Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
Primary Purpose
Loneliness, Geriatric Depression
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
caring chatbot
Sponsored by
About this trial
This is an interventional other trial for Loneliness focused on measuring geriatric psychiatry, chatbot, conversational agent
Eligibility Criteria
Inclusion Criteria:
- with the diagnosis of persistent depressive disorder, major depressive disorder, general anxiety disorder, panic disorder, or agoraphobia
- the condition of their disease is relatively stable (defined as no thought of death and no medication adjustment in the recent 3 months).
- Have a personal mobile phone or communicator that can connect to the Internet
Exclusion Criteria:
- Those who are unwilling to participate in this research
- Those who have poor assessment ability by clinicians and cannot understand the content of the questionnaire; or those who cannot continue to complete the test due to their physical condition
- Comorbid schizophrenia or bipolar disorder
- Patients with dementia, brain injury, substance abuse, and stroke
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
caring chatbot
Arm Description
The investigators will enroll participants aged over 55 in the psychiatric outpatient department. The participants will get a one-month caring chatbot and can interact with the chatbot freely.
Outcomes
Primary Outcome Measures
acceptance measured by seven-point Likert scales
Satisfacation (How satisfied were you with Chatbot?), usability (How easy was talking to Chatbot?), continue (How much would you like to continue working with Chatbot?) and adherence (How likely is it that you will follow Chatbot's advice?) were measured by single items on seven-point Likert scales (with 1= "not at all" and 7="very much").
Secondary Outcome Measures
Change from baseline "loneliness" measured by UCLA Loneliness Scale
The UCLA Loneliness Scale (version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, and researchers later reverse-code the positively worded items so that high values mean more loneliness.
Change from baseline "depression" measured by Geriatric Depression Scale-Short Form (GDS-15)
Geriatric Depression Scale (GDS) is designed for the older population. A Short Form GDS consisting of 15 questions. Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest indicated depression when answered negatively. Scores of 5-8 indicate mild depression; 9-11 indicate moderate depression; 12-15 indicate severe depression.
Change from baseline "anxiety" measured by Hospital Anxiety and Depression Scale- Anxiety subscale
Hospital Anxiety and Depression Scale (HADS) is developed for people with physical illnesses. This scale includes a total of 14 questions. There are 7 questions about anxiety and depression, each with a 4-point scoring method (0-3 points). The higher the total score, the greater the anxiety or the greater the depression. Due to the high overlap between the topics of the depression subscale and the GDS, this study only uses the anxiety subscale.
Change from baseline "quality of life" measured by Short Form Quality Life Sale (SF-12)
Short Form Quality Life Sale (SF-12) is the most commonly used questionnaire in the study of the quality of life of the elderly, with a total score ranging from 13~43. A higher score reflects a better life quality.
Change from baseline "physical activity" measured by International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS)
International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS) measures the physical activity of the participant in the past seven days by self-filled method. The questionnaire is consisted of four domains: (1)during transportation, (2) at work, (3) during household and gardening tasks and (4) during leisure time, including exercise and sport participation. In each of the four domains the number of days per week and time per day spent in both moderate and vigorous activity are recorded.
Full Information
NCT ID
NCT05054660
First Posted
September 1, 2021
Last Updated
September 22, 2021
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Taipei University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT05054660
Brief Title
Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
Official Title
Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Taipei University of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will use the caring chatbot developed by the Taipei University of Technology team to provide care for participants and use robots to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the physical and mental health of the elderly.
Detailed Description
The prevalence of anxiety and depression in middle-aged and elderly people is quite high. Among the risk factors for illness, "loneliness" is closely related to the physical and mental health of the elderly: the higher the loneliness of the elderly, the more likely to develop unhealthy lifestyle habits and emotional symptoms such as depression and anxiety. Depression and anxiety are often comorbid, and the diagnoses of the two groups have many symptoms that overlap each other. Emotional symptoms that have not been effectively treated have a great impact on the quality of life, and the drug treatment of emotional disorders in the elderly is more difficult. In addition to medication, maintaining a healthy lifestyle is also conducive to the control of emotional disorders.
Information technology has been used in supplementary medical care and maintenance of physical and mental health for decades. However, reviewing the literature, there is less research on applications developed in cooperation between the information field and the field of psychiatric medical care, and there are no applications developed for the mental health of middle-aged and elderly people.
This study will use the caring chatbot developed by the National Taipei University of Technology team to provide care for the participants enrolled from the psychiatric outpatient department, and use the chatbot to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the mental health of the elderly.
This research anticipates the following goals:
With the chatbot developed, it provides care for subjects every day and collects their daily changes in mood, sleep, and activities.
Analyze the relationship between robot interaction and emotional changes, and evaluate the impact of chatbot intervention on the health behavior of the case.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loneliness, Geriatric Depression
Keywords
geriatric psychiatry, chatbot, conversational agent
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
psychiatry outpatient using the investigator-developed-chatbot, and evaluate effectiveness, acceptability, usability, and adoption
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
caring chatbot
Arm Type
Experimental
Arm Description
The investigators will enroll participants aged over 55 in the psychiatric outpatient department. The participants will get a one-month caring chatbot and can interact with the chatbot freely.
Intervention Type
Other
Intervention Name(s)
caring chatbot
Intervention Description
The investigators will use the developed caring chatbot to provide care to the cases and to collect case treatment data and interaction data between the case and the caring chatbot.
Primary Outcome Measure Information:
Title
acceptance measured by seven-point Likert scales
Description
Satisfacation (How satisfied were you with Chatbot?), usability (How easy was talking to Chatbot?), continue (How much would you like to continue working with Chatbot?) and adherence (How likely is it that you will follow Chatbot's advice?) were measured by single items on seven-point Likert scales (with 1= "not at all" and 7="very much").
Time Frame
at the end of one-month-intervention of the caring chatbot
Secondary Outcome Measure Information:
Title
Change from baseline "loneliness" measured by UCLA Loneliness Scale
Description
The UCLA Loneliness Scale (version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, and researchers later reverse-code the positively worded items so that high values mean more loneliness.
Time Frame
before and at the end of one-month-intervention of the caring chatbot
Title
Change from baseline "depression" measured by Geriatric Depression Scale-Short Form (GDS-15)
Description
Geriatric Depression Scale (GDS) is designed for the older population. A Short Form GDS consisting of 15 questions. Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest indicated depression when answered negatively. Scores of 5-8 indicate mild depression; 9-11 indicate moderate depression; 12-15 indicate severe depression.
Time Frame
before and at the end of one-month-intervention of the caring chatbot
Title
Change from baseline "anxiety" measured by Hospital Anxiety and Depression Scale- Anxiety subscale
Description
Hospital Anxiety and Depression Scale (HADS) is developed for people with physical illnesses. This scale includes a total of 14 questions. There are 7 questions about anxiety and depression, each with a 4-point scoring method (0-3 points). The higher the total score, the greater the anxiety or the greater the depression. Due to the high overlap between the topics of the depression subscale and the GDS, this study only uses the anxiety subscale.
Time Frame
before and at the end of one-month-intervention of the caring chatbot
Title
Change from baseline "quality of life" measured by Short Form Quality Life Sale (SF-12)
Description
Short Form Quality Life Sale (SF-12) is the most commonly used questionnaire in the study of the quality of life of the elderly, with a total score ranging from 13~43. A higher score reflects a better life quality.
Time Frame
before and at the end of one-month-intervention of the caring chatbot
Title
Change from baseline "physical activity" measured by International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS)
Description
International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS) measures the physical activity of the participant in the past seven days by self-filled method. The questionnaire is consisted of four domains: (1)during transportation, (2) at work, (3) during household and gardening tasks and (4) during leisure time, including exercise and sport participation. In each of the four domains the number of days per week and time per day spent in both moderate and vigorous activity are recorded.
Time Frame
before and at the end of one-month-intervention of the caring chatbot
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
with the diagnosis of persistent depressive disorder, major depressive disorder, general anxiety disorder, panic disorder, or agoraphobia
the condition of their disease is relatively stable (defined as no thought of death and no medication adjustment in the recent 3 months).
Have a personal mobile phone or communicator that can connect to the Internet
Exclusion Criteria:
Those who are unwilling to participate in this research
Those who have poor assessment ability by clinicians and cannot understand the content of the questionnaire; or those who cannot continue to complete the test due to their physical condition
Comorbid schizophrenia or bipolar disorder
Patients with dementia, brain injury, substance abuse, and stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Hsin Chou, MD
Phone
(03)3281288
Ext
2485
Email
b9302015@cgmh.org.tw
12. IPD Sharing Statement
Learn more about this trial
Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
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