading roundtable book.	Other: Montessori reading roundtable; Such book is written in a way to adaptate to people with cognitif and sensory impairments. Indeed, text is written in large characters and structured to not involve episodic memory. Each person read one page aloud in his turn. After the reading phase, the participants discuss the questions about their opinions and distant memories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gestuality frequency	frequency of gestures (number of gestures observed) unrelated with the activity (item manipulations unrelated with the activity, comfort posture, self-focus gestures, look outside the interaction space) measured by ANVIL software.	18 months
gestuality duration	duration of gestures (duration of gestures observed in seconds) unrelated with the activity (item manipulations unrelated with the activity, comfort posture, self-focus gestures, look outside the interaction space) measured by ANVIL	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score in Observed Emotions Scale	Duration of signs of pleasure, anger, anxiety/fear, sadness and general alertness over en ten-imunt observation period in a 6 item scale : not in view ; never ; less than 16 sec. ; 16-59 sec. ; 1-5 min. ; more than 5 min. (Lawton, M.P., Van Haitsma, K. & Klapper, J.A (1999).	18 months
Score in Menorah Park Engagement Scale	reported participants engagement thanks to a 6 questions questionnaire : did the participant take part in the activity (yes/no) ; how long did the participant realise or comment the activity, listen/look the activity, do other things, sleep/keep eyes closed, expresse pleasure (not at all ; less than half of the time ; more than half of the time) (Camp, 2004)	18 months
Participants satisfaction	satisfaction self reported by participants by circle one of the tree smiley (sad ; neutral; happy)	18 months
Score in NeuroPsychiatric Inventory	score from 0 to 144, higher score indicated higher challenging behaviors (Sisco, F. et al., 2000).	18 months
Score in Cornell depression Scale	score from 0 to 38, higher score indicated higher risks of depression syndrom. (1988)	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University of Geneva, Switzerland
• Investigators: Principal Investigator: Marie-Suzanne LEGLISE, MD, CHU of MONTPELLIER

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ACTUAL): September 27, 2021
• Study Completion (ACTUAL): September 27, 2021

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Cognitive stimulation; Non-verbal communication; Non pharmacological interventions; Montessori Lifestyle
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Neurocognitive Disorders
• Other Study ID Numbers: RECHMPL18_0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No