UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004060
Receipt No. R000004893
Scientific Title Effects of oral care to prevention pneumonia in patients with cerebrovascular diseases in rehabilitation nursing
Date of disclosure of the study information 2010/08/18
Last modified on 2014/09/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of oral care to prevention pneumonia in patients with cerebrovascular diseases in rehabilitation nursing
Acronym Effects of oral care to prevention pneumonia in patients with cerebrovascular diseases in rehabilitation nursing
Scientific Title Effects of oral care to prevention pneumonia in patients with cerebrovascular diseases in rehabilitation nursing
Scientific Title:Acronym Effects of oral care to prevention pneumonia in patients with cerebrovascular diseases in rehabilitation nursing
Region
Japan

Condition
Condition cerebrovascular diseases
Classification by specialty
Pneumology Neurology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to study the effects of oral care on the general conditions in patients with cerebrovascular disease, including the motor nerve function, swallowing function and cognitive function, and to improve the quality of rehabilitation nursing care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Duration or time of fever at 38 degrees centigrade or more, levels of ADL (Activities of Daily Living) and swallowing movement.
Key secondary outcomes Substance P concentration in saliva and serum

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Perform oral care to the patients
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with cerebrovascular disease
Key exclusion criteria Patients judged inappropriate by physicians
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Ohi
Organization National Hospital Organization Hachinohe National Hospital
Division name Nursing section
Zip code
Address 3-13-1 Fukiage, Hachinohe City, Aomori Prefecture, 031-0003, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mutsuo Yamaya
Organization Tohoku University Graduate School of Medicine
Division name Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL 022-717-7284
Homepage URL
Email myamaya@med.tohoku.ac.jp

Sponsor
Institute National Hospital Organization Hachinohe National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Hachinohe National Hospital
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
Address
Tel
Email

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
2010 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 18 Day
Last modified on
2014 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.