UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026327 |
|---|---|
| Receipt number | R000030228 |
| Scientific Title | Effect of oral care on improving coughing ability to prevent aspiration pneumonitis |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2023/05/25 08:16:52 |
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Basic information
Public title
Effect of oral care on improving coughing ability to prevent aspiration pneumonitis
Acronym
oral care for coughing ability
Scientific Title
Effect of oral care on improving coughing ability to prevent aspiration pneumonitis
Scientific Title:Acronym
oral care for coughing ability
Region
| Japan |
Condition
Condition
aspiration pneumonitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study is to investigate whether oral care could improve coughing ability and prevent aspiration pneumonitis in elderly people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peak expiratory flow at 6 months after of syrating tongue cleaning
Key secondary outcomes
lingual pressure, swallowing function, appetite improvement, nutrition condition, and autonomic function at 6 months after of syrating tongue cleaning
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group is implemented daily oral care with tongue cleaning for 1 months to 1 year.
Interventions/Control_2
Control group is implemented daily oral care alone for 1 months to 1 year.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Person with agreement to this study.
Key exclusion criteria
Residents with refusal of this study, or with difficulty in communicating.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Akifusa |
Organization
Kyushu Dental University
Division name
Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
+81-93-285-3107
r11akifusa@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | |
| Last name | Izumi |
Organization
Kyushu Dental University
Division name
Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
+81-93-285-3102
Homepage URL
r15izumi@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental University
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka
Tel
093-285-3107
r11akifusa@fa.kyu-dent.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
| 2017 | Year | 05 | 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
58
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030228
