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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041109
Receipt No. R000046949
Scientific Title The value of vital sign trends in predicting hospital admission in interstitial lung disease patients receiving home oxygen therapy.
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/15

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Basic information
Public title The value of vital sign trends in predicting hospital admission in interstitial lung disease patients receiving home oxygen therapy.
Acronym The value of vital sign trends in predicting hospital admission in interstitial lung disease patients receiving home oxygen therapy.
Scientific Title The value of vital sign trends in predicting hospital admission in interstitial lung disease patients receiving home oxygen therapy.
Scientific Title:Acronym The value of vital sign trends in predicting hospital admission in interstitial lung disease patients receiving home oxygen therapy.
Region
Japan

Condition
Condition Interstitial lung disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the value of vital sign trends in predicting hospital admission in interstitial lung disease patients.
Basic objectives2 Others
Basic objectives -Others Assessment of predictive factors for hospital admission
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between hospital admission risk and the trends in vital signs including SpO2 and body temperature.
Key secondary outcomes The relationship between hospital admission risk and clinical symptoms.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Interstitial lung disease patients
-Patients receiving home oxygen therapy
Key exclusion criteria -Whose attending doctors considered ineligible
-Who receive nasal oxygen more than 5L/min
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Sakae
Middle name
Last name Homma
Organization Toho University Omori Medical Center
Division name Department of Advanced and Intergrated Interstitial Lung Diseases Research
Zip code 143-8541
Address 5-21-16, Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Email sahomma@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Sakae
Middle name
Last name Homma
Organization Toho University Omori Medical Center
Division name Department of Advanced and Intergrated Interstitial Lung Diseases Research
Zip code 143-8541
Address 5-21-16, Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Homepage URL
Email sahomma@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Teijin-Pharma Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical ethics committee of Toho University Omori Medical Center
Address 6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
Tel 03-3762-4151(3132)
Email omori.rinri@ext.toho-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 東邦大学医療センター大森病院(東京都)
Toho University Omori Medical Center(Tokyo)

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 15 Day
Date of IRB
2020 Year 01 Month 10 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Observational study
Study period: August 31, 2019 to March 31, 2022

Management information
Registered date
2020 Year 07 Month 15 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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