Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders

Not Applicable

• Conditions: Behavioral Disorder
• Interventions: Behavioral: TOVERTAFEL; Behavioral: USUAL activities

• Registration Number: NCT04421833
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-09-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-14
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group starting with TOVERTAFEL activities	TOVERTAFEL	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.
group ending with TOVERTAFEL activities	TOVERTAFEL	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.
group starting with TOVERTAFEL activities	USUAL activities	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.
group ending with TOVERTAFEL activities	USUAL activities	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.

Primary Outcome Measures

Name	Time	Method
Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention	6 weeks	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

Name	Time	Method
Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention	6 weeks	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	6 weeks	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.
Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale	before and after one intervention seance	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.

Trial Locations

Locations (1)

Hôpital des Charpennes; 🇫🇷 Villeurbanne, France