UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032084 |
|---|---|
| Receipt number | R000036573 |
| Scientific Title | The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke |
| Date of disclosure of the study information | 2018/04/03 |
| Last modified on | 2018/04/05 11:39:28 |
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Basic information
Public title
The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke
Acronym
The Effect Of Oral Care Protocol For Acute Phase Stroke
Scientific Title
The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke
Scientific Title:Acronym
The Effect Of Oral Care Protocol For Acute Phase Stroke
Region
| Japan |
Condition
Condition
Cerebral Infarction,Cerebral Hemorrhage,Subarachnoid Hemorrhage
Classification by specialty
| Neurology | Neurosurgery | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effect of introducing original oral care protocol for acute phase stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral Cleanliness(Admission Time And After 1 Week)
Key secondary outcomes
Lips,Tongue,Gums,Tissues,Saliva,Natural Teeth,Denture,Dental Pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We introduce an original oral care protocol which describes frequency and procedure of oral care.
We evaluate patient's oral cavity at the time of admission and one week later with OHAT.
We examine the patients with acute phase stroke who depend for "tooth brushing","denture attachment / deattachment" or "gargle" on BDR index.
Evaluators of oral cavity evaluations are the research nurses who studied the evaluation of OHAT before the oral care protocol and after the oral care protocol they are done by the SCU nurse who studied the oral care protocol and OHAT.
Interventions/Control_2
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
At Fukuoka University Chikushi Hospital SCU, there are 50 to 60 new hospitalized patients in about 3 months and there are also patients who are independent in BDR index "tooth brushing", "detaching of denture" and "gargle" at the time of admission, so they are in hospital Of 50 subjects who agreed to consent explanation documents from patients and their families in acute patients with partial assistance or whole-aid stroke, either "toothpaste" "detachment of denture" or "gargle" with BDR index of . In addition, the basics is the first day of hospitalization, but for emergency surgery and nighttime hospitalization the next day evaluation date shall be taken.
Key exclusion criteria
At the time of hospitalization, patients with "Body Toothbrushing", "Removing Denture" and "Mouthwear" all became autonomous at the time of hospitalization, patients who were hospitalized and could not evaluate one week after hospitalization.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kayowada |
Organization
Fukuoka University chikishi Hospital nursing department
Division name
4 th floor stroke care unit
Zip code
Address
1-11chome zokumyoin-in chikushino-shi,fukuoka-ken
TEL
092-921-1011
wadak@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kayowada |
Organization
Fukuoka University Chikushi Hospital
Division name
4 th floor stroke care unit
Zip code
Address
1-11chome zokumyoin-in chikushino-shi,fukuoka-ken
TEL
092-921-1011
Homepage URL
wadak@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
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
Address
Tel
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
| 2018 | Year | 04 | Month | 03 | 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
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036573
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
