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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033517
Receipt No. R000038031
Scientific Title Examining the Utilization of Home-Care Robots to Improve Assessment and Care of Older Persons in Home Care Support
Date of disclosure of the study information 2018/07/26
Last modified on 2019/08/30

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Basic information
Public title Examining the Utilization of Home-Care Robots to Improve Assessment and Care of Older Persons in Home Care Support
Acronym Examining the Utilization of Home-Care Robots to Improve Assessment and Care of Older Persons in Home Care Support
Scientific Title Examining the Utilization of Home-Care Robots to Improve Assessment and Care of Older Persons in Home Care Support
Scientific Title:Acronym Examining the Utilization of Home-Care Robots to Improve Assessment and Care of Older Persons in Home Care Support
Region
Japan

Condition
Condition dementia
Classification by specialty
Neurology Psychiatry Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the impact of introducing home-care robots on improving care and understanding of older persons with dementia in home-care support services
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in how care professionals understand older persons after the introduction of home-care robots
Key secondary outcomes 1) A questionnaire and open remarks on the stress level of care professionals (visual analog scale; prior to use of the home-care robot, 4 wk. after use, and 8 wk. after use)
2) Neuropsychiatric Inventory (Japanese version; prior to use of the home-care robot, 4 wk. after use, and 8 wk. after use)
3) Activities and participation form (evaluation form created using ICF detailed classifications and definitions; once every 4 wk.)
4) Monitoring information on older persons through home-care robots
5) Individual care plan
6) Content shared in group interviews (once every 4 wk.)

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 Prevention
Type of intervention
Other
Interventions/Control_1 A home-care robot is placed in the participant's room for 8 weeks. In addition, a silhouette sensor placed in the room and bed sensor placed in the bed are connected to the robot to collect data.
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 1) Participant (1)
1. An older person diagnosed with dementia
2. An older person capable of verbal communication
3. An older person capable of recognizing a robot as a robot
4. An older person judged by a facility manager as having an established daily rhythm and not easily physically or mentally influenced by participation in the study
5. An older person who has been admitted for at least 6 months
2) Participant (2)
1. A care professional caring for Participant (1)
2. A care manager supporting Participant (1)
Key exclusion criteria Regarding Participant (1), an older person capable of recovering through treatment for normal pressure hydrocephalus, chronic subdural hematoma, etc.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Sayuri
Middle name
Last name Suwa
Organization Chiba University Graduate School of Nursing
Division name Division of Visiting Nursing
Zip code 260-8672
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN
TEL 043-226-2446
Email suwa-sayuri@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Shunsuke
Middle name
Last name Shigemitsu
Organization Chiba University Graduate School of Nursing
Division name Division of Visiting Nursing, Master's Program
Zip code 260-8672
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN
TEL 043-226-2446
Homepage URL
Email s.shige@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical Review Board of the Graduate School of Nursing, School of Nursing, Chiba University
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN
Tel 043-226-2380
Email kango-rinri@chiba-u.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
2018 Year 07 Month 26 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 2
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
2018 Year 04 Month 24 Day
Date of IRB
2018 Year 04 Month 24 Day
Anticipated trial start date
2018 Year 07 Month 26 Day
Last follow-up date
2018 Year 12 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 25 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038031

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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