NCT05054660

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 23, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

September 1, 2021

Last Update Submit

September 22, 2021

Conditions

Keywords

geriatric psychiatrychatbotconversational agent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change from baseline "loneliness" measured by UCLA Loneliness Scale

    before and at the end of one-month-intervention of the caring chatbot

  • Change from baseline "depression" measured by Geriatric Depression Scale-Short Form (GDS-15)

    before and at the end of one-month-intervention of the caring chatbot

  • Change from baseline "anxiety" measured by Hospital Anxiety and Depression Scale- Anxiety subscale

    before and at the end of one-month-intervention of the caring chatbot

  • Change from baseline "quality of life" measured by Short Form Quality Life Sale (SF-12)

    before and at the end of one-month-intervention of the caring chatbot

  • Change from baseline "physical activity" measured by International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS)

    before and at the end of one-month-intervention of the caring chatbot

Study Arms (1)

caring chatbot

EXPERIMENTAL

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.

Other: caring chatbot

Interventions

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.

caring chatbot

Eligibility Criteria

Age55 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ya-Hsin Chou, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: psychiatry outpatient using the investigator-developed-chatbot, and evaluate effectiveness, acceptability, usability, and adoption
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 23, 2021

Study Start

September 27, 2021

Primary Completion

January 31, 2022

Study Completion

July 31, 2022

Last Updated

September 23, 2021

Record last verified: 2021-08