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Evaluation of the Animal Intervention Used as Therapy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02829801
Acronym
ELIAUT
Enrollment
40
Registered
2016-07-12
Start date
2016-03-02
Completion date
2019-05-02
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

animal assisted therapy, well-being, Alzheimer's Disease

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.

Interventions

BEHAVIORALAAT 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 ...).

BEHAVIORALCognitive 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
evaluation of the changes of the well being from baseline until 3 monthsbefore care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last sessionWell-being will be assessed with a scale (EVIBE scale)

Secondary

MeasureTime frameDescription
evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 monthsbefore and immediately after care, and 1 month after the last session.PBSD will be assessed by the Neuro Psychiatric Inventory, caregiver version (NPI)
evaluation of the changes of depressive symptoms from baseline until 3 monthsbefore and immediately after care, and 1 month after the last session.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 monthsbefore and immediately after care, and 1 month after the last session.Anxiety will be measured by the State-Trait Anxiety Inventory (STAI)
evaluation of the changes of cognitive performances from baseline until 2 monthsbefore et immediately after care.The severity of cognitive impairment will be assessed by the Alzheimer's Disease Assessment Scale, cognitive part (ADAS-Cog), GRECO version

Countries

France

Contacts

Primary ContactPierre Krolak-Salmon, PU-PH
pierre.krolak-salmon@chu-lyon.fr4 72 43 20 50
Backup ContactSolveig Relland
solveig.relland@chu-lyon.fr4 72 43 31 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026