UMIN-CTR Clinical Trial

Basic information
Public title	The effects of communication robot activity for elderly persons with dementia
Acronym	The effects of communication robot activity for elderly persons with dementia
Scientific Title	The effects of communication robot activity for elderly persons with dementia
Scientific Title:Acronym	The effects of communication robot activity for elderly persons with dementia
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to analyze when a communication robot is used by family members living at home with an elderly person with dementia, the effectiveness of care by family members that can be expected and to identify the priorities of problems to be solved from the results.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Profiles of elderly people, observation results of elderly people, results of interviews with family members
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Robot activity to the elderly by their family 3 times or more per week
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Elderly people with dementia living at home, Families living with them can handle a robot.
Key exclusion criteria	the elderly who refuse the robot
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kaoru Middle name Last name Inoue
Organization	Tokyo Metropolitan University
Division name	Faculty of Health Sciences
Zip code	1168551
Address	7-2-10,Higashiogu, Arakawa-ku, Tokyo
TEL	03-3819-1211
Email	inoue@tmu.ac.jp

Public contact
Name of contact person	1st name Kaoru Middle name Last name Inoue
Organization	Tokyo Metropolitan University
Division name	Faculty of Health Sciences
Zip code	1168551
Address	7-2-10,Higashiogu, Arakawa-ku, Tokyo
TEL	03-3819-1211
Homepage URL
Email	inoue@tmu.ac.jp

Sponsor
Institute	Tokyo Metropolitan University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Metropolitan University
Address	7-2-10, Higashiogu, Arakawa-ku, Tokyo
Tel	03-3819-1211
Email	inoue@tmu.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	2020 Year 02 Month 20 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	100
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The paper is being submitted to the journal
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	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Date of IRB	2014 Year 11 Month 28 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 13 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045008