UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027657 |
|---|---|
| Receipt number | 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 00:20:01 |
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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
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
makoto.shimoyama.r7@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031552
