BACKGROUND
A written action plan (WAP) for managing asthma exacerbations is recommended.
OBJECTIVE
We compared the effect on unscheduled medical contacts (UMCs) of a digital action plan (DAP) accessed via a smartphone Web application (app) combined with a WAP on paper versus the same WAP alone.
METHODS
This randomized, unblinded, multicenter (offline recruitment in private offices and public hospitals by physicians), parallel-group trial included asthma patients who were either children (6–12 years) or adults (18–60 years) and who had experienced at least one severe exacerbation in the previous year. They were randomized to WAP or DAP+WAP in a 1:1 ratio. The DAP (fully automated) provided treatment advice according to the severity and previous pharmacotherapy of the exacerbation. Participants were interviewed at three, six, nine, and 12 months to record exacerbations, UMCs, and WAP and DAP use, including the subjective evaluation (availability, usefulness) of the action plans, by a research nurse.
RESULTS
Two-hundred and eighty participants were randomized of whom 33 were excluded due to the absence of follow-up data after randomization, living 247 participants (93 children, 154 adults). The WAP group had 123 participants (45 children, mean age 8.3±2.0 years; and 78 adults, 36.3±12.7 years) and the DAP+WAP group 124 participants (48 children, 9.0±1.9 years; and 76 adults, 34.5±11.3 years). Overall, the annual severe exacerbation rate was 0.53. The mean UMC number/year was 0.31±0.62 in the WAP group and 0.37±0.82 in the DAP+WAP group (mean difference, 0.06; 95% confidence interval, -0.12 to 0.24, P=.823). Use per patient with at least one moderate or severe exacerbation was higher for the WAP (33/65 versus 15/63 for the DAP, P=.002). Thus, participants were more likely to use the WAP as compared to the DAP despite non-significant difference for the subjective evaluation of both action plans.
CONCLUSIONS
The DAP was used less often than the WAP and did not decrease the number of UMCs compared to the WAP alone.
CLINICALTRIAL
ClinicalTrials.gov Identifier: NCT02869958