A Clinical Observational Study of a Mobile Health Application for Japanese Adult Patients with Asthma (Preprint)

BACKGROUND Inappropriate asthma control reduces quality of life and causes increased exacerbations. Mobile health (mHealth) employs information and communication technology for surveying health-related issues. OBJECTIVE This noninterventional, observational study assessed current real-world asthma control levels among Japanese patients with asthma and cough variant asthma (CVA) using the Zensoku-Log app. METHODS We developed the app using the ResearchKit platform and conducted a mobile-based, self-reporting, observational survey among patients with asthma and CVA. The app was downloaded 7855 times between February 2016 and February 2018, and enabled collection of data on symptoms, comorbidities, quality of life, medications, asthma control, and adherence. RESULTS Of the 1744 eligible participants (median age 33 years; range 20-74 years; male-to-female ratio 38.7:61.3), 50.97% (889/1744) reported unscheduled visits, 62.84% (1096/1744) reported regularly scheduled visits, 23.14% (402/1737) smoked, and 40.75% (705/1730) had pets. In addition, 91.89% (1598/1739) of participants had atopic predisposition, including allergic rhinitis and atopic dermatitis. Daily inhaled corticosteroid and oral corticosteroid treatment had been prescribed for 89.45% (1552/1735) and 22.07% (383/1735) of participants, respectively. Although an asthma control questionnaire demonstrated poor asthma control in 58.48% (1010/1727), a leukotriene receptor antagonist, theophylline, and a long-acting muscarinic antagonist had been prescribed for only 30.66% (532/1735), 15.91% (276/1735), and 4.38% (76/1735), respectively. The Adherence Starts with Knowledge 12 total score was 29. In the 421 participants who repeated the questionnaire, asthma control increased significantly between the initial and last rounds (P=.002). CONCLUSIONS Users of this mHealth app in Japan had poorly controlled asthma and may need more treatment for asthma and their comorbidities. Repeated app users demonstrated improved asthma control. TRIAL REGISTRATION UMIN Clinical Trial Registry UMIN000021043; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023913.