Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Change in number of disorders
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Deafness or blindness may compromise patient assessment or participation in the intervention
结局指标
主要结局
Change in number of disorders
时间窗: 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)
次要结局
- Change in score of well-being(until 4 months)
- change in level of agitation(before the beginning of the study, at 2 months, 4 months and 6 months)
- The number of hospitalization(at 2 months, 4 months and 6 months)
- The number of fall(at 2 months, 4 months and 6 months)
- change in psychotropic drugs prescribed(until 4 months)
- change in the number of administered psychotropic drugs.(before the beginning of the study, at 2 months, 4 months and 6 months)
- change in score of BPSD(before the beginning of the study, at 2 months, 4 months and 6 months)