Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders

Civil Hospices of Lyon

Status: Unknown

Conditions: Behavioral Disorder

Treatments: Behavioral: USUAL activities; Behavioral: TOVERTAFEL

Study type: Interventional

Funder types: Other

Identifiers

NCT04421833

69HCL20_0145

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 60 to 106 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

group starting with TOVERTAFEL activities

Active Comparator group

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.

Treatment:

Behavioral: USUAL activities

Behavioral: TOVERTAFEL

group ending with TOVERTAFEL activities

Sham Comparator group

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.

Treatment:

Behavioral: USUAL activities

Behavioral: TOVERTAFEL