UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056189 |
|---|---|
| Receipt number | R000064210 |
| Scientific Title | Verification of the usefulness of a new bed-integrated sensor to detect patients leaving their beds for the healthy adults and patients in Comprehensive Rehabilitation Ward |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2024/11/19 11:18:36 |
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Basic information
Public title
Verification of the usefulness of a new bed-integrated sensor to detect patients leaving their beds for the healthy adults and patients in Comprehensive Rehabilitation Ward
Acronym
Verification of the usefulness of a new bed-integrated sensor to detect patients leaving their beds for the healthy adults and patients in Comprehensive Rehabilitation Ward
Scientific Title
Verification of the usefulness of a new bed-integrated sensor to detect patients leaving their beds for the healthy adults and patients in Comprehensive Rehabilitation Ward
Scientific Title:Acronym
Verification of the usefulness of a new bed-integrated sensor to detect patients leaving their beds for the healthy adults and patients in Comprehensive Rehabilitation Ward
Region
| Japan |
Condition
Condition
Healthy adult
Patients admitted to a Comprehensive Rehabilitation Ward
Nursing staff who are part of a comprehensive rehabilitation ward
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Verify of the accuracy and usefulness of a new bed-integrated sensor to detect patients leaving their beds
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic information
(Age, gender, primary disease, medical history, etc)
Motion of sit up, stand up, sitting
The result of sensor
The result of survey(QUEST, SUS)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Consent to participate in this study
2.Participants whose general condition is stable
3.Participants who are able to sit up and stand by themselves in bed
Key exclusion criteria
A.Healthy adult and nursing care stuff
1.Participants who have difficulty understanding instructions
2.Participants who are judged to be inappropriate by the researche
B.Patient admitted to a Comprehensive Rehabilitation Ward
1.Participants who have difficulty understanding instructions
2.Participants who are not able to sit up and stand up by themselvies in bed
3.Participants who are judged to be inappropriate by the researcher
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
cent-rsh@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
cent-rsh@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2024 | Year | 11 | Month | 19 | 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
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To Verify of the accuracy and usefulness of a new bed-integrated sensor to detect patients leaving their beds
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064210
