Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059258) titled 'Optimizing Asthma Treatment with an Asthma App:' on Oct. 25.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Social Medical Foundation Society of St. Francis Himeji St. Mary's Hospital
Condition:
Condition - bronchial asthma
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 18
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 Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 01 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067781
Disclaimer: Curated by HT Syndication.
