UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004060 |
|---|---|
| Receipt number | 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 13:30:43 |
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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
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
myamaya@med.tohoku.ac.jp
Sponsor or person
Institute
National Hospital Organization Hachinohe National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004893
