Randomized attention-placebo controlled trial of a digital self-management platform for adult asthma

Abstract

AbstractBackgroundAsthma is one of the most common chronic conditions worldwide, with a substantial individual, societal and healthcare 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.ObjectiveWe conducted a fully remote trial to assess the efficacy of juli, a commercially available smartphone self-management platform for asthma.MethodsWe conducted a pragmatic single-blind, randomized controlled trial of juli for asthma management. Our study included participants aged 18 and above with asthma and had an asthma control test (ACT) score of 19 or less (indicating poorly controlled asthma) at the beginning of the trial. Participants were randomized (1:1 ratio) to receive juli for eight weeks or a limited attention-placebo control version of the app. The primary endpoint was the difference in ACT scores after eight weeks. Secondary endpoints included eight-week remission (ACT score greater than 19), minimal clinically important difference (an improvement of three or more points on the ACT), worsening of asthma, and health-related quality of life. The primary analysis included participants using the app for eight weeks (per-protocol), a secondary analysis used modified intention-to-treat.ResultsWe randomized 411 participants between May 2021 and April 2023: 152 engaged with the app for eight weeks and were included in the per-protocol analysis, 262 completed the week two outcome assessment and were included in the modified intention-to-treat analysis.In the per-protocol analysis, the intervention group had a higher mean ACT score (17.93, standard deviation = 4.72) than the control group (16.24, standard deviation = 5.78) by week eight (baseline adjusted β-coefficient 1.91, 95% confidence intervals = 0.31 to 3.51, p=0.020). Participants using juli had greater odds of achieving or exceeding the minimal clinically important difference at eight weeks (adjusted odds ratio = 2.38, 95% confidence intervals = 1.20 to 4.70, p=0.013). There were no between-group differences in the other secondary outcomes at eight weeks. The results from the modified intention-to-treat analysis were similar.ConclusionsUsers of juli had improved asthma symptom control over eight 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.Trial RegistrationThe trial was pre-registered (ISRCTN87679686).