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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name