Alzheimer DiseaseELIAUTNCT02829801
Evaluation of the Animal Intervention Used as Therapy
A study testing AAT and cognitive stimulation and rehabilitation of social tie. and Cognitive stimulation and rehabilitation of social tie. in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AAT and cognitive stimulation and rehabilitation of social tie. and Cognitive stimulation and rehabilitation of social tie.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2016to 2 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital des Charpennes
Villeurbanne, 69100
Pierre Krolak-Salmon, PU-PH
About this study
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
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.
Read more
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
- Being tested
- AAT and cognitive stimulation and rehabilitation of social tie., Cognitive stimulation and rehabilitation of social tie.
- Keywords
- animal assisted therapy, well-being, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAT and cognitive stimulation and rehabilitation of social tie.Behavioural
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 ...).
Cognitive stimulation and rehabilitation of social tie.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AAT arm | Experimental | AAT and cognitive stimulation and rehabilitation of social tie. Receives: Behavioral: AAT and cognitive stimulation and rehabilitation of social tie. |
| control group | Other | Cognitive stimulation and rehabilitation of social tie. Receives: Behavioral: Cognitive stimulation and rehabilitation of social tie. |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the changes of the well being from baseline until 3 months
Well-being will be assessed with a scale (EVIBE scale)
Measured: 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
PBSD will be assessed by the Neuro Psychiatric Inventory, caregiver version (NPI)
Measured: before and immediately after care, and 1 month after the last session.
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)
Measured: before and immediately after care, and 1 month after the last session.
evaluation of the changes of the anxiety from baseline until 3 months
Anxiety will be measured by the State-Trait Anxiety Inventory (STAI)
Measured: before and immediately after care, and 1 month after the last session.
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
Measured: before et immediately after care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start2 Mar 2016
- Primary completion2 May 2019 (estimated)
- Study completion2 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829801
- Sponsor's protocol ID
- 69HCL15_678
- Acronym
- ELIAUT
- Status last verified
- Aug 2017
- First submitted
- 4 Jul 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02829801
- Acronym / sponsor ID
- ELIAUT / 69HCL15_678
- Conditions
- Alzheimer Disease
- Keywords
- animal assisted therapy, well-being, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 2 May 2019 (estimated)
- Study completion
- 2 May 2019 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAT arm | Experimental | Behavioral: AAT and cognitive stimulation and rehabilitation of social tie.AAT and cognitive stimulation and rehabilitation of social tie. |
| control group | Other | Behavioral: Cognitive stimulation and rehabilitation of social tie.Cognitive stimulation and rehabilitation of social tie. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ...). | Behavioural | AAT arm |
| 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. | Behavioural | control group |
Primary outcome
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)
4 secondary outcomes
evaluation of the changes of psycho-behavioral symptoms of dementia (PBSD) from baseline until 3 months
Time frame: before and immediately after care, and 1 month after the last session.
evaluation of the changes of depressive symptoms from baseline until 3 months
Time frame: before and immediately after care, and 1 month after the last session.
evaluation of the changes of the anxiety from baseline until 3 months
Time frame: before and immediately after care, and 1 month after the last session.
evaluation of the changes of cognitive performances from baseline until 2 months
Time frame: before et immediately after care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAT and cognitive stimulation and rehabilitation of social tie. and Cognitive stimulation and rehabilitation of social tie. in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Krolak-Salmon, PU-PH (4 72 43 20 50 ext. +33, pierre.krolak-salmon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.