UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058410 |
|---|---|
| Receipt number | R000066777 |
| Scientific Title | Nursing care process intervention using LIFE information |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/09 13:01:22 |
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Basic information
Public title
Nursing care process intervention using LIFE information
Acronym
Nursing care process intervention using LIFE information
Scientific Title
Nursing care process intervention using LIFE information
Scientific Title:Acronym
Nursing care process intervention using LIFE information
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of care provided using a care manual that enables practical leaders (care managers, care workers, etc.) to develop care plans utilizing LIFE information, with a focus on improving the activities of daily living (ADL) of older residents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The propotion of older people whose Barthel Index (BI) improved by 10 points or more in the intervention group and the control group.
Key secondary outcomes
Change in Barthel Index (BI) (mean value) between the intervention group and the control group
Assess the presence or absence of changes over 12 weeks in the following items included in the care manual: LIFE-related information, Simplefied Activities of Daily Living and Cognitive Function Scale, ICF staging, Vitality Index, ASCOT, etc.
Questionnaire targeting practice leaders and care facility staff.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Manual for developing nursing care plans
Interventions/Control_2
normal nursing care
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Practical leaders>
1. Among the staff of long-term care facilities who are in charge of residents of long-term care facilities, those who are in a practical position and take the lead in tasks such as drawing up care plans (care managers, counselors, certified care workers, etc.)
2. Long-term care facility staff who have given their consent to cooperate with this research
<Facility users>
1.Those for whom the practical leader is in charge of providing long-term care services
2.Those aged 65 and over
3.Those who are conscious and have separate sleeping and eating areas
4.Those who have given their consent to cooperate with this research, either themselves or through a proxy
<Nursing home staff>
1.Nursing home staff in charge of residents at the selected long-term care facility (care managers, certified care workers, care staff, nurses, physical therapists, occupational therapists, speech-language-hearing therapists, dieticians, etc.)
2.Nursing home staff who have given their consent to cooperate with this research
Key exclusion criteria
<Practical leaders>
1.Caregiving facility staff who are judged to be inappropriate by the principal investigator or a member of the research team
<Facility users>
1.People who are expected to leave the facility while receiving care using this educational tool
2.People who are judged to be inappropriate by the principal investigator or a member of the research team
<Nursing home staff>
1.Nursing home staff who are judged to be inappropriate by the principal investigator or a member of the research team
Target sample size
490
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Gerontology and Social Sciences
Zip code
4748511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-2311
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Ohura |
Organization
National Center for Geriatrics and Gerontology
Division name
Evidence-based Long-term Care Team, Center for Gerontology and Social Sciences
Zip code
4748511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-2311
Homepage URL
ohura@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, National Center for Geriatrics and Gerontology (NCGG)
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2025 | Year | 07 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2025 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066777
