UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036341 |
|---|---|
| Receipt number | R000041039 |
| Scientific Title | Development of a communication robot system realizing prevention of severe frailty of elderly living alone |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/04/22 10:20:03 |
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Basic information
Public title
Development of a communication robot system realizing prevention of severe frailty of elderly living alone
Acronym
The effect of a communication robot on prevention of severe frailty
Scientific Title
Development of a communication robot system realizing prevention of severe frailty of elderly living alone
Scientific Title:Acronym
The effect of a communication robot on prevention of severe frailty
Region
| Japan |
Condition
Condition
Frail or pre-Frail elderly
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims the verification of effect of a communication robot on prevention of severe frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of total scores of Kihon Checklist from baseline to one year after using a communication robot
Key secondary outcomes
Change of total scores of Social Frailty Scale, J-CHS(Japan Cardiovascular Health Study), MMSE(Mini-Mental State Examination), GDS-15(Geriatric depression scale 15), Apathy Scale and UCLA Loneliness Scale(Version 3) from baseline to one year after using a communication robot
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Communicate with family and respond to communication robot conversation everyday through communication robot at home for one year.
Interventions/Control_2
No Interventions
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) subjects who live at home alone, with their spouses, or alone while household members are at work
(2) subjects with frailty or pre-frailty (1 or more points in J-CHS, 1 or more points in FRAIL scale, or 4 or more points in Kihon checklist)
(3) subjects with social frailty or social pre-frailty (1 or more points in social frailty scale)
(4) subjects who can use a tablet device
(5) subjects who can participate in a frailty check-up as scheduled
(6) subjects who provide written informed consent before participation
Key exclusion criteria
(1) subjects who are employed
(2) subjects who are living in an facility for elderly
(3) subjects who don't understand the explanation of study
(4) subjects who can use e-mail/SNS with smart devices/PC
(5) subjects who already use similar communication robots
(6) subjects with 10 or more points in GDS-15
(7) subjects with 10 or less points in MMSE
(8) subjects who have already participated in other clinical trials
(9) subjects who are not permitted to participate by medical doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hamada |
Organization
NEC Corporation
Division name
Cross-Industry Unit
Zip code
108-8001
Address
5-7-1 Shiba, Minato-ku, Tokyo, Japan
TEL
03-3454-1111
elder-contact@fccp.jp.nec.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Fukushi |
Organization
NEC Corporation
Division name
Cross-Industry Unit
Zip code
108-8001
Address
5-7-1 Shiba, Minato-ku, Tokyo, Japan
TEL
03-3454-1111
Homepage URL
elder-contact@fccp.jp.nec.com
Sponsor or person
Institute
NEC Corporation
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development
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
NEC Ethical Review Committee for the Life Sciences
Address
5-7-1 Shiba, Minato-ku, Tokyo, Japan
Tel
03-3798-9520
rinri-shinsa@quality.jp.nec.com
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 | 04 | Month | 01 | 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
27
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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 26 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 26 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041039
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