Non Verbal Communication and Dementia

NCT04255329 | Withdrawn

• 1 other identifier: RECHMPL18_0071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders; Alzheimer Disease

Keywords

Non pharmacological interventions; Cognitive stimulation; Non-verbal communication; Montessori Lifestyle

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• score in Observed Emotions Scale

  18 months

• Score in Menorah Park Engagement Scale

  18 months

• Participants satisfaction

  18 months

• Score in NeuroPsychiatric Inventory

  18 months

• Score in Cornell depression Scale

  18 months

Study Arms (2)

Usual reading group

OTHER

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

Montessori reading roundtable group

OTHER

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

Other: Montessori reading roundtable

Interventions

Montessori reading roundtable OTHER

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.

Montessori reading roundtable group

Usual reading OTHER

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

Usual reading group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Presence of motor stereotypes
• Patient receiving State Medical Assistance (AME)
• Patient under Justice Safeguard
• If the patient or guardian cannot be given informed information

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University of Geneva, Switzerland: collaborator

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Neurocognitive Disorders; Alzheimer Disease; Nonverbal Communication

Condition Hierarchy (Ancestors)

Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Communication; Behavior

Study Officials

• Marie-Suzanne LEGLISE, MD

  CHU of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: February 5, 2020
• Study Start: February 1, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)