UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054753 |
|---|---|
| Receipt number | R000062533 |
| Scientific Title | Clinical evaluation of visual feedback from pressure mapping to optimise patient repositioning |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2025/06/25 09:10:09 |
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Basic information
Public title
Clinical evaluation of visual feedback from pressure mapping to optimise patient repositioning
Acronym
Clinical evaluation of visual feedback from pressure mapping to optimise patient repositioning
Scientific Title
Clinical evaluation of visual feedback from pressure mapping to optimise patient repositioning
Scientific Title:Acronym
Clinical evaluation of visual feedback from pressure mapping to optimise patient repositioning
Region
| Japan |
Condition
Condition
Patients requiring palliative care who fall into either 1 or 2
1 Patients who fall into the "Rank B.C: Bedridden" level of independence in daily living 2 Patients with pressure ulcers
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate two changes with the use of a 'fully automatic actuated pressure-switching air mattress' with mapping of trunk pressures at high risk of developing pressure ulcers:
1. patient distress 2. pressure ulcer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edomonton Symptom Assessment System Reviced Japanese version "ESAS -r-J" Well-Being
Key secondary outcomes
1. OSA sleep inventory MA version
2. Items other than Well-Being of the Edmonton Symptom Assessment System Reviced Japanese version; ESAS -r-J
3. Pressure Sore Status Tool
4. DESIGN-R2020 (with pressure ulcer)
5. Occurrence including skin reaction hyperemia (no pressure ulcer)
6. EQ-5D-5L(Japanese ver.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention group use of 'fully automatic operating pressure-switching air mattress' with the pressure mapping monitor: Molten Scope (A).
Interventions/Control_2
The subject group with `fully automatic pressure switching air mattresses' without pressure mapping monitor: Molten Scope Light(B).
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. Patients who have given their free and voluntary written consent to participate in this study, after having been fully informed and with full understanding.
2. patients aged 20 years or older at the time of consent
3. patients who have been assessed as being at risk of developing pressure ulcers according to the OH Scale (Pressure Ulcer Assessment Scale).
Key exclusion criteria
1. Patients deemed unsuitable by the treating physician
2. Other patients deemed inappropriate by the principal investigator or research assistant.
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Hiroe |
| Middle name | |
| Last name | Koyanagi |
Organization
Fujita Health University
Division name
School of Health Sciences Nursing Science
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-2656
hiroe.koyanagi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroe |
| Middle name | |
| Last name | Koyanagi |
Organization
Fujita Health University
Division name
School of Health Sciences Nursing Science
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-2656
Homepage URL
hiroe.koyanagi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Others
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
fujita
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562-93-2656
hiroe.koyanagi@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
藤田医科大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062533
