- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06722144
Animal-assisted Therapy Improves Cognitive and Emotion in Nursing Home Residents
December 4, 2024 updated by: Taipei Veterans General Hospital, Taiwan
More than 80% of the residents of the investigator's nursing home are dementia, who are often mentally and emotionally unstable.
The staff need to spend time helping to eliminate problems.
The investigator assume that non-drug intervention measures can be added, such as the Animal-assisted Therapy (AAT).
The hypothesis for ATT is expected to improve the mental and emotional inappropriate manifestations of dementia, reduce interfering behaviors, improve the quality of life, reduce the use of inappropriate mental drugs, and expect residents to delay the degradation of physiological functions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Nursing homes in the investigator's country accept dementia residents usually.
The dementia residents often suffer from mental and emotional problems.
Then they used drugs to improve the mental and emotional conditions.
There were many studies about non-drug treatments ,such as: gardening, nostalgia, pets, and other interventions were improved for the mental and emotional to dementia residents.Well-trained therapy dogs exhibit the behavior that human patients construe as friendly and welcoming.AAT dogs are also required to possess a calm temperament for accommodating the contact with unfamiliar clients while they serve as a source of comfort.
In domestic observational studies, non-pharmaceutical interventions for people with dementia who have activities and the hypothesis for ATT can improve the quality of care for dementia, reduce the use of mentally inappropriate drugs, and delay the degree of degeneration.
Recent evidence has shown that nursing institutions with dementia arranged weekly activities with AAT for a period of 6 months.
Significant improvement was in social interaction, emotional expression, and behavioral and psychological symptoms.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Residents of long-term care homes
- No fear or allergy to dogs
- Wheelchair accessible persons
- Able to communicate in Mandarin and Taiwanese
- Agree to sign the subject consent form
Exclusion Criteria:
- Non-residents of nursing homes
- Fear and allergy to dogs
- Bedridden and wheelchair users
- Do not agree to sign the subject consent form
Note: Although many nursing home residents have symptoms of dementia, many have not been diagnosed by a doctor, so dementia and other related diseases cannot be included in the inclusion or exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: emotion status
Geriatric Depression Scale and Short Form Health Scale(GDS-15)
|
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
|
|
Experimental: cognition status
Short Portable mental state questionnaire(SPMSQ)
|
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
|
|
Experimental: feeling healthy
Brief Symptom Rating Scale(BSRS-5)
|
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
|
|
Experimental: activities of daily living status
Barthel index scale
|
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Short Portable mental state questionnaire (SPMSQ)
Time Frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
This scale was adopted in this study to assess the participants' cognitive functions.
|
The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Geriatric Depression Scale (GDS-15)
Time Frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
The two scales were adopted in this study to assess the participants' depressive and the participants' emotion state
|
The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
|
The Barthel Index
Time Frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
This index was adopted in this study to assess the participants' physical mobility and function.
|
The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
|
The Brief Symptom Rating Scale(BSRS-5)
Time Frame: The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
The participants' feeling healthy
|
The experimental and control groups were subjected to a pre-test after they were recruited. There are 12 times AAT, once a week.The AAT did in experimental group,then both groups, there are three post-tests were taken 8th、12th and 16th weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Su-Jen Wang, Taipei Veterans General Hospital, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lai NM, Chang SMW, Ng SS, Tan SL, Chaiyakunapruk N, Stanaway F. Animal-assisted therapy for dementia. Cochrane Database Syst Rev. 2019 Nov 25;2019(11):CD013243. doi: 10.1002/14651858.CD013243.pub2.
- Chen H, Wang Y, Zhang M, Wang N, Li Y, Liu Y. Effects of animal-assisted therapy on patients with dementia: A systematic review and meta-analysis of randomized controlled trials. Psychiatry Res. 2022 Aug;314:114619. doi: 10.1016/j.psychres.2022.114619. Epub 2022 May 10.
Helpful Links
- Animal-Assisted Therapy used in psychiatric symptoms and dementia patinets.
- Functional Outcomes in a Randomized Controlled Trial of Animal-Assisted Therapy on Middle-Aged and Older Adults with Schizophrenia.
- Animal-assisted therapy for dementia
- Effects of animal-assisted therapy on patients with dementia: A systematic review and meta-analysis of randomized controlled trials
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2024
Primary Completion (Actual)
November 10, 2024
Study Completion (Actual)
November 20, 2024
Study Registration Dates
First Submitted
April 30, 2024
First Submitted That Met QC Criteria
December 4, 2024
First Posted (Estimated)
December 9, 2024
Study Record Updates
Last Update Posted (Estimated)
December 9, 2024
Last Update Submitted That Met QC Criteria
December 4, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2024-02-014C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We don't have a plan to make individual participant data (IPD) available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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