Clinical trial NCT02829801: Evaluation of the Animal Intervention Used as Therapy
Official title: Evaluation of the Animal Intervention Used as Therapy. Impact of Animal-assisted Therapy on the Well-being in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: animal assisted therapy
well-being
Alzheimer's Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: evaluation of the changes of the well being from baseline until 3 months
timeFrame: 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 outcomes:
measure: evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 months
timeFrame: before and immediately after care, and 1 month after the last session.
measure: evaluation of the changes of depressive symptoms from baseline until 3 months
timeFrame: before and immediately after care, and 1 month after the last session.
measure: evaluation of the changes of the anxiety from baseline until 3 months
timeFrame: before and immediately after care, and 1 month after the last session.
measure: evaluation of the changes of cognitive performances from baseline until 2 months
timeFrame: before et immediately after care.
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes
Study officials:
References: