UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057075 |
|---|---|
| Receipt number | R000065242 |
| Scientific Title | Survey of app experience/function/information accuracy, effectiveness/support/satisfaction/improvements in poorly controlled asthma patients |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/02/19 13:39:31 |
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Basic information
Public title
Pilot study with the launch of an app in patients with poorly controlled asthma
Acronym
Asthma app pilot study
Scientific Title
Survey of app experience/function/information accuracy, effectiveness/support/satisfaction/improvements in poorly controlled asthma patients
Scientific Title:Acronym
Survey of Asthma Apps
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Questionnaire survey on app use in patients with poorly controlled asthma
Basic objectives2
Others
Basic objectives -Others
Final adjustments before the launch of the asthma application
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall satisfaction
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Poorly controlled asthma patients attending Kinki University Hospital, Hyogo Medical University Hospital, and St. Francis Society Himeji St. Mary's Hospital
(2) Patients over 18 years old
(3) Patients who can give informed consent to participate in the study of their own free will.
Key exclusion criteria
(1) Patients who have requested not to participate in this study
(2) Patients who are judged by the principal investigator to be inappropriate as subjects of this study
(3) Patients who are participating in clinical trials for other drugs or medical devices
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation Foundation St. Francis Society Himeji St. Mary's Hospital
Division name
Respiratory Medicine
Zip code
670-0801
Address
650 Nitoyono, Himeji City, Hyogo Prefecture
TEL
0792655111
nakajima-y@himemaria.or.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation Foundation St. Francis Society Himeji St. Mary's Hospital
Division name
Respiratory Medicine
Zip code
670-0801
Address
650 Nitoyono, Himeji City, Hyogo Prefecture
TEL
0792655111
Homepage URL
nakajima-y@himemaria.or.jp
Sponsor or person
Institute
Yasuhiro Nakajima/ Respiratory Medicine/ Social Medical Corporation Foundation St. Francis Society Himeji St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
3H Medisolutions, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee
Address
650 Nitoyono, Himeji City, Hyogo Prefecture
Tel
0792655111
kanehiro@himemaria.or.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
近畿大学病院(大阪府)、兵庫医科大学病院(兵庫県)、社会医療法人財団聖フランシスコ会 姫路聖マリア病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Asthma App will be available nationwide starting with the 74th Annual Meeting of the Japanese Society of Allergology.
There is a possibility of transitioning to prospective trials in the future.
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065242
