A Digital Asthma Self-Management Program for Adults: A Randomized Clinical Trial.

Abstract

Digital health technologies may improve asthma self-management, but evidence is limited in this area. To investigate the effect of a digital asthma self-management (DASM) program on asthma symptoms in adults. Patient-reported outcome results were reported from a randomized, pragmatic, parallel-arm, open-label, decentralized clinical trial. Adults with asthma were recruited via email, enrolled from October 29, 2020, through November 4, 2021, and were randomized to DASM or usual care (control). Participants completed study activities outside a clinical setting. Data were analyzed between October 13, 2023, and November 29, 2024. The app-based DASM program provided tailored notifications, symptom logging, wearable device integration, and other tools. Change in the Asthma Control Test (ACT) was a primary outcome. The ACT is a validated measure of asthma control. Secondary outcomes included engagement and self-reported medication adherence. Nine hundred and one participants were enrolled, with data available for 899 (639 [71.1%] female; mean [SD] age, 36.6 [10.5] years). For subgroup analyses, 195 participants (21.7%) were African American; 125 (13.9%), Hispanic or Latino; 680 (75.6%), commercially insured; and 219 (24.4%), Medicaid insured. Prespecified analyses of participants with uncontrolled asthma at baseline (n = 550) showed improvements after 12 months by 4.6 (95% CI, 4.1-5.2) ACT points among DASM participants (P < .001) and 1.8 (95% CI, 1.3-2.4) ACT points among controls (P < .001) (adjusted difference, 2.8 [95% CI, 2.0-3.6] points; P < .001). Race moderated this effect. At 12 months, the difference between arms in ACT change favored DASM over control by 1.0 (95% CI, -0.7 to 2.7) points (P = .26) for African American participants and 3.3 (95% CI, 2.4-4.2) points (P < .001) for participants not endorsing African American race (adjusted difference, -2.3 [95% CI, -4.2 to -0.4] points; P = .02 for interaction). Moderation was not observed by insurance (Medicaid vs commercial; adjusted difference, 1.0 [95% CI, -0.8 to 2.8] points; P = .18 for interaction) or ethnicity (Hispanic or Latino vs non-Hispanic; adjusted difference, 1.0 [95% CI, -1.3 to 3.3] points; P = .70 for interaction). In this randomized clinical trial of DASM, improved asthma control was observed relative to usual care. Program adaptations may be appropriate to confer benefit throughout diverse populations. ClinicalTrials.gov Identifier: NCT04609644.