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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037374
Receipt No. R000042519
Scientific Title Effectiveness of a communication robot by cluster randomized controlled trial
Date of disclosure of the study information 2019/07/20
Last modified on 2020/08/25

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Basic information
Public title Effectiveness of a communication robot by cluster randomized controlled trial
Acronym Effectiveness of a communication robot by cluster randomized controlled trial
Scientific Title Effectiveness of a communication robot by cluster randomized controlled trial
Scientific Title:Acronym Effectiveness of a communication robot by cluster randomized controlled trial
Region
Japan

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

Objectives
Narrative objectives1 To clarify the difference between two groups of elderly people with dementia when PARO is applied at different frequencies.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NPI-Q(Neuropsychiatric Inventory Questionnaire) for elderly people with dementia
Before and after one month intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Applying a robot for an hour per a day. Caregivers place a robot on a table in a shared space, invite subjects there and let them enjoy a robot. this froup is provided a robot once a week.
Interventions/Control_2 Applying a robot for an hour per a day. Caregivers place a robot on a table in a shared space, invite subjects there and let them enjoy a robot. this froup is provided a robot three times a week.
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 Elderly people with dementia who live in shared homes.
Key exclusion criteria persons with skin infections, persons who dislike a robot
Target sample size 150

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 0338191211
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 +81338191211
Homepage URL
Email inoue@tmu.ac.jp

Sponsor
Institute Tokyo Metropolitan University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Arakawa Campus
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo
Tel 0338191211
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
2019 Year 07 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 10 Day
Date of IRB
2018 Year 06 Month 20 Day
Anticipated trial start date
2019 Year 02 Month 15 Day
Last follow-up date
2020 Year 03 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 07 Month 14 Day
Last modified on
2020 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042519

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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