Evaluation of the Animal Intervention Used as Therapy

NCT ID: NCT02829801

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2019-05-02

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

AAT arm

AAT and cognitive stimulation and rehabilitation of social tie.

Group Type: EXPERIMENTAL

AAT and cognitive stimulation and rehabilitation of social tie.

Intervention Type: BEHAVIORAL

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 ...).

control group

Cognitive stimulation and rehabilitation of social tie.

Group Type: OTHER

Cognitive stimulation and rehabilitation of social tie.

Intervention Type: BEHAVIORAL

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.

Interventions

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 ...).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital des Charpennes

Villeurbanne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre Krolak-Salmon, PU-PH

Role: CONTACT

pierre.krolak-salmon@chu-lyon.fr

4 72 43 20 50 ext. +33

Solveig Relland

Role: CONTACT

solveig.relland@chu-lyon.fr

4 72 43 31 15 ext. +33

Other Identifiers

69HCL15_678

Identifier Type: -

Identifier Source: org_study_id