UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016376 |
|---|---|
| Receipt number | 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 08:53:35 |
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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
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
smarou@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019019
