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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05054660
Other study ID # 202001915B0C601
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 27, 2021
Est. completion date July 31, 2022

Study information

Verified date August 2021
Source Chang Gung Memorial Hospital
Contact Ya-Hsin Chou, MD
Phone (03)3281288
Email b9302015@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. With the chatbot developed, it provides care for subjects every day and collects their daily changes in mood, sleep, and activities. 2. Analyze the relationship between robot interaction and emotional changes, and evaluate the impact of chatbot intervention on the health behavior of the case.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date July 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years to 110 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
caring chatbot
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital National Taipei University of Technology

Outcome

Type Measure Description Time frame Safety issue
Primary 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"). at the end of one-month-intervention of the caring chatbot
Secondary 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. before and at the end of one-month-intervention of the caring chatbot
Secondary 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. before and at the end of one-month-intervention of the caring chatbot
Secondary 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. before and at the end of one-month-intervention of the caring chatbot
Secondary 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. before and at the end of one-month-intervention of the caring chatbot
Secondary 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. before and at the end of one-month-intervention of the caring chatbot
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