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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016376
Receipt No. R000019019
Scientific Title A study on the activity and QOL of patients prescribed Long Term Oxygen Therapy which includes a transportable oxygen concentrator.
Date of disclosure of the study information 2015/01/29
Last modified on 2018/10/29

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Basic information
Public title A study on the activity and QOL of patients prescribed Long Term Oxygen Therapy which includes a transportable oxygen concentrator.
Acronym A study on the activity and QOL of patients prescribed Long Term Oxygen Therapy which includes a transportable oxygen concentrator.
Scientific Title A study on the activity and QOL of patients prescribed Long Term Oxygen Therapy which includes a transportable oxygen concentrator.
Scientific Title:Acronym A study on the activity and QOL of patients prescribed Long Term Oxygen Therapy which includes a transportable oxygen concentrator.
Region
Japan

Condition
Condition chronic respiratory failure patients who need LTOT
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We verify the usefulness of a transportable oxygen concentrator by questionnaire surveys about the activity and QOL of patients initially prescribed LTOT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Activity,QOL
Definition:
We adapt the form of the interval scale to the questionnaire vote, and take a score (5 points to 1 point) to every question. We set the value in the analysis item.
The questions from No.1 to No.4 are about convenience.
The questions from question No.5 to No.8 are about reassurance and safety.
The questions from question No.9 to No.11 are about ecology and design.
The questions from question No.12 to No.18 are about activity and QOL.
The questions from question No.19 to No.20 are about sociality.
Key secondary outcomes sociality
convenience
reassurance and safety
ecology and design
Definition:
We adapt the form of the interval scale to the questionnaire vote, and take a score (5 points to 1 point) to every question. We set the value in the analysis item.
The questions from No.1 to No.4 are about convenience.
The questions from question No.5 to No.8 are about reassurance and safety.
The questions from question No.9 to No.11 are about ecology and design.
The questions from question No.12 to No.18 are about activity and QOL.
The questions from question No.19 to No.20 are about sociality.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Group A
Using oxygen concentrators in order of 1. to 3. each by about a month.
1.transportable->2.stationary->3.semi-transportable
Interventions/Control_2 Group B
Using oxygen concentrators in order of 1. to 3. each by about a month.
1.semi-transportable->2.transportable->3.stationary
Interventions/Control_3 Group C
Using oxygen concentrators in order of 1. to 3. each by about a month.
1.stationary->2.semi-transportable->3.transportable
Interventions/Control_4 Group D
Using oxygen concentrators in order of 1. to 3. each by about a month.
1.transportable->2.semi-transportable->3.stationary
Interventions/Control_5 Group E
Using oxygen concentrators in order of 1. to 3. each by about a month.
1.semi-transportable->2.stationary->3.transportable
Interventions/Control_6 Group F
Using oxygen concentrators in order of 1. to 3. each by about a month.
1.stationary->2.transportable->3.semi-transportable
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 (1) The patients of chronic respiratory failure due to COPD etc.
(2) The patients initially prescribed LTOT.
(3)The patients who can walk alone and answer a questionnaire.
(4) The patients who agreed to submit informed consent before this study.
Key exclusion criteria (1) The patients with the prescription of oxygen dose more than 3L/min.
(2) The patients whose treatment period of LTOT is expected to be less than three month.
(3) The patients who has difficulty in answering questionnaire orally or by written.
(4) The patients who are performed respiratory management by tracheotomy.
(5) In addition, the patients who was judged as inappropriate for the candidate by a doctor.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Medical Center
Division name Respiratory disease center
Zip code
Address 4-57 Urafunemachi, Minamiku, Yokohamashi Kanagawa232-0024,Japan
TEL 045-261-5656
Email shinkai@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Shinoda
Organization Yokohama City University Medical Center
Division name Respiratory disease center
Zip code
Address 4-57 Urafunemachi, Minamiku, Yokohamashi Kanagawa232-0024,Japan
TEL 045-261-5656
Homepage URL
Email smarou@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization AIR WATER MEDICAL Inc.
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
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 横浜市立大学附属市民総合医療センター(神奈川県)、済生会横浜市南部病院(神奈川)、関東労災病院(神奈川)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 29 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 Terminated
Date of protocol fixation
2014 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 29 Day
Last follow-up date
2017 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 29 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019019

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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