UMIN-CTR Clinical Trial

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