Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders

NCT ID: NCT04421833

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2021-08-31

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.

Conditions

Behavioral Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

group starting with TOVERTAFEL 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 Type: ACTIVE_COMPARATOR

TOVERTAFEL

Intervention Type: BEHAVIORAL

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.

USUAL activities

Intervention Type: BEHAVIORAL

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.

group ending with TOVERTAFEL 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.

Group Type: SHAM_COMPARATOR

TOVERTAFEL

Intervention Type: BEHAVIORAL

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.

USUAL activities

Intervention Type: BEHAVIORAL

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.

Interventions

TOVERTAFEL

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

USUAL activities

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 106 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital des Charpennes

Villeurbanne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Floriane Delphin-Combe

Role: CONTACT

floriane.delphin-combe@chu-lyon.fr

472433135 ext. +33

Sylvain Calvi

Role: CONTACT

sylvain.calvi@chu-lyon.fr

472433135 ext. +33

Facility Contacts

Floriane Delphin-Combe

Role: primary

floriane.delphin-combe@chu-lyon.fr

472433135 ext. +33

Other Identifiers

69HCL20_0145

Identifier Type: -

Identifier Source: org_study_id