UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053148 |
|---|---|
| Receipt number | R000060342 |
| Scientific Title | Verification of the Effectiveness of Digital Transformation (Dx) in Nursing Homes to Improve the Nursing Care Environment |
| Date of disclosure of the study information | 2023/12/27 |
| Last modified on | 2023/12/18 21:08:10 |
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Basic information
Public title
Verification of the Effectiveness of Digital Transformation (Dx) in Nursing Homes to Improve the Nursing Care Environment
Acronym
Verification of the Effectiveness of Digital Transformation (Dx) in Nursing Homes
Scientific Title
Verification of the Effectiveness of Digital Transformation (Dx) in Nursing Homes to Improve the Nursing Care Environment
Scientific Title:Acronym
Verification of the Effectiveness of Digital Transformation (Dx) in Nursing Homes
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether digital transformation (Dx), such as (1) power-assistive suits, (2) robotic walkers, and (3) bed release sensors, monitoring cameras, and nurse call interlocking services, improves the nursing environment by reducing the burden and fatigue of caregivers and improving the level of well-being of caregivers and the satisfaction of care recipients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoints: Questionnaire survey
1) Low back pain: NRS, JOABPEQ, Oswestry Disability Index, questionnaire survey based on abbreviated version of Pain Detect
2) Lower limb pain: NRS
3) Fatigue: modified Borg scale (Borg G. Scand J Work Environ Health. 1990, 16(1): 55-58)
4) Happiness: 11-point scale.
Key secondary outcomes
Secondary endpoints
1) Muscle strength: back strength, grip strength, lower limb strength
2) Blood pressure and pulse rate: Measured by wearable device (Fitbit)
3) QOL assessment: SF-8, EuroQOL 5 dimensions (EQ-5D)
4) Berg Balance Scale
5) 10 meter walk test
6) Timed Up and Go test
7) Body fat and skeletal muscle mass measurement with Inbody
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The power-assistive suit will be used or not used for 4 weeks for transfer assistance tasks within the workday, followed by a 2-week pause, and then 4 weeks of work with or without the power-assistive suit.
Interventions/Control_2
We will survey 30 care recipients who are able to respond to a questionnaire survey, by means of questionnaires (back pain, leg pain, average fatigue level, and happiness level), to determine their situation and satisfaction level in care depending on whether the caregiver uses a power-assisted suit or not.
Interventions/Control_3
A crossover study will be conducted with two groups: a group that will practice walking with the robotic walker for 20-40 minutes per day for 4 weeks, then discontinue walking practice for 2 weeks, and then practice walking with the regular walker for 20-40 minutes per day for 4 weeks and evaluate the results weekly, and a group that will practice walking with the regular walker for 20-40 minutes per day for 4 weeks, then discontinue walking practice for 2 weeks , and then practice walking with the robotic walker for 20-40 minutes per day for 4 weeks and evaluate the results weekly.
Interventions/Control_4
The use of the bed release sensor will be examined in a crossover study in which one group will be evaluated weekly for 1 week of use of the bed release sensor, then 1 week of non-use of the bed release sensor, and then 1 week of non-use of the bed release sensor.
The use of the bed release sensor will be examined in a crossover study in which one group will be evaluated weekly during one week of use of the bed release sensor and the other group will be evaluated weekly during one week of non-use of the bed release sensor.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Caregivers and caregivers at the "Nishiki-en" long-term care health facility for the elderly, the "Tazawa-no-Sato" long-term care health facility for the elderly, and the "Sawayaka Sakurakan" private-pay nursing home for the elderly in Senboku City, Akita Prefecture
(2) Persons who have consented to this study by signing a consent form.
Key exclusion criteria
(1) Pain due to musculoskeletal disorders such as back pain and leg pain that make it difficult to perform transfer assistance tasks.
(2) Difficulty in performing tasks and transfers due to cardiovascular, respiratory, endocrine, or other diseases
(3) Severe paralysis due to cranial nerve disease or spinal cord disease that makes transferring difficult
(4) Inability to answer self-administered questionnaires due to cognitive decline
(5) Inability to walk unaided or instability in walking unaided with the possibility of falling
(6) Unable to agree to the purpose of this study or sign the consent form
(7) Other participants who are considered inappropriate to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kasukawa |
Organization
Akita University Hospital
Division name
Division of Rehabilitation Medicine
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6148
kasukawa@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kasukawa |
Organization
Akita University Hospital
Division name
Division of Rehabilitation Medicine
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6148
Homepage URL
kasukawa@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
Akita University Graduate School of Medicine and Faculty of Medicine Ethics Committee
Address
1-1-1 Hondo, Akita
Tel
018-884-6028
soken@hos.akita-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
| 2023 | Year | 12 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060342
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