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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Loneliness focused on measuring geriatric psychiatry, chatbot, conversational agent

Eligibility Criteria

55 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 1, 2021
    Last Updated
    September 22, 2021
    Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    National Taipei University of Technology
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    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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