Effectiveness of Flash Mediation Therapy

Civil Hospices of Lyon

Status: Completed

Conditions: Dementia

Treatments: Behavioral: 2 months control condition - 4 months chariot-flash; Behavioral: 4 months control condition-2 months chariot flash

Study type: Interventional

Funder types: Other

Identifiers

NCT02933177

69HCL16_0442

Details and patient eligibility

About

In order to offer a non-drug intervention for caregivers in nursing home to respond promptly to a behavioral crisis with an appropriate response to each patient, a chariot has been developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring together eleven mediation activities. These activities lasting about 15 minutes are based on emotion (reminiscent, games) and sensory interventions (music, massage, touch) to decentralize patient stimulus that disturbs and focus on a subject not disruptive. This emergency intervention should provide a reduction in Behavioral and Psychological Symptom of Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The secondary objectives are to measure its immediate impact on the well-being and psychotropic treatments, and measure its effect after two months and after four months on all BPSD with a focus on agitation, the administration of psychotropic drugs, the hospitalizations and the number of falls.

Enrollment: 241 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People ability to object and does not oppose either by themselves or through a trusted person referred to in Article L. 1111-6 of the Code of Public Health, failing thereof, by the family, or, if a person talking to the person close and stable ties. For adults under guardianship, permission must be given by the legal representative of the person. The research will benefit from the backing of Persons Protection Committee (PPC) prior to its implementation;
• Man or woman over 60 years;
• patient living in one of the nursing homes participating in the project;
• Patient completing the diagnostic criteria for major neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders V criteria (DSM-V)
• The patient must have at least one of these productive symptoms (agitation, aberrant motor behavior, disinhibition) listed by the NPI-NH (score> 2 at least one of these items)

Exclusion criteria

• Deafness or blindness may compromise patient assessment or participation in the intervention

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

2 months control condition - 4 months chariot-flash

Experimental group

Description:

200 patient , in 15 nursing homes randomly will be exposed two months in the control condition (usual intervention) and 4 months in the experimental condition (chariot-flash intervention). The experimental condition is to propose the "chariot-flash" in emergency during the emergence or increase of productive symptoms.

Treatment:

Behavioral: 2 months control condition - 4 months chariot-flash

4 months control condition-2 months chariot flash

Experimental group

Description:

200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition

Treatment:

Behavioral: 4 months control condition-2 months chariot flash