Evaluation of the Animal Intervention Used as Therapy
ELIAUT
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Mar 2016
Typical duration for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2016
CompletedFirst Submitted
Initial submission to the registry
July 4, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2019
CompletedAugust 9, 2017
August 1, 2017
3.2 years
July 4, 2016
August 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 months
before and immediately after care, and 1 month after the last session.
evaluation of the changes of depressive symptoms from baseline until 3 months
before and immediately after care, and 1 month after the last session.
evaluation of the changes of the anxiety from baseline until 3 months
before and immediately after care, and 1 month after the last session.
evaluation of the changes of cognitive performances from baseline until 2 months
before et immediately after care.
Study Arms (2)
AAT arm
EXPERIMENTALAAT and cognitive stimulation and rehabilitation of social tie.
control group
OTHERCognitive stimulation and rehabilitation of social tie.
Interventions
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 ...).
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital des Charpennes
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2016
First Posted
July 12, 2016
Study Start
March 2, 2016
Primary Completion
May 2, 2019
Study Completion
May 2, 2019
Last Updated
August 9, 2017
Record last verified: 2017-08