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 2024/03/27 17:31:44

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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

Email

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


Email

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

Email

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


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

Enrolling by invitation

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

2024 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055806


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name