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

Abstract

Importance: Digital health technologies may improve asthma self-management, but evidence is limited in this area.

Objective: To investigate the effect of a digital asthma self-management (DASM) program on asthma symptoms in adults.

Design, setting, and participants: 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.

Intervention: The app-based DASM program provided tailored notifications, symptom logging, wearable device integration, and other tools.

Main outcomes and measures: 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.

Results: 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).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT04609644.

Figure 1.. Selected Application Features and Components of the Digital Asthma Self-Management Program

eAppendix in Supplement 2 provides a detailed program description.

Figure 2.. Participant Flow Diagram

DASM indicates digital asthma self-management; PRO, patient-reported outcome; and UC, usual care.

Figure 3.. Change in Asthma Control Test (ACT) Score by Arm and Baseline Asthma Control Status

Differences between arms in ACT change (treatment effects) are shown. Point estimates are marginal means derived from linear mixed-effects models. Both models control for insurance type, ethnicity, race, age, gender, and self-reported smoking status at baseline. A, Primary analysis of participants with uncontrolled asthma (ACT score, ≤19) at baseline (prespecified). Mean change after 12 months was 4.6 (95% CI, 4.1-5.2) points (P < .001) for digital asthma self-management (DASM) arm and 1.8 (95% CI, 1.3-2.4) points (P < .001) for the control arm. B, Secondary analysis of those with controlled asthma (ACT score, ≥20) at baseline. Mean change was 0.7 (95% CI, 0.2-1.2) points (P = .005) for the DASM arm and −1.0 (95% CI, −1.4 to −0.5) points (P < .001) for the control arm. (the between-arm difference in change is slightly less than expected due to rounding). Error bars represent 95% CIs. ^aP < .001 for time × arm interaction.

Figure 4.. Treatment Effects and Symptom Log Counts by Subgroup

Results are filtered to participants with uncontrolled asthma at baseline (Asthma Control Test [ACT], ≤19), as prespecified. A, Results were estimated by linear mixed-effects modeling (Methods section and eTable 10 in Supplement 2). B, Counts by coverage type are adjusted for ethnicity and race to account for subgroup overlap. Counts by ethnicity and race are similarly adjusted (eTable 13 in Supplement 2 shows unadjusted results). App opens show the same pattern (eFigure 2 in Supplement 2). Boxes represent IQRs; vertical lines, medians; and whiskers, the most extreme values within 1.5 × IQR. DASM indicates digital asthma self-management. ^aCalculated for treatment effect within subgroups. ^bCalculated for differences in effect between subgroups. ^cControl participants are excluded, as they did not have access to symptom logging or other DASM features.