search
Back to results

Non Verbal Communication and Dementia (GEMAN)

Primary Purpose

Neurocognitive Disorders, Alzheimer Disease

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Montessori reading roundtable
Usual reading
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurocognitive Disorders focused on measuring Non pharmacological interventions, Cognitive stimulation, Non-verbal communication, Montessori Lifestyle

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Usual reading group

Montessori reading roundtable group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2019
Last Updated
December 29, 2021
Sponsor
University Hospital, Montpellier
Collaborators
University of Geneva, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT04255329
Brief Title
Non Verbal Communication and Dementia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
health context of covid-19
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University of Geneva, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders, Alzheimer Disease
Keywords
Non pharmacological interventions, Cognitive stimulation, Non-verbal communication, Montessori Lifestyle

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual reading group
Arm Type
Other
Arm Description
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.
Arm Title
Montessori reading roundtable group
Arm Type
Other
Arm Description
The group counts four participants and one activity leader. Each person have the same Montessori reading roundtable book.
Intervention Type
Other
Intervention Name(s)
Montessori reading roundtable
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual reading
Intervention Description
The readen text is a normal, currently used in a everyday life support such as a journal article.
Primary Outcome Measure Information:
Title
gestuality frequency
Description
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.
Time Frame
18 months
Title
gestuality duration
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
score in Observed Emotions Scale
Description
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).
Time Frame
18 months
Title
Score in Menorah Park Engagement Scale
Description
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)
Time Frame
18 months
Title
Participants satisfaction
Description
satisfaction self reported by participants by circle one of the tree smiley (sad ; neutral; happy)
Time Frame
18 months
Title
Score in NeuroPsychiatric Inventory
Description
score from 0 to 144, higher score indicated higher challenging behaviors (Sisco, F. et al., 2000).
Time Frame
18 months
Title
Score in Cornell depression Scale
Description
score from 0 to 38, higher score indicated higher risks of depression syndrom. (1988)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Suzanne LEGLISE, MD
Organizational Affiliation
CHU of Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non Verbal Communication and Dementia

We'll reach out to this number within 24 hrs