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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027657
Receipt No. R000031552
Scientific Title Effect of the Telenursing Intervention Program for the purpose of preventing the acute exacerbation of patients with chronic respiratory failure receiving noninvasive positive pressure ventilation.
Date of disclosure of the study information 2019/06/20
Last modified on 2019/07/11

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Basic information
Public title Effect of the Telenursing Intervention Program for the purpose of preventing the acute exacerbation of patients with chronic respiratory failure receiving noninvasive positive pressure ventilation.
Acronym Effect of the Telenursing Intervention Program for the purpose of preventing the acute exacerbation of patients with chronic respiratory failure receiving noninvasive positive pressure ventilation.
Scientific Title Effect of the Telenursing Intervention Program for the purpose of preventing the acute exacerbation of patients with chronic respiratory failure receiving noninvasive positive pressure ventilation.
Scientific Title:Acronym Effect of the Telenursing Intervention Program for the purpose of preventing the acute exacerbation of patients with chronic respiratory failure receiving noninvasive positive pressure ventilation.
Region
Japan

Condition
Condition Chronic respiratory failure
Classification by specialty
Pneumology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An aim of this study is to investigate the effect of the Telenursing Intervention Program for patients with Chronic respiratory failure receiving Home Noninvasive positive pressure ventilation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the acute exacerbation readmissions and visits
Key secondary outcomes St.George's Respiratory Questionnaire:SGRQ
Euro Qol 5 Dimension:EQ-5D
Self-Care Agency Questionnaire:SCAQ
Spirometry(VC,FEV1.0%)
6-minute walk test:6MWT
steps

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Telenursing Intervention Program participation group
Interventions/Control_2 Usual care group
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Primary disease is respiratory disease
(2)Receiving Home noninvasive positive pressure ventilation
(3)A period of the respiratory failure persisting more than one month
(4)PaO2 45mmHg or over
(5)Being able to operate a tablet PC
Key exclusion criteria (1)Cognitive dysfunction
(2)Cannot speak Japanese
(3)Not being an outpatient
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Fumiko
Middle name
Last name Sato
Organization Tohoku University
Division name Graduate School of Medicine
Zip code 9808575
Address 2-1, Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7926
Email fsato@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Shimoyama
Organization Tohoku University
Division name Graduate School of Medicine
Zip code 9808575
Address 2-1, Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-3889
Homepage URL
Email makoto.shimoyama.r7@dc.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japan Society for The Promotion of Science in MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1, Seiryo-cho, Aoba-ku, Sendai
Tel 022-728-4105
Email med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 20 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 31
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 Completed
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
2017 Year 04 Month 24 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 06 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031552

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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