Clinical trial NCT04421833: Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders
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
Overall status: UNKNOWN
Phase: NA
Conditions: Behavioral Disorder
Keywords: dementia
non-drug intervention
apathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 106
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale
timeFrame: before and after one intervention seance
measure: Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention
timeFrame: 6 weeks
measure: Evolution of the consumption of psychotropic drugs before the start of the intervention
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes
Study officials:
References: