Non Verbal Communication and Dementia

Alzheimer Disease Clinical Trial

— GEMAN  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04255329
• Other study ID #: RECHMPL18_0071
• Status: Withdrawn
• Phase: N/A
• Start date: February 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Neurocognitive Disorders

Intervention

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.
• Usual reading
The readen text is a normal, currently used in a everyday life support such as a journal article.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	University of Geneva, Switzerland

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Participants satisfaction	satisfaction self reported by participants by circle one of the tree smiley (sad ; neutral; happy)	18 months
Secondary	Score in NeuroPsychiatric Inventory	score from 0 to 144, higher score indicated higher challenging behaviors (Sisco, F. et al., 2000).	18 months
Secondary	Score in Cornell depression Scale	score from 0 to 38, higher score indicated higher risks of depression syndrom. (1988)	18 months