UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042822 |
|---|---|
| Receipt number | R000048887 |
| Scientific Title | Test of care tasks with humans using a new technology of raising a bedridden person off the bed. |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2021/12/14 21:01:45 |
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Basic information
Public title
Test of a new lifting technology & device to reduce the load of caregivers working for bedridden persons.
Acronym
Test of a new lifting technology & device for bed ridden persons.
Scientific Title
Test of care tasks with humans using a new technology of raising a bedridden person off the bed.
Scientific Title:Acronym
Test of care tasks using a new technology of raising a person off the bed.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Feasibility of the new lifting technology & device, which utilizes Japanese futon, to care tasks, its comparative evaluation with the current care technology & device, and the evaluation of the reduction of the physical load on caregiver performers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasible or non-feasible experimental facts of the new lifting technology & device to care tasks for bedridden persons. The results will be obtained at the end of the experiments.
Key secondary outcomes
1.Physical load of the caregiver performers using the new technology in comparison with the current one.
2.Comfort or discomfort of care-receiver performers using the new technology in comparison with the current one.
3.Appearance, symmetry and tidiness of the bed after the care tasks using the new technology in comparison with the current one.
4.Required time for care tasks using the new technology in comparison with the current one.
The results will be obtained at the end of the experiments.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
After confirming the applicability of the new technology & the device to care tasks for bedridden persons, 15 pairs of healthy persons participate in the bedsheets change test of an occupied bed. Each of the pair uses the new technology and the current technology, and also alternating the roles of a caregiver and a care-receiver, tries 4 different cases and evaluate them comparatively. The test period is about 3 months.
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
Those healthy persons who have the skill of the current technology of the care tasks such as bedsheets change.
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Ohno |
Organization
Osaka University
Division name
Division of Health Science, Graduate School of Medicine
Zip code
5650871
Address
1-7 Yamadaoka, Suita City, Osaka Pref.
TEL
06-6879-2614
ohno@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Okada |
Organization
Osaka University
Division name
Division of Health Science, Graduate School of Medicine
Zip code
5650871
Address
1-7 Yamadaoka, Suita City, Osaka Pref.
TEL
06-6879-2526
Homepage URL
25b14804@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Division of Health Science, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
1.Prop Co., Ltd.
2.Paramount Bed Co., Ltd.
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
2-2 Yamadaoka, Suita City, Osaka Pref.
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
大阪大学大学院医学系研究科保健学専攻（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
http://sahswww.med.osaka-u.ac.jp/~fnmet/index.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
New tech: making a futon wavy under a person, belts being inserted to wave troughs, tied to a frame, the bed being lowered to lift the person. Feasibility tests: 1. a device set to an occupied bed, 2. sheets change, 3. change upper body clothes & 4. lower ones, 5. bed bath, 6. bedpan insertion, 7. move to a wheelchair, 8. sheet wrinkle removal. All but 3 & 5 were done well. Changing futon sheets with new & current methods by 30 participants: new tech was feasible, giving tidy sheets, but taking longer time.
Results date posted
| 2021 | Year | 12 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants: 8 males, 22 females
mean age: 33.7 (SD 10.4) years
mean height: 163.4 (SD 9.2) cm
mean weight: 59.4 (SD 12.1) kg
nurses & midwives (active & former):15
finishers of nursing course: 11
finishers of non-nursing course: 4
Participant flow
Through the teaching staffs whose laboratories were in the same Department where the researchers were based, the participants were recruited, and got 30 applicants. All of them met the inclusion criteria and were enrolled in the test. Though, this was a single arm test, as there existed the orders of the test, i.e. (1) the new technology and device, (2) the current method, or (1) the current method, (2) the new technology, about half of the pair began the test with the new technology and device, and the rest with the current method. The data of 30 participants were used for analyses.
Adverse events
none.
Outcome measures
･Feasibility of the new technology & device to care tasks.
･The paired differences of the following variables evaluated by the participants in the test of futon sheets change between using the new technology & device and the current method.
1.Subjective physical load of the simulated caregivers.
2. Subjective comfort or discomfort of the simulated care-receivers.
3. Appearance of the changed sheet.
4. The required time.
Plan to share IPD
none.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 23 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
As for the principles of a wavy futon formation and the insertion of belts between a person and the futon in the Result Column, reference: example 20 and Fig. 11 of WO 2019/027037 A1.
Management information
Registered date
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048887
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