Digital Self-Management Platform for Adult Asthma: Randomized Attention-Placebo Controlled Trial

Background: Asthma is one of the most common chronic conditions worldwide, with a substantial individual and health care burden. Digital apps hold promise as a highly accessible, low-cost method of enhancing self -management in asthma, which is critical to effective asthma control. Objective: We conducted a fully remote randomized controlled trial (RCT) to assess the efficacy of juli, a commercially available smartphone self -management platform for asthma. Methods: We conducted a pragmatic single-blind, RCT of juli for asthma management. Our study included participants aged 18 years and older who self -identified as having asthma and had an Asthma Control Test (ACT) score of 19 or lower (indicating uncontrolled asthma) at the beginning of the trial. Participants were randomized (1:1 ratio) to receive juli for 8 weeks or a limited attention -placebo control version of the app. The primary outcome measure was the difference in ACT scores after 8 weeks. Secondary outcomes included remission (ACT score greater than 19), minimal clinically important difference (an improvement of 3 or more points on the ACT), worsening of asthma, and health -related quality of life. The primary analysis included participants using the app for 8 weeks (per -protocol analysis), and the secondary analysis used a modified intention -to -treat (ITT) analysis. Results: We randomized 411 participants between May 2021 and April 2023: a total of 152 (37%) participants engaged with the app for 8 weeks and were included in the per -protocol analysis, and 262 (63.7%) participants completed the week -2 outcome assessment and were included in the modified ITT analysis. Total attrition between baseline and week 8 was 259 (63%) individuals. In the per -protocol analysis, the intervention group had a higher mean ACT score (17.93, SD 4.72) than the control group (16.24, SD 5.78) by week 8 (baseline adjusted coefficient 1.91, 95% CI 0.31-3.51; P =.02). Participants using juli had greater odds of achieving or exceeding the minimal clinically important difference at 8 weeks (adjusted odds ratio 2.38, 95% CI 1.20-4.70; P =.01). There were no between group differences in the other secondary outcomes at 8 weeks. The results from the modified ITT analyses were similar. Conclusions: Users of juli had improved asthma symptom control over 8 weeks compared with users of a version of the app with limited functionality. These findings suggest that juli is an effective digital self -management platform that could augment existing care pathways for asthma. The retention of patients in RCTs and real -world use of digital health care apps is a major challenge.