Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jul 27, 2022
Date Accepted: Feb 28, 2023
Date Submitted to PubMed: May 31, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Digital Action Plan (Web App) for Managing Asthma Exacerbations: a Randomized Trial
ABSTRACT
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. Clinical Trial: ClinicalTrials.gov Identifier: NCT02869958
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