Evaluation of the Animal Intervention Used as Therapy

Alzheimer Disease Clinical Trial

— ELIAUT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829801
• Other study ID #: 69HCL15_678
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2016
• Last updated: August 8, 2017
• Start date: March 2, 2016
• Est. completion date: May 2, 2019

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: Pierre Krolak-Salmon, PU-PH
• Phone: 4 72 43 20 50
• Email: pierre.krolak-salmon[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• AAT and cognitive stimulation and rehabilitation of social tie.
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 ...).
• Cognitive stimulation and rehabilitation of social tie.
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.

Locations

Country	Name	City	State
France	Hôpital des Charpennes	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.