Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

Abstract

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD. We explored the impact of myCOPD in patients with mild-moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score. Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, -1.27 (95% CI -4.47-1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09-1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46-5.85) in favour of myCOPD. The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

Conflict of interest statement

Conflict of interest: M.G. Crooks has nothing to disclose. Conflict of interest: J. Elkes has nothing to disclose. Conflict of interest: W. Storrar has nothing to disclose. Conflict of interest: K. Roy has nothing to disclose. Conflict of interest: M. North is an employee of mymhealth Limited. He reports grants from SBRI during the conduct of the study and personal fees from mymhealth Limited outside the submitted work. Conflict of interest: A. Blythin reports grants from Innovate UK during the conduct of the study and is an employee of mymhealth Limited. Conflict of interest: A. Watson has nothing to disclose. Conflict of interest: V. Cornelius has nothing to disclose. Conflict of interest: T. Wilkinson is the founder and directior of MyMHealth. He reports grants from Innovate UK during the conduct of the study; and personal fees and other support from MyMHealth, grants from GSK, grants and personal fees from AstraZeneca and Synairgen, and personal fees from BI, outside the submitted work.

Copyright ©ERS 2020.

Figures

FIGURE 1

CONSORT flow diagram for the study. The participant re-entered in myCOPD was still excluded from analysis as 6 months had elapsed between baseline and post-baseline assessments.

FIGURE 2

Participants’ profiles of using the app at least once per day over the trial period. Data shown here were available for 26 of the 29 participants; first day is defined as baseline visit. Each row in the figure corresponds to the profile of a participant where a coloured square means an activity, e.g. watched a video or reported symptom score, recorded in the app for that day.

FIGURE 3

Mean change in COPD assessment test (CAT) score for each timepoint compared to baseline. Participants are included at each timepoint if a CAT score was recorded. For myCOPD there are 29 participants included at baseline, 25 at month 1 and 24 at month 2 and end of study (EOS). For usual care there are 31 participants included at baseline, 30 at month 1, 29 at month 2 and 30 at end of study.