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Clinical Trials/NCT02829801
NCT02829801
Unknown
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country40 target enrollmentMarch 2, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
1
Primary Endpoint
evaluation of the changes of the well being from baseline until 3 months
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2016
End Date
May 2, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

evaluation of the changes of the well being from baseline until 3 months

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

Well-being will be assessed with a scale (EVIBE scale)

Secondary Outcomes

  • 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 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 cognitive performances from baseline until 2 months(before et immediately after care.)

Study Sites (1)

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