UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033517
Receipt number 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 20:12:58

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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 or person

Institute

Chiba University

Institute

Department

Personal name



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

Value
https://center6.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