UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the possibility of using AI speakers for care prevention and life support in elderly people living in depopulated areas
Acronym	Examination of the possibility of using AI speakers for care prevention and life support in elderly people living in depopulated areas
Scientific Title	Examination of the possibility of using AI speakers for care prevention and life support in elderly people living in depopulated areas
Scientific Title:Acronym	Examination of the possibility of using AI speakers for care prevention and life support in elderly people living in depopulated areas
Region	Japan

Condition
Condition	The possibility of using AI speakers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the possibility of using AI speakers in elderly people
Basic objectives2	Others
Basic objectives -Others	Clarify to what extent elderly people could use AI speakers.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We survey elderly people about how much they used and what they used (1 month, 3 months, and 6 months after using AI speakers).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Researchers installs an AI speaker in an elderly home and explains how to use it, and explain AI speaker's conversation function, schedule management function, and skills to introduce exercise and meal menus. Elderly people use AI speakers for 6 months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy elderly people
Key exclusion criteria	Elderly people with certificate for nursing care level 1-5, and who do not have a contract with an Internet service provider at home.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Atsuko Middle name Last name Taguchi
Organization	Tohoku University
Division name	Graduate School of Medicine
Zip code	980-8575
Address	2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
TEL	0227177922
Email	ataguchi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Atsuko Middle name Last name Taguchi
Organization	Tohoku University
Division name	Graduate School of Medicine
Zip code	980-8575
Address	2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
TEL	0227177922
Homepage URL
Email	ataguchi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Kirari Yoshijima network
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medicine, Tohoku University
Address	2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 11 Month 03 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 18 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 03 Day
Last modified on	2019 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043854