Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders (TOVERTAFEL)

July 12, 2021 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Villeurbanne, France, 69100
        • Recruiting
        • Hôpital des Charpennes
        • Principal Investigator:
          • Pierre KROLAK-SALMON, Pr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 104 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.

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.

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.
Sham Comparator: 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.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention
Time Frame: 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale
Time Frame: 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.
before and after one intervention seance
Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention
Time Frame: 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.
6 weeks
Evolution of the consumption of psychotropic drugs before the start of the intervention
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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