UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062365 |
|---|---|
| Receipt number | R000071371 |
| Scientific Title | Early detection, prevention, and evaluation of treatment, care processes, and outcomes regarding delirium using sensing devices in acute care hospitals. |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 15:09:47 |
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Basic information
Public title
Early detection, prevention, and evaluation of treatment, care processes, and outcomes regarding delirium using sensing devices in acute care hospitals.
Acronym
Early detection, prevention, and evaluation of treatment, care processes, and outcomes regarding delirium using sensing devices in acute care hospitals.
Scientific Title
Early detection, prevention, and evaluation of treatment, care processes, and outcomes regarding delirium using sensing devices in acute care hospitals.
Scientific Title:Acronym
Early detection, prevention, and evaluation of treatment, care processes, and outcomes regarding delirium using sensing devices in acute care hospitals.
Region
| Japan |
Condition
Condition
Individuals aged 20 or older at high risk of delirium
Classification by specialty
| Psychiatry | Neurosurgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct process and outcome evaluations regarding the use of sensing devices for the prevention, treatment, and care of delirium, based on the Consolidated Framework for Implementation Research.
Basic objectives2
Others
Basic objectives -Others
Acceptability, utility, and feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significance, benefits, perceived burden, and feasibility regarding the use of devices for delirium prevention, treatment, and care, as gathered through interviews and surveys.
Key secondary outcomes
Investigation of factors associated with the presence of delirium and sleep disorders and the risk of their onset.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In this study, we will implement early intervention care for delirium based on data obtained from sensing devices worn by hospitalized patients. Data collection will involve the use of sleep sensors and Fitbit devices, which patients will wear from the time consent is obtained until discharge. Terminals displaying visualized data from the sleep sensors will be installed for ward staff to utilize in providing early intervention care.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 20 or older at the time of registration who are at high risk of delirium
2.Individuals deemed suitable for the installation of sleep monitoring equipment and the wearing of a Fitbit, based on the judgment of a physician or nurse
3.Individuals admitted for an overnight stay or longer to the Department of Psychiatry/Neuropsychiatry, Department of Neurosurgery, or Department of Endovascular Neurosurgery
Key exclusion criteria
1.Individuals unable to use sleep monitoring devices or Fitbits due to suicide attempts or their medical condition
2.Individuals unable to use wearable devices due to skin irritation or similar issues
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Higami |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-8686
Address
7-6 Hatchonishimachi, Takatsuki City, Osaka Prefecture
TEL
072-683-1221
yoko.higami@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Higami |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-8686
Address
7-6 Hatchonishimachi, Takatsuki City, Osaka Prefecture
TEL
072-683-1221
Homepage URL
yoko.higami@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-cho, Takatsuki City, Osaka Prefecture
Tel
072-683-1221
rinri@ompu.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
| 2026 | Year | 07 | Month | 28 | 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
| 2026 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071371
