Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059259) titled 'The Effect of Input Frequency in Asthma Management Apps and Medication Adherence on Oral Steroid Use' 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 study investigates the impact of introducing an asthma management app to patients with poor control on their use of rescue oral steroids, by monitoring their input frequency and medication adherence rates.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 1) For patients with poorly controlled asthma who provide consent during their visit, install the 3H P-Guardian app from the Google Play Store/iPhone App Store. Information is shared with the healthcare provider via the 3H P-Guardian MEDICAL SYSTEM through the cloud PHR server (AWS). Patients enter 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.
Registration Period: 20 months, April 1, 2025 to December 31, 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 undergoing outpatient treatment who use an asthma management app during the period from April 1, 2025, 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 drug or medical device clinical trials
3. Patients participating in other clinical trials of pharmaceuticals or medical devices
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 01 Day
Anticipated trial start date - 2025 Year 10 Month 25 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=R000067782
Disclaimer: Curated by HT Syndication.