UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040008 |
|---|---|
| Receipt number | R000045604 |
| Scientific Title | Impact of educational interventions on oral care to elderly people living in long-term nursing homes - pilot study. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/10/03 08:37:54 |
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Basic information
Public title
Impact of an oral care education to elderly people living in long-term nursing homes.
Acronym
Impact of an oral care education to elderly people living in long-term nursing homes.
Scientific Title
Impact of educational interventions on oral care to elderly people living in long-term nursing homes - pilot study.
Scientific Title:Acronym
Impact of educational interventions on oral care to elderly people living in long-term nursing homes.
Region
| Japan |
Condition
Condition
Oral hygiene
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess improvement of oral care interventions for elderly people who can do oral care by themselves living in nursing care facilities for the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total score of Oral Assessment Guide in two weeks after intervention
Key secondary outcomes
Sub scores of Oral Assessment Guidein two weeks after intervention
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
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
The subject's in control do oral care by themselves as usual.
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
Persons who can do oral care by themselves with independence or with partial compensatory care.
Key exclusion criteria
Persons who can not do oral care by themselves at all.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kanetaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Health Sciences University of Hokkaido
Division name
Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Zip code
061-0293
Address
1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
TEL
0133232874
k-yamaguchi@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanetaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Health Sciences University of Hokkaido
Division name
Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Zip code
061-0293
Address
1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
TEL
0133232874
Homepage URL
k-yamaguchi@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Fixed Prosthodontics and Oral Implantology Department of Oral Rehabilitation
Address
1757 Kanazawa, Ishikari-Tobetsu Hokkaido 061-0293, JAPAN
Tel
0133232874
k-yamaguchi@hoku-iryo-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
| 2020 | Year | 04 | Month | 01 | 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
| 2020 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045604
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
