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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019657
Receipt No. 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

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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
Email 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
Email toshinori@med.showa-u.ac.jp

Sponsor
Institute Showa University, Faculty of Medicine, Department of Pediatircs
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022520

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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