UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059258 |
|---|---|
| Receipt number | R000067781 |
| Scientific Title | A Multicenter Prospective Study Aimed at Improving Symptom Control |
| Date of disclosure of the study information | 2025/10/25 |
| Last modified on | 2025/10/01 15:05:30 |
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Basic information
Public title
Optimizing Asthma Treatment with an Asthma App:
Acronym
APP-ACT study(App-based Optimization of Asthma Control)
Scientific Title
A Multicenter Prospective Study Aimed at Improving Symptom Control
Scientific Title:Acronym
APP-ACT study(App-based Optimization of Asthma Control)
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective study evaluates the impact of asthma app use on patients with poorly controlled asthma, assessing its contribution to improving ACT scores, reducing asthma exacerbations, decreasing rescue oral steroid use, enhancing quality of life, and serving as a complementary measure to clinical remission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in ACT Scores: Average change in ACT scores from the start of app use to 6 months later
Key secondary outcomes
Frequency of asthma exacerbations over 6 months
Frequency of oral steroid rescue medication use over 6 months
Change in AHQ-33 JAPAN score over 6 months
Change in adherence rate for regular inhaled and oral medications based on app records
Frequency of emergency/out-of-hours outpatient visits and hospitalizations: Number of emergency/out-of-hours outpatient visits and hospitalizations over 6 months
Change in maintenance oral steroid dosage over 6 months
Frequency of asthma exacerbations over 6 months Frequency of oral steroid rescue medication use over 6 months Change in AHQ-33 JAPAN score over 6 months Change in adherence rate to regular inhaled and oral medications based on app records Frequency of emergency/after-hours outpatient visits and hospitalizations: Number of emergency/after-hours outpatient visits and hospitalizations over 6 months Change in maintenance oral steroid dosage over 6 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Method
1) For patients with poorly controlled asthma who consent during their visit, install the 3H P-Guardian app from the Google Play Store/iPhone App Store. Information is shared with the medical institution via the 3H P-Guardian MEDICAL SYSTEM through the cloud PHR server (AWS). Patients input the following items:
1 ACT (Asthma Control Test) (once per month)
2 Presence of exacerbations (Daily)
3 Use of rescue oral steroids (Daily)
4 Free comments (Daily)
5 Adherence to regular medication (Daily)
6 AHQ-33 JAPAN (Health-Related Quality of Life Survey) (Once every 3 months)
2) Analyze information aggregated through the 3H P-Guardian MEDICAL SYSTEM.
3) Report any changes in medications used for asthma treatment to the study office immediately upon occurrence.
Registration Period: 6 months, January 1, 2026 to June 30, 2026
Analysis Period: 12 months, January 1, 2027 to December 31, 2027
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with poorly controlled asthma (ACT score <20) undergoing outpatient treatment who use an asthma management app during the period from January 1, 2026, to December 31, 2026.
2. Patients aged 18 years or older.
3. Patients who can provide informed consent to participate in the trial of their own free will.
Key exclusion criteria
1. Patients who declined to participate in this study
2. Patients deemed unsuitable for this study by the principal investigator
3. Patients participating in other clinical trials of drugs or medical devices
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Foundation Society of St. Francis Himeji St. Mary's Hospital
Division name
Respiratory Medicine
Zip code
6700801
Address
650 Nibuno, 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 Foundation Society of St. Francis Himeji St. Mary's Hospital
Division name
Respiratory Medicine
Zip code
6700801
Address
650 Nibuno, Himeji City, Hyogo Prefecture
TEL
0792655111
Homepage URL
nakajima-y@himemaria.or.jp
Sponsor or person
Institute
Social Medical Foundation Society of St. Francis Himeji St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University Hospital
Department of Respiratory and Hematology Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee
Address
650 Nibuno, Himeji City, Hyogo Prefecture
Tel
0792655111
nakajima-y@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 25 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067781
