UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037746 |
|---|---|
| Receipt number | R000043006 |
| Scientific Title | A randomized, open-label, crossover study |
| Date of disclosure of the study information | 2019/09/20 |
| Last modified on | 2023/02/03 14:17:08 |
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Basic information
Public title
A pilot study for development for the assistive device
Acronym
A pilot study for development for the assistive device
Scientific Title
A randomized, open-label, crossover study
Scientific Title:Acronym
A randomized, open-label, crossover study
Region
| Japan |
Condition
Condition
patient turning and repositioning
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy of the assistive device for caregivers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time for bending forward of caregivers
Key secondary outcomes
subjective fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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 method of patient turning and repositioning with assistive device
Interventions/Control_2
the method of patient turning and repositioning in standard way
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
who have given written consent to participate in the research
nurses or nursing staff working at the facilities where research is planning
who have clinical experience of patient turning and repositioning and diaper exchange
Key exclusion criteria
who have not changed turning and patient repositioning and diaper due to health reasons
who have trouble in patient care due to low back pain
who are judged to be inappropriate for inclusion in research by research director
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hirata |
Organization
Osaka university
Division name
Graduate school of medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
06-6210-8429
mhirata@ndr.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
Osaka university
Division name
Graduate school of medicine
Zip code
565-0871
Address
1-7, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
06-6879-2526
Homepage URL
y-omura@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
FUNAI ELECTRIC CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Mitsubishi foundation
Osaka University MEI grant 2018
Osaka University Innovation bridge grant
IRB Contact (For public release)
Organization
Osaka University
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-022-21800-5
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-022-21800-5
Number of participants that the trial has enrolled
30
Results
Trunk flexion time and percentage of time were 26.5 s (95% confidence interval: 14.1 s, 38.9 s) (p < 0.001) and 23.0% (95% confidence interval: 16.4%, 29.6%) (p < 0.001) lower, respectively, in the Device group than in the Manual group. Furthermore, caregivers evaluated the care they could administer with the device as being better than that associated with manual care.
Results date posted
| 2023 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included care workers and nurses aged 20-60 years, with clinical experience in lateral turning and changing diapers who worked at the facility where the study was conducted in Osaka, Japan. We excluded care workers and nurses with health conditions that might have interfered with the care protocol and those with severe low back pain, which might have worsened by participating in the study.
Participant flow
Staff members who worked at the facility where the research was conducted and were on the day shift on the day of the study, agreed to participate in the study, and fulfilled the eligibility criteria were included in the study.
Adverse events
none
Outcome measures
The trunk flexion angle, Working time, Subjective fatigue, and usability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
