Evaluation of the Animal Intervention Used as Therapy. Impact of Animal-assisted Therapy on the Well-being in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- evaluation of the changes of the well being from baseline until 3 months
研究概览
简要总结
The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in geriatrics. Many studies have shown a link between the presence of the animal and the psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or irritability that affects their quality of life and improved cognitive abilities. However, many methodological flaws in these researches exist.
The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short and medium term (before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session) compared to a group receiving the same stimulation without the dog's response.
Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: AAT group versus control group. The only difference between these two groups is the intervention of the dog at each workshop in the AAT group.
Each workshop will consist of three identical times. It will begin with a 15 minute introductory activity, the first goal will be to establish a relationship with patients (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the session This study should highlight a positive effect of animal assisted therapy on the well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of these positive effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled patients should have been informed and should not oppose the research, by themselves or through a trusted person, failing this, by the family, or, by a close person maintain stable ties; Subject aged over 65 years fulfilling the criteria of Alzheimer's disease the major NCD stage with or without vascular disorders; Ambulatory patient in Charpennes Day Hospital ; Being affiliated to health insurance.
排除标准
- •Patients with signs and symptoms suggestive of dementia related to other diseases than AD or mixed forms ; Patients with progressive and unstable pathologies which could interfere with the variables under consideration ; Deafness or blindness which could compromise the evaluation of the patient or his involvement during the sessions ; Patient being under guardianship ; Patient refusing the work with a animal ; Patient allergic to dogs ; Patient ending his care prior to the 13 weeks required for the study. Exclusion criteria will be sought during the questioning of the patient and his relatives as well as the review of his medical file (organic and neuroradiological explorations).
研究组 & 干预措施
control group
Cognitive stimulation and rehabilitation of social tie.
干预措施: Cognitive stimulation and rehabilitation of social tie. (Behavioral)
AAT arm
AAT and cognitive stimulation and rehabilitation of social tie.
干预措施: AAT and cognitive stimulation and rehabilitation of social tie. (Behavioral)
结局指标
主要结局
evaluation of the changes of the well being from baseline until 3 months
时间窗: before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session
Well-being will be assessed with a scale (EVIBE scale)
次要结局
- evaluation of the changes of the anxiety from baseline until 3 months(before and immediately after care, and 1 month after the last session.)
- evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 months(before and immediately after care, and 1 month after the last session.)
- evaluation of the changes of depressive symptoms from baseline until 3 months(before and immediately after care, and 1 month after the last session.)
- evaluation of the changes of cognitive performances from baseline until 2 months(before et immediately after care.)