Evaluation of the Animal Intervention Used as Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Animal Intervention Used as Therapy. Impact of Animal-assisted Therapy on the Well-being in Patients With Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: AAT and cognitive stimulation and rehabilitation of social tie.
* Behavioral: Cognitive stimulation and rehabilitation of social tie.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AAT arm<br>AAT and cognitive stimulation and rehabilitation of social tie. | Behavioral: AAT and cognitive stimulation and rehabilitation of social tie.<br>* There are 8 workshops, one workshop per week. The workshops will begin with a 15 minute introductory activity allowing the establishment of the relationship with the dog and between the participants. Activities with the dog will be offered: games, caresses, brushing. Then, a 40 minute cognitive stimulation will be offered. Finally, 5 minutes will be devoted to the closing of the session and to say goodbye to participants and the dog (pet him, play with him ...).<br>|
| Other: control group<br>Cognitive stimulation and rehabilitation of social tie. | Behavioral: Cognitive stimulation and rehabilitation of social tie.<br>* There are 8 workshops, one workshop per week. The workshops will begin with an introductory activity of 15 minutes that will establish the relationship between the participants. Different topics will be proposed to foster communication and exchange. Then, the same cognitive stimulation in the AAT arm will be offered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the changes of the well being from baseline until 3 months | Well-being will be assessed with a scale (EVIBE scale) | before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 months | PBSD will be assessed by the Neuro Psychiatric Inventory, caregiver version (NPI) | before and immediately after care, and 1 month after the last session. | 
| evaluation of the changes of depressive symptoms from baseline until 3 months | Depressive symptoms will be measured by the Geriatric Depression Scale 30 items (GDS 30) | before and immediately after care, and 1 month after the last session. | 
| evaluation of the changes of the anxiety from baseline until 3 months | Anxiety will be measured by the State-Trait Anxiety Inventory (STAI) | before and immediately after care, and 1 month after the last session. | 
| evaluation of the changes of cognitive performances from baseline until 2 months | The severity of cognitive impairment will be assessed by the Alzheimer's Disease Assessment Scale, cognitive part (ADAS-Cog), GRECO version | before et immediately after care. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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animal assisted therapy, well-being, Alzheimer's Disease