UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050241 |
|---|---|
| Receipt number | R000057180 |
| Scientific Title | The evaluation of the usefulness of a wearable wireless nurse call device that detects a patient's fevers and undesirable movements, which then sends a Line message to a nurse and a physician in charge. |
| Date of disclosure of the study information | 2023/02/06 |
| Last modified on | 2023/02/06 14:14:49 |
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Basic information
Public title
The evaluation of the usefulness of a wearable wireless nurse call device that detects a patient's fevers and undesirable movements, which then sends a Line message to a nurse and a physician in charge.
Acronym
The evaluation of a wearable wireless device that informs a patient's status via Line.
Scientific Title
The evaluation of the usefulness of a wearable wireless nurse call device that detects a patient's fevers and undesirable movements, which then sends a Line message to a nurse and a physician in charge.
Scientific Title:Acronym
The evaluation of a wearable wireless device that informs a patient's status via Line.
Region
| Japan |
Condition
Condition
Fever,Trauma
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inform a patient's fever and undesirable movements to a nurse and doctor in charge immediately, which will make the prognosis better and reduce the complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Better prognosis and fewer complications.
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
To carry a test device
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
An inpatient who needs a 24-hour monitoring or a wireless nurse call
Key exclusion criteria
1. In case a patient or his/her legal guardian does not consent to participating in this study.
2. A patient who lives with a pacemaker or a defibrillator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Miyamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Neurosurgery
Zip code
4130012
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
TEL
0557-81-9171
smiyamoto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Miyamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Neurosurgery
Zip code
4130012
Address
International University of Health and Welfare Atami Hospital
TEL
0557819171
Homepage URL
smiyamoto@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
International University of Health and Welfare Atami Hospital
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
Tel
0557819171
smiyamoto@iuhw.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
| 2023 | Year | 02 | Month | 06 | 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
| 2023 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057180
