UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048988 |
|---|---|
| Receipt number | R000055806 |
| Scientific Title | Changes in control status and medication adherence in asthmatic children due to the introduction of a new asthma management application |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2025/03/25 09:19:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes in control status and medication adherence in asthmatic children due to the introduction of a new asthma management application
Acronym
Changes in control status and medication adherence in asthmatic children due to the introduction of a new asthma management application
Scientific Title
Changes in control status and medication adherence in asthmatic children due to the introduction of a new asthma management application
Scientific Title:Acronym
Changes in control status and medication adherence in asthmatic children due to the introduction of a new asthma management application
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the efficacy of the application on bronchial asthma control status, medication adherence, and quality of life by introducing a new asthma application to asthmatic children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of control status between the asthma app group and the asthma diary group
Key secondary outcomes
1.Comparison of adherence to inhalation and oral medication between the asthma app group and the asthma diary group
2.Comparison of frequency of asthma attack between the asthma app group and the asthma diary group
3.Comparison of quality of life for caregivers of asthmatic children before and after study participation between the asthma app group and the asthma diary group
4.Comparison of post-use convenience evaluation between the asthma app group and the asthma diary group
5.Comparison of pulmonary function test results at outpatient visits between the asthma app group and the asthma diary group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Introduction of new asthma application
Interventions/Control_2
Introduction of asthma diary
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
| 4 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients receiving regular outpatient treatment to Osaka Metropolitan University Hospital, Department of Pediatrics, Osaka Red Cross Hospital, Department of Pediatrics or Osaka Habikino Medical Center,Department of Pediatrics
2.Patients who can perform respiratory function test and spirometer
3.Patients taking inhalation therapy regularly at the start of the study
4.Patients with moderate or higher asthma severity at the start of the study
Key exclusion criteria
Patients who cannot consent to study participation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hamazaki |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
545-8586
Address
1-5-7,Asahimachi,Abeno-ku,Osaka city,Osaka
TEL
06-6645-3816
hamazaki@omu.ac.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
545-8586
Address
1-5-7,Asahimachi,Abeno-ku,Osaka city,Osaka
TEL
06-6645-3816
Homepage URL
naho_yama@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Red Cross Hospital, Department of Pediatrics
Osaka Habikino Medical Center, Department of Pediatrics
Yao municipal hospital, Department of Pediatrics
Sumitomo hospital, Department of Pediatrics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
Tel
0666453456
gr-a-knky-ethics@omu.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
大阪公立大学医学部附属病院小児科(大阪)、大阪赤十字病院小児科（大阪）、大阪はびきの医療センター小児科（大阪）、八尾市立病院小児科（大阪）、住友病院小児科（大阪）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 22 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | 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
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055806
