UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019657 |
|---|---|
| Receipt number | R000022520 |
| Scientific Title | The exploratory study of the effect on adherence improvement of the electronic edition bornchial asthma diary: Crossover randomized controlled trial |
| Date of disclosure of the study information | 2015/11/15 |
| Last modified on | 2015/11/06 10:56:14 |
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Basic information
Public title
The exploratory study of the effect on adherence improvement of the electronic edition bornchial asthma diary: Crossover randomized controlled trial
Acronym
The exploratory study of the effect on adherence improvement of smartphone diary
Scientific Title
The exploratory study of the effect on adherence improvement of the electronic edition bornchial asthma diary: Crossover randomized controlled trial
Scientific Title:Acronym
The exploratory study of the effect on adherence improvement of smartphone diary
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate whether patient's adherence is improved by using a smartphone record than using a conventional paper record.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The compliance rate of inhale corticosteroids during 3 months.
Key secondary outcomes
Change of Asthma control test and recording rate of diaries at 3 months.
Patient's choice which diary to use after finishing the study.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The patients use the smartphone record for 3 months after registration, and use the conventional paper record following 3 months.
Interventions/Control_2
The patients use the conventional paper record for 3 months after registration, and use the smartphone record following 3 months.
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who have been diagnosed as bronchial asthma and prescribed more than 100 mcg per a day of inhale corticosteroids of Fluticason equivalent.
Key exclusion criteria
The patients who is not able to change their inhale corticosteroids to the one with dose-counter.
The patients who has congenital anomaly, congenital heart disease, and other chronic disease with respiratory distress.
The patients who cannot be obtained informed consent by themselves or their guardians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Imai Takanori |
Organization
Showa University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
Address
1-5-8 Hatanodai, Shinagawa ku, Tokyo
TEL
0337848565
ta-imai@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Nakamura |
Organization
Showa University, Faculty of Medicine
Division name
Department of pediatrics
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
0337848565
Homepage URL
toshinori@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University, Faculty of Medicine, Department of Pediatircs
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency, Independent Administrative Institutions
Organization
Division
Category of Funding 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022520
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
