Non Verbal Communication and Dementia

Not Applicable

Withdrawn

• Conditions: Neurocognitive Disorders; Alzheimer Disease
• Interventions: Other: Montessori reading roundtable; Other: Usual reading

• Registration Number: NCT04255329
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study Start: 2020-02
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Montessori reading roundtable group	Montessori reading roundtable	The group counts four participants and one activity leader. Each person have the same Montessori reading roundtable book.
Usual reading group	Usual reading	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.

Primary Outcome Measures

Name	Time	Method
gestuality frequency	18 months	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.
gestuality duration	18 months	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

Secondary Outcome Measures

Name	Time	Method
Score in NeuroPsychiatric Inventory	18 months	score from 0 to 144, higher score indicated higher challenging behaviors (Sisco, F. et al., 2000).
Score in Menorah Park Engagement Scale	18 months	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)
score in Observed Emotions Scale	18 months	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).
Participants satisfaction	18 months	satisfaction self reported by participants by circle one of the tree smiley (sad ; neutral; happy)
Score in Cornell depression Scale	18 months	score from 0 to 38, higher score indicated higher risks of depression syndrom. (1988)

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France