UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037768 |
|---|---|
| Receipt number | R000042884 |
| Scientific Title | Intervention of oral care to elderly people living in long-term nursing homes |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2024/08/27 17:05:15 |
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Basic information
Public title
Intervention of oral care to elderly people living in long-term nursing homes
Acronym
Intervention of oral care to elderly people living in long-term nursing homes
Scientific Title
Intervention of oral care to elderly people living in long-term nursing homes
Scientific Title:Acronym
Intervention of oral care to elderly people living in long-term nursing homes
Region
| Japan |
Condition
Condition
oral nursing
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to provide oral care interventions for elderly people living in nursing care facilities for the elderly, and to provide partial oral assistance for oral care. It is to compare the improvement degree.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Assessment Guide
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group:The intervention group directs oral care after baseline sampling.
From the next day until the next sampling, the subject will perform oral cleaning for 2 minutes using a mucosal brush for oral care after lunch for 2 minutes.
Interventions/Control_2
Control group:Normal oral care by the subject himself
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Oral care independence: Persons with independence and partial compensatory care
Key exclusion criteria
Oral care independence: All assistance Persons who cannot do oral self-care
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | MASUMI |
| Middle name | |
| Last name | MURAMATSU |
Organization
Sapporo City University
Division name
Department of Nursing, School of Nursing
Zip code
060-0011
Address
N-11,W-13,Chuou-ku,Sapporo
TEL
011-726-2681
m.muramatsu@scu.ac.jp
Public contact
Name of contact person
| 1st name | MASUMI |
| Middle name | |
| Last name | MURAMATSU |
Organization
Sapporo City University
Division name
Department of Nursing, School of Nursing
Zip code
060-0011
Address
N-11,W-13,Chou-ku,Sapporo
TEL
011-726-2681
Homepage URL
m.muramatsu@scu.ac.jp
Sponsor or person
Institute
Department of Nursing, School of Nursing,Sapporo City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City University
Address
N-11,W-13Sapporo,Chou-ku,
Tel
011-726-2681
m.muramatsu@scu.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 | 08 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ethics committee approval was not obtained.
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042884
