Clinical trial NCT02933177: Effectiveness of Flash Mediation Therapy
Official title: Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Alzheimer disease
Behavioral and Psychological Symptoms of Dementia
non-drug intervention
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 241
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in number of disorders
timeFrame: until 4 months
Secondary outcomes:
measure: Change in score of well-being
timeFrame: until 4 months
measure: change in psychotropic drugs prescribed
timeFrame: until 4 months
measure: change in score of BPSD
timeFrame: before the beginning of the study, at 2 months, 4 months and 6 months
measure: change in level of agitation
timeFrame: before the beginning of the study, at 2 months, 4 months and 6 months
measure: change in the number of administered psychotropic drugs.
timeFrame: before the beginning of the study, at 2 months, 4 months and 6 months
measure: The number of hospitalization
timeFrame: at 2 months, 4 months and 6 months
measure: The number of fall
timeFrame: at 2 months, 4 months and 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre Krolak Salmon
role: PRINCIPAL_INVESTIGATOR
References: