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Evaluation of the Animal Intervention Used as Therapy (ELIAUT)

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AAT and cognitive stimulation and rehabilitation of social tie.
Cognitive stimulation and rehabilitation of social tie.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease focused on measuring animal assisted therapy, well-being, Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hôpital des CharpennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

AAT arm

control group

Arm Description

AAT and cognitive stimulation and rehabilitation of social tie.

Cognitive stimulation and rehabilitation of social tie.

Outcomes

Primary Outcome Measures

evaluation of the changes of the well being from baseline until 3 months
Well-being will be assessed with a scale (EVIBE scale)

Secondary Outcome Measures

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)
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)
evaluation of the changes of the anxiety from baseline until 3 months
Anxiety will be measured by the State-Trait Anxiety Inventory (STAI)
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

Full Information

First Posted
July 4, 2016
Last Updated
August 8, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02829801
Brief Title
Evaluation of the Animal Intervention Used as Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
May 2, 2019 (Anticipated)
Study Completion Date
May 2, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
animal assisted therapy, well-being, Alzheimer's Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AAT arm
Arm Type
Experimental
Arm Description
AAT and cognitive stimulation and rehabilitation of social tie.
Arm Title
control group
Arm Type
Other
Arm Description
Cognitive stimulation and rehabilitation of social tie.
Intervention Type
Behavioral
Intervention Name(s)
AAT and cognitive stimulation and rehabilitation of social tie.
Intervention Description
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 ...).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive stimulation and rehabilitation of social tie.
Intervention Description
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.
Primary Outcome Measure Information:
Title
evaluation of the changes of the well being from baseline until 3 months
Description
Well-being will be assessed with a scale (EVIBE scale)
Time Frame
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 Measure Information:
Title
evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 months
Description
PBSD will be assessed by the Neuro Psychiatric Inventory, caregiver version (NPI)
Time Frame
before and immediately after care, and 1 month after the last session.
Title
evaluation of the changes of depressive symptoms from baseline until 3 months
Description
Depressive symptoms will be measured by the Geriatric Depression Scale 30 items (GDS 30)
Time Frame
before and immediately after care, and 1 month after the last session.
Title
evaluation of the changes of the anxiety from baseline until 3 months
Description
Anxiety will be measured by the State-Trait Anxiety Inventory (STAI)
Time Frame
before and immediately after care, and 1 month after the last session.
Title
evaluation of the changes of cognitive performances from baseline until 2 months
Description
The severity of cognitive impairment will be assessed by the Alzheimer's Disease Assessment Scale, cognitive part (ADAS-Cog), GRECO version
Time Frame
before et immediately after care.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Krolak-Salmon, PU-PH
Phone
4 72 43 20 50
Ext
+33
Email
pierre.krolak-salmon@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Solveig Relland
Phone
4 72 43 31 15
Ext
+33
Email
solveig.relland@chu-lyon.fr
Facility Information:
Facility Name
Hôpital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak-Salmon, PU-PH

12. IPD Sharing Statement

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Evaluation of the Animal Intervention Used as Therapy

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