UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062685 |
|---|---|
| Receipt number | R000071765 |
| Scientific Title | Development of an ICT-Based Remote Health Management Model for Older Adults Living at Home and in Care Facilities |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/25 18:32:03 |
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Basic information
Public title
Study of ICT-Based Remote Health Management for Older Adults
Acronym
Study of ICT-Based Remote Health Management for Older Adults
Scientific Title
Development of an ICT-Based Remote Health Management Model for Older Adults Living at Home and in Care Facilities
Scientific Title:Acronym
Study of ICT-Based Remote Health Management for Older Adults
Region
| Japan |
Condition
Condition
Older adults (no specific disease)
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a remote health management model for older adults that combines remote monitoring of heart rate, respiratory rate, and sleep status using the ICT device Nemuri SCAN Paramount Bed Co., Ltd.with physical assessment by nurses when changes in health status are suspected. The model is intended to facilitate early identification of changes in health status and, when necessary, consultation with healthcare professionals or referral for medical care. In addition, through implementation of the model, this study will exploratorily evaluate issues related to the introduction and use of the device, nurses experiences with its use, and its perceived usefulness, and will examine the feasibility of implementing the model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of changes in participants' health status identified after initiation of remote monitoring using Nemuri SCAN
Key secondary outcomes
Symptoms and complaints, physical assessment findings, and information obtained from family members or others when changes in health status are identified
Nurses' clinical decision-making and responses, including the basis for their decisions, assessment of urgency and need for intervention, consultation with physicians, actions taken, and time required for response
Medical consultations, ambulance transportation, hospitalization, and subsequent outcomes, as well as conditions required for continued implementation of the model and areas for improvement
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
| Other |
Interventions/Control_1
Remote monitoring using Nemuri SCAN
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
| 64 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals living at home or in care facilities who receive services from a collaborating research institution and who are considered by participating nurses to be appropriate candidates for remote monitoring based on at least one of the following criteria:
Individuals who are at high risk of changes in health status shortly after hospital discharge;
Individuals in whom an acute change in health status is suspected but who do not require immediate ambulance transportation; or
Individuals for whom participating nurses otherwise consider remote monitoring necessary.
For participants living at home, an additional criterion is the availability of an electrical outlet for the use of Nemuri SCAN and the ability to bear the associated electricity costs.
Key exclusion criteria
Individuals for whom informed consent to participate in the study cannot be obtained from either the participant or a legally acceptable representative.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Tanabe |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
0822575383
ktanabe2@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Imura |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
0822575853
Homepage URL
hyimura@hiroshima-u.ac.jp
Sponsor or person
Institute
The Yoshiko Shinohara Memorial Foundation
Institute
Department
Personal name
Funding Source
Organization
The Yoshiko Shinohara Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
0822575907
iryo-sinsa@office.hiroshima-u.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 | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2036 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071765
