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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: emotion status
Geriatric Depression Scale and Short Form Health Scale(GDS-15)
Behavioral: Animal-assisted Therapy
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
  • pet therapy
  • the doctor dog
Experimental: cognition status
Short Portable mental state questionnaire(SPMSQ)
Behavioral: Animal-assisted Therapy
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
  • pet therapy
  • the doctor dog
Experimental: feeling healthy
Brief Symptom Rating Scale(BSRS-5)
Behavioral: Animal-assisted Therapy
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
  • pet therapy
  • the doctor dog
Experimental: activities of daily living status
Barthel index scale
Behavioral: Animal-assisted Therapy
By the professor leader makes social interaction, and helping residents with rehabilitation through the Doctor dogs.
Other Names:
  • pet therapy
  • the doctor dog

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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