Evaluation of the Animal Intervention Used as Therapy (ELIAUT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: AAT and cognitive stimulation and rehabilitation of social tie.; Behavioral: Cognitive stimulation and rehabilitation of social tie.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Krolak-Salmon, PU-PH; Phone Number: +33 4 72 43 20 50; Email: pierre.krolak-salmon@chu-lyon.fr
• Study Contact Backup: Name: Solveig Relland; Phone Number: +33 4 72 43 31 15; Email: solveig.relland@chu-lyon.fr

Study Locations

• France
  • Villeurbanne, France, 69100
    • Recruiting
    • Hôpital des charpennes
    • Principal Investigator: Pierre Krolak-Salmon, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AAT arm; AAT and cognitive stimulation and rehabilitation of social tie.	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 ...).
OTHER: control group; Cognitive stimulation and rehabilitation of social tie.	Behavioral: 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2016
• Primary Completion (ANTICIPATED): May 2, 2019
• Study Completion (ANTICIPATED): May 2, 2019

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (ESTIMATE): July 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; well-being; animal assisted therapy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 69HCL15_678