Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders (TOVERTAFEL)
Primary Purpose
Behavioral Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TOVERTAFEL
USUAL activities
Sponsored by
About this trial
This is an interventional supportive care trial for Behavioral Disorder focused on measuring dementia, non-drug intervention, apathy
Eligibility Criteria
Inclusion Criteria:
- Man or woman aged 60 to 106.
- Patient living in one of the USLD or UHR participating in the project.
- Score greater than or equal to 9 for at least one of the following items in the NPI-ES: apathy, agitation, anxiety, depression, aberrant motor behavior.
- Presence of TNC according to the standardization and calibration of the MMSE.
- The patients recruited must have given themselves, or through a trusted person provided for in article L. 1111-6 of the Public Health Code, failing this, by the family, or, failing that, by a person having close and stable ties with the person concerned; for adults under guardianship: the guardian or legal representative, for adults under guardianship: the curator, their informed consent to this study which must be approved by the Personal Protection Committee (PPC) prior to its completion.
Exclusion Criteria:
- Unstable pathology whose nature can interfere with the evaluation variables
- Deafness or blindness which could compromise the patient's assessment or his participation in the animation sessions.
Sites / Locations
- Hôpital des CharpennesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
group starting with TOVERTAFEL activities
group ending with TOVERTAFEL activities
Arm Description
Participants will benefit from TOVERTAFEL activities for 6 weeks then the usual animation techniques for 6 weeks with a week of wash-out between the two periods.
Participants will benefit from the usual animation techniques for 6 weeks then from TOVERTAFEL activities for 6 weeks with a week of wash-out between the two periods.
Outcomes
Primary Outcome Measures
Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention
The NPI-HS makes it possible to assess out of 12 each SPCD (delusions, hallucinations, agitation, depression, anxiety, elation, apathy, disinhibition, depression, aberrant motor behavior, sleep and appetite) according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: moderate, 3: significant). The score is calculated by multiplying the frequency and severity for each dimension and adding each of these sub-scores. The maximum score is 144. Responses to the NPI-ES are collected from the healthcare team by a psychologist before the start of the intervention, then at 6 weeks and 13 weeks of inclusion.
Secondary Outcome Measures
Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale
It is a visual analog scale allowing the patient to report on his state of well-being. In response to the question "How do you feel now / right now?" ", The patient will position their feeling of well-being by relying on pictograms representing simple facial expressions (joy, neutral and sadness) whose treatment is preserved late in the evolution of Alzheimer Disease. On the back, the positioning of the patient according to the pictograms is transcribed into a numerical value from 1 to 5. The answer "1" will correspond to the weakest feeling of well-being and the answer "5" to the feeling of the highest well-being.
Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention
The Caregiver Apathy Inventory collects information on the presence of apathy in patients with cerebral pathologies according to three dimensions: emotional dullness, loss of initiative, loss of interest. Each dimension is assessed by a caregiver according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: medium, 3: important). The score for each dimension is calculated by multiplying the frequency by the severity, obtaining a maximum score of 12. The total score of IA-S is obtained by adding the scores of the 3 dimensions obtaining a maximum score of 36.
Evolution of the consumption of psychotropic drugs before the start of the intervention
The evolution of the number of antidepressant, antipsychotic, anxiolytic and hypnotic drugs per patient will be compared according to the period (Tovertafel or usual animation techniques). For the patients concerned, the consumption of benzodiazepines translated into the administered dose equivalent to oxazepam will also be compared.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04421833
Brief Title
Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders
Acronym
TOVERTAFEL
Official Title
Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders of People With Cognitive Disorders Hospitalized in Long-Term Care Units and in Reinforced Hosting Unit
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The prevalence of behavioral disorders is high in patients living in an institutional environment or hospitalized in a long-term care unit. The consequences of these symptoms are not negligible with a faster cognitive decline and a significant impact on the life of the institution and of other patients when the disorders are pervasive and too difficult to manage for the healthcare teams.
Despite the daily attention paid to these disorders and their causes, especially the environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today to fight against these symptoms, and their management thus constitutes a real challenge.
Non-drug interventions targeting this problem often require additional training, architectural installations (Snoezelen space) and / or are moderately effective. In order to offer a solution that can be used by everyone, that is transportable and based on new technologies, the TOVERTAFEL device was created.
These are interactive games projected onto a table using a ceiling projector. The light animations invite people to "play with the light" using arm or hand movements. These games stimulate residents' physical activity and encourage interactions between residents and with caregivers.
In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the quality of life of the patients, as well as on psychotropic treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Disorder
Keywords
dementia, non-drug intervention, apathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group starting with TOVERTAFEL activities
Arm Type
Active Comparator
Arm Description
Participants will benefit from TOVERTAFEL activities for 6 weeks then the usual animation techniques for 6 weeks with a week of wash-out between the two periods.
Arm Title
group ending with TOVERTAFEL activities
Arm Type
Sham Comparator
Arm Description
Participants will benefit from the usual animation techniques for 6 weeks then from TOVERTAFEL activities for 6 weeks with a week of wash-out between the two periods.
Intervention Type
Behavioral
Intervention Name(s)
TOVERTAFEL
Intervention Description
The TOVERTAFEL is a small box that can be attached to the ceiling. Inside the box is a high-quality projector, infrared sensors, a speaker, and a processor that work together to project games onto the table. Because the colored objects respond to the movements of the hands and arms, the residents can play with the light itself.
The planned activities provide cognitive, social and physical stimulation through light projections and can all be used individually or in groups with the presence of a caregiver or facilitator. Sixteen play activities are offered.
Intervention Type
Behavioral
Intervention Name(s)
USUAL activities
Intervention Description
patients can participate in cooking workshops, cinema activities (screening of old films or documentaries on a large screen, in a "cozy" atmosphere), walks in the garden and the visit of a dog trained in assisted therapy by the animal.
Primary Outcome Measure Information:
Title
Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention
Description
The NPI-HS makes it possible to assess out of 12 each SPCD (delusions, hallucinations, agitation, depression, anxiety, elation, apathy, disinhibition, depression, aberrant motor behavior, sleep and appetite) according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: moderate, 3: significant). The score is calculated by multiplying the frequency and severity for each dimension and adding each of these sub-scores. The maximum score is 144. Responses to the NPI-ES are collected from the healthcare team by a psychologist before the start of the intervention, then at 6 weeks and 13 weeks of inclusion.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale
Description
It is a visual analog scale allowing the patient to report on his state of well-being. In response to the question "How do you feel now / right now?" ", The patient will position their feeling of well-being by relying on pictograms representing simple facial expressions (joy, neutral and sadness) whose treatment is preserved late in the evolution of Alzheimer Disease. On the back, the positioning of the patient according to the pictograms is transcribed into a numerical value from 1 to 5. The answer "1" will correspond to the weakest feeling of well-being and the answer "5" to the feeling of the highest well-being.
Time Frame
before and after one intervention seance
Title
Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention
Description
The Caregiver Apathy Inventory collects information on the presence of apathy in patients with cerebral pathologies according to three dimensions: emotional dullness, loss of initiative, loss of interest. Each dimension is assessed by a caregiver according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: medium, 3: important). The score for each dimension is calculated by multiplying the frequency by the severity, obtaining a maximum score of 12. The total score of IA-S is obtained by adding the scores of the 3 dimensions obtaining a maximum score of 36.
Time Frame
6 weeks
Title
Evolution of the consumption of psychotropic drugs before the start of the intervention
Description
The evolution of the number of antidepressant, antipsychotic, anxiolytic and hypnotic drugs per patient will be compared according to the period (Tovertafel or usual animation techniques). For the patients concerned, the consumption of benzodiazepines translated into the administered dose equivalent to oxazepam will also be compared.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
106 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man or woman aged 60 to 106.
Patient living in one of the USLD or UHR participating in the project.
Score greater than or equal to 9 for at least one of the following items in the NPI-ES: apathy, agitation, anxiety, depression, aberrant motor behavior.
Presence of TNC according to the standardization and calibration of the MMSE.
The patients recruited must have given themselves, or through a trusted person provided for in article L. 1111-6 of the Public Health Code, failing this, by the family, or, failing that, by a person having close and stable ties with the person concerned; for adults under guardianship: the guardian or legal representative, for adults under guardianship: the curator, their informed consent to this study which must be approved by the Personal Protection Committee (PPC) prior to its completion.
Exclusion Criteria:
Unstable pathology whose nature can interfere with the evaluation variables
Deafness or blindness which could compromise the patient's assessment or his participation in the animation sessions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Floriane Delphin-Combe
Phone
472433135
Ext
+33
Email
floriane.delphin-combe@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain Calvi
Phone
472433135
Ext
+33
Email
sylvain.calvi@chu-lyon.fr
Facility Information:
Facility Name
Hôpital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Floriane Delphin-Combe
Phone
472433135
Ext
+33
Email
floriane.delphin-combe@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Pierre KROLAK-SALMON, Pr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders
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