UMIN-CTR Clinical Trial

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
Email	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
Email	25b14804@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Division of Health Science, Osaka University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048887