Neurocognitive DisordersGEMANNCT04255329
Non Verbal Communication and Dementia
A study testing Montessori reading roundtable and Usual reading in people with Neurocognitive Disorders and Alzheimer Disease, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Neurocognitive Disorders, Alzheimer Disease
- What is being tested?
- Montessori reading roundtable and Usual reading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2020to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Montessori reading roundtable, Usual reading
- Keywords
- Non pharmacological interventions, Cognitive stimulation, Non-verbal communication, Montessori Lifestyle
- Medical subject headings
- Neurocognitive Disorders, Alzheimer Disease, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montessori reading roundtableOther
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 readingOther
The readen text is a normal, currently used in a everyday life support such as a journal article.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Montessori reading roundtable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 18 months
Secondary outcomes (5)
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).
Measured: 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)
Measured: 18 months
Participants satisfaction
satisfaction self reported by participants by circle one of the tree smiley (sad ; neutral; happy)
Measured: 18 months
Score in NeuroPsychiatric Inventory
score from 0 to 144, higher score indicated higher challenging behaviors (Sisco, F. et al., 2000).
Measured: 18 months
Score in Cornell depression Scale
score from 0 to 38, higher score indicated higher risks of depression syndrom. (1988)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Why it stopped: health context of covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor
- Investigators
- Marie-Suzanne LEGLISE, MD, Principal investigator, CHU of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255329
- Sponsor's protocol ID
- RECHMPL18_0071
- Acronym
- GEMAN
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04255329
- Acronym / sponsor ID
- GEMAN / RECHMPL18_0071
- Conditions
- Neurocognitive Disorders, Alzheimer Disease
- Keywords
- Non pharmacological interventions, Cognitive stimulation, Non-verbal communication, Montessori Lifestyle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: health context of covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- Feb 2020 (estimated)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual reading group | Other | Other: Usual readingThe 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. |
| Montessori reading roundtable group | Other | Other: Montessori reading roundtableThe group counts four participants and one activity leader. Each person have the same Montessori reading roundtable book. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montessori reading roundtableSuch 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. | Other | Montessori reading roundtable group |
| Usual readingThe readen text is a normal, currently used in a everyday life support such as a journal article. | Other | Usual reading group |
Primary outcome
gestuality frequency
Time frame: 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
Time frame: 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
5 secondary outcomes
score in Observed Emotions Scale
Time frame: 18 months
Score in Menorah Park Engagement Scale
Time frame: 18 months
Participants satisfaction
Time frame: 18 months
Score in NeuroPsychiatric Inventory
Time frame: 18 months
Score in Cornell depression Scale
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Suzanne LEGLISE, MD principal investigator
CHU of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montessori reading roundtable and Usual reading in people with Neurocognitive Disorders and Alzheimer Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gestuality frequency (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.