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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030893
Receipt No. R000035275
Scientific Title Effect of communication robot "Hello Babies" on elderly care at nursing home
Date of disclosure of the study information 2018/01/20
Last modified on 2019/01/25

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Basic information
Public title Effect of communication robot "Hello Babies" on elderly care at nursing home
Acronym Effect of communication robot "Hello Babies" on elderly care at nursing home
Scientific Title Effect of communication robot "Hello Babies" on elderly care at nursing home
Scientific Title:Acronym Effect of communication robot "Hello Babies" on elderly care at nursing home
Region
Japan

Condition
Condition Elderly care
Classification by specialty
Geriatrics Psychiatry Rehabilitation medicine
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of communication robot "Hello Babies" on elderly care at nursing home
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Psychological response
Key secondary outcomes Change of Depressive state

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 communication robots for 4 weeks
Interventions/Control_2 normal doll
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
95 years-old >
Gender Male and Female
Key inclusion criteria Age between 65 and 95 ears old
Key exclusion criteria severe dementia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuko Obayashi
Organization Social Welfare Corporation Tokyo Seishinkai
Division name Flora Tanashi
Zip code
Address Mukodai 2-16-22 NishiTokyo, Tokyo Japan
TEL +81-42-468-2311
Email kakkoro114@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Masuyama
Organization Tokyo Medical University Hospital
Division name Travellers Medical Center
Zip code
Address 6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL +81-3-533903726
Homepage URL
Email s_masu@tokyo-med.ac.jp

Sponsor
Institute Social Welfare Corporation Tokyo Seishinkai
Institute
Department

Funding Source
Organization The Association for Technical Aid
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Universal Accessibility Evaluation Organization
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京聖新会(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2017 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2018 Year 01 Month 25 Day
Date of closure to data entry
2018 Year 02 Month 25 Day
Date trial data considered complete
2018 Year 03 Month 20 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 19 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035275

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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