UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses in the Stroke Care Unit
Acronym	Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses
Scientific Title	Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses in the Stroke Care Unit
Scientific Title:Acronym	Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses
Region	Japan

Condition
Condition	Acute stage of stroke
Classification by specialty	Neurosurgery Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will clarify the changes in practical skills of SCU nurses' oral care by introducing oral care protocol.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Four items and consciousness (8 items), knowledge (4 items), technology (4 items), awareness and knowledge, technology and promotion of activities before and after the use of the oral care protocol, questionnaire survey conducted, consciousness and knowledge, 11 items), promotion of activities (5 items), the change in the total score (after introduction and before introduction) is the main evaluation item. Main evaluation items are compared before and after introduction by Paired-t test.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Perform questionnaire surveys before and after the oral care protocol introduction. The contents of the questionnaire are "5: Very applicable", "4: It is quite true", "3: Extremely applicable", "3: Extremely applicable", "3: : Approximately applicable "" 2: Not very applicable "" 1: Not applicable at all ", and a partial multiple answer format.
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	All 25 SCU nurses involved in nursing patients in the acute phase of stroke
Key exclusion criteria	SCU nurse manager (nurse president, chief nurse) involved in nursing patients in the acute phase of stroke
Target sample size	23

Research contact person
Last name of lead principal investigator	1st name kayo Middle name Last name wada
Organization	Fukuoka University Chikushi Hospital Nursing department
Division name	4 th floor SCU
Zip code	8188502
Address	Fukuoka prefecture Chikushino city zokumyouin 1 - chome 1 - 1
TEL	0929211011
Email	wadak@fukuoka-u.ac.jp

Public contact
1st name of contact person	1st name chiaki Middle name Last name komoda
Organization	Fukuoka University Chikushi Hospital
Division name	4 th floor SCU
Zip code	8188502
Address	Fukuoka prefecture Chikushino city zokumyouin 1 - chome 1 - 1
TEL	0929211011
Homepage URL
Email	komo@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

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	Fukuoka University Chikushi Hospital
Address	Fukuoka prefecture Chikushino city zokumyouin 1 - chome 1 -1
Tel	0929211011
Email	komo@fukuoka-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	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	44
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	2018 Year 01 Month 29 Day
Date of IRB	2018 Year 04 Month 13 Day
Anticipated trial start date	2018 Year 06 Month 04 Day
Last follow-up date	2019 Year 04 Month 28 Day
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 02 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036515