UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062998 |
|---|---|
| Receipt number | R000072120 |
| Scientific Title | A Study on the Effectiveness of a Contact Detection System for Removing Physical Restraints in Older People with Cognitive Decline Who Self-Remove IV Drips and Tubes |
| Date of disclosure of the study information | 2026/09/20 |
| Last modified on | 2026/09/20 10:19:35 |
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Basic information
Public title
Nursing research on the prevention of self-removal of intravenous drips and tubes by older people with cognitive decline
Acronym
Nursing research on the prevention of self-removal of intravenous drips and tubes by older people with cognitive decline
Scientific Title
A Study on the Effectiveness of a Contact Detection System for Removing Physical Restraints in Older People with Cognitive Decline Who Self-Remove IV Drips and Tubes
Scientific Title:Acronym
A Study on the Effectiveness of a Contact Detection System for Removing Physical Restraints in Older People with Cognitive Decline Who Self-Remove IV Drips and Tubes
Region
| Japan |
Condition
Condition
Risk of self-removal among older people with cognitive decline
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With a view to minimizing the use of physical restraints on older people with cognitive impairment, this study evaluates the use of a contact detection system by clinical nurses and examines the potential for the removal of physical restraints through the use of this system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of physical restraint, Duration of physical restraint, System Detection rate, Failure rate and Number of false alarms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participating nurses will be asked to use the contact detection system for approximately three months. We will compare the occurrence and duration of physical restraint removal between the group using the system and the group not using it (control_2). We will also evaluate the system's detection rate, failure rate and number of false alarms, as well as the nurses' perceptions of the system.
Interventions/Control_2
Control group. This group will be monitored for approximately three months, without the use of a contact detection system, to determine whether physical restraints have been removed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ward nurses
Those who have been briefed on the study and have obtained the patient's consent.
Those who have been briefed on the system and are able to use it.
Target patients
Elderly patients with intravenous drips or tubes in place who are at risk of self-removal, such as those with impaired cognitive function or a history of removal.
Patients who have been briefed on the study and for whom consent has been obtained from the patient themselves or a key person involved in decision-making.
Patients for whom the attending doctor or ward manager has determined that the system can be used.
Key exclusion criteria
Ward Nurse
A nursing manager who does not provide direct care to patients.
Target Patients
Those who do not have key persons involved in decision-making, such as family members.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Amemiya |
Organization
Chiba University
Division name
Graduate school of Nursing
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2402
amemiya-a@chiba-u.jp
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Maeda |
Organization
Chiba University
Division name
Graduate school of Nursing
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-251-1111
Homepage URL
fumaeda@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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 Review Committee, Graduate School of Nursing, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-251-1111
kango-rinri@chiba-u.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 | 09 | Month | 20 | 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 | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 20 | Day |
Last modified on
| 2026 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072120
