UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038524 |
|---|---|
| Receipt number | R000043905 |
| Scientific Title | Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service |
| Date of disclosure of the study information | 2019/11/08 |
| Last modified on | 2019/11/08 19:20:18 |
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Basic information
Public title
Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Acronym
Intervention study on the implementation of oral function improvement services
Scientific Title
Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Scientific Title:Acronym
Intervention study on the implementation of oral function improvement services
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate all the facility users and to grasp the current situation, and to provide oral function improvement services to the target persons with the aim of improving oral function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Diadocokinesis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Provision of individual oral function improvement services by dental hygienists
Interventions/Control_2
Provision of overall oral function improvement services by dental hygienists
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who need support 1 or 2 of the elderly health care facility Watatsumi Day Care users and who have consented to this study
Key exclusion criteria
Those who did not obtain consent for this study
People over 100 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | MIHO |
| Middle name | |
| Last name | MANABE |
Organization
Mitoyo General Hospital
Division name
Department of Dental Hygiene
Zip code
769-1695
Address
708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
TEL
0875-52-3366
candypop_666@yahoo.co.jp
Public contact
Name of contact person
| 1st name | MIHO |
| Middle name | |
| Last name | MANABE |
Organization
Mitoyo General Hospital
Division name
Department of Dental Hygiene
Zip code
769-1695
Address
708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
TEL
0875523366
Homepage URL
candypop_666@yahoo.co.jp
Sponsor or person
Institute
Mitoyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Mitoyo General Hospital
Address
708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
Tel
0875-52-3366
candypop_666@yahoo.co.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 | 11 | Month | 08 | 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
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 11 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2019 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043905
| 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 |
