UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050644 |
|---|---|
| Receipt number | R000057702 |
| Scientific Title | Randomized controlled trial to evaluate the effect of communication robots on the physical and psychological health of older adults |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/03/22 11:57:20 |
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Basic information
Public title
The effect of communication robots on the physical and psychological health of older adults
Acronym
The effect of communication robots on the physical and psychological health of older adults
Scientific Title
Randomized controlled trial to evaluate the effect of communication robots on the physical and psychological health of older adults
Scientific Title:Acronym
Randomized controlled trial to evaluate the effect of communication robots on the physical and psychological health of older adults
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the use of communication robot (BOCCO emo) on physical and psychological health of older adult.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Loneliness
Key secondary outcomes
Psychological health, depression, self-rated health, frequency of communicating with others, social trust, health competence
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The participants will use communication robot for a month after recruitment.
Interventions/Control_2
Control (no intervention)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Living alone
Key exclusion criteria
Those who are uncapable of using communication robots from reasons such as cognitive decline
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Kawamura |
Organization
SECOM Co., LTD.
Division name
SMART Project
Zip code
150-0001
Address
1-5-1 Jingu-mae, Shibuya-ku Tokyo, Japan .
TEL
03-5775-8760
yui-kawamura@secom.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Murayama |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
murayama@tmig.or.jp
Sponsor or person
Institute
SECOM Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
SECOM Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
murayama@tmig.or.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
対象者の自宅
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 23 | 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
| 2022 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 14 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057702
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
