Effectiveness of Flash Mediation Therapy

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: 4 months control condition-2 months chariot flash; Behavioral: 2 months control condition - 4 months chariot-flash

• Registration Number: NCT02933177
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 months control condition-2 months chariot flash	4 months control condition-2 months chariot flash	200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition
2 months control condition - 4 months chariot-flash	2 months control condition - 4 months chariot-flash	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.

Primary Outcome Measures

Name	Time	Method
Change in number of disorders	until 4 months	the number of disorders are evaluated with Cohen Mansfield Agitation Inventory (CMAI) before and 30 minutes after each intervention.; The original version of the CMAI is initially planned to study the frequency of these disorders. However, the goal being to study the decrease in productive symptoms, after using the "chariot-flash", only the number of this item will be considered (between 0 and 29). For example in this modified version, for the item "pace, aimless wandering" nursing team can answer "present" or "absent" instead of (never, less than once a week, once or twice per week, a few times over week, one to two times daily, several times a day, several times per hour)

Secondary Outcome Measures

Name	Time	Method
Change in score of well-being	until 4 months	the score of well-being is assessed using the Instant Well-Being scale (Evaluation Instantané du Bien-Etre : EVIBE) before and 30 minutes after each intervention .; The EVIBE is a visual analogue scale for reporting the status of well-being of the patient at a specific time. On a graduated scale from 0 to 5, the caregiver should position a cursor position to the left corresponding to the feeling of well-being the lowest and the right position to the feeling of well-being the highest.
change in level of agitation	before the beginning of the study, at 2 months, 4 months and 6 months	the level of agitation is assessed using the original version of CMAI. The CMAI lists 29 agitation and aggressive behaviors by frequency (0: not evaluable 1: never, 2: less than once a week 3 : once or twice per week, 4 : a few times over week, 5: one to two times daily, 6 : several times a day, 7 : several times per hour) to obtain a score ranging from 0-203.
The number of hospitalization	at 2 months, 4 months and 6 months	The caregiver or doctor will refer in a table the different hospitalizations during the study and their date
The number of fall	at 2 months, 4 months and 6 months	The caregiver or doctor will refer in a table the different falls during the study and their date.
change in psychotropic drugs prescribed	until 4 months	The caregiver or doctor will check on a board what are the treatments that have been added or modified (compared to the usual treatment) in response to behavioral disorder
change in the number of administered psychotropic drugs.	before the beginning of the study, at 2 months, 4 months and 6 months	The caregiver or doctor will check on a board on which is written all psychotropic treatments that the patient takes and the dosage
change in score of BPSD	before the beginning of the study, at 2 months, 4 months and 6 months	the score of BPSD is assessed using the neuropsychiatric inventory nursing home version (NPI-NH).; Each of the 12 BPSD (delusions, hallucinations, agitation, depression, anxiety, excitement, apathy, disinhibition, depression, motor aberrant behavior, sleep and appetite) is evaluated on 12 depending on its frequency and severity (global score =144).

Trial Locations

Locations (1)

Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"; 🇫🇷 Lyon, France