UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007299 |
|---|---|
| Receipt number | R000008525 |
| Scientific Title | Impacts of the Disaster with Earthquake, Tsunami, and Nuclear Power Plant Accident of March 11, 2011, in Fukushima on Asthma Control |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2012/02/15 14:37:43 |
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Basic information
Public title
Impacts of the Disaster with Earthquake, Tsunami, and Nuclear Power Plant Accident of March 11, 2011, in Fukushima on Asthma Control
Acronym
The evaluation of Asthma Control after the disaster.
Scientific Title
Impacts of the Disaster with Earthquake, Tsunami, and Nuclear Power Plant Accident of March 11, 2011, in Fukushima on Asthma Control
Scientific Title:Acronym
The evaluation of Asthma Control after the disaster.
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the effect of this complex disaster on asthma by evaluating asthmatics treated and followed continuously in our outpatient clinic of Fukushima Medical University Hospital.
Basic objectives2
Others
Basic objectives -Others
The interview using questionnaire to evaluate the damage by the disaster, the changes in life style, and the availability of anti-asthmatic drugs was performed , and the status of asthma control and psychological status of the patients were evaluated using visual analogue scale (VAS).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigated the effect of this disaster on asthma control.
Key secondary outcomes
We evaluated the physical and psychological status of asthmatics during and after the disaster.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are diagnosed with asthma, and they have been treated and followed continuously at the outpatient clinic of Fukushima Medical University Hospital.
Key exclusion criteria
nothing
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Sato |
Organization
Fukushima Medical University School of Medicine
Division name
Departmentof Pulmonary Medicine
Zip code
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1360
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Sato |
Organization
Fukushima Medical University School of Medicine
Division name
Departmentof Pulmonary Medicine
Zip code
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1360
Homepage URL
pulmo@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine. Departmentof Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University School of Medicine. Departmentof Pulmonary Medicine
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
福島県立医科大学附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is known that natural disasters such as earthquake result worsening of chronic diseases including ischemic heart disease, diabetes mellitus, and asthma.
In this study, we investigated the effect of this disaster on asthma by evaluating asthmatics treated and followed continuously in our outpatient clinic of Fukushima Medical University Hospital.
Management information
Registered date
| 2012 | Year | 02 | Month | 15 | Day |
Last modified on
| 2012 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008525
