A smart mHealth tool versus a paper action plan to support self-management of COPD exacerbations: a randomised controlled trial

Background: COPD exacerbations are often poorly recognized or self-managed, leading to increased disease burden and healthcare utilisation. Objective: To examine the effects of a smart mHealth tool that detects early exacerbation onset and directly provides treatment advices without the interference of healthcare professionals. Methods: In a multicenter, pragmatic, two-arm randomized controlled trial participants used the mHealth tool (intervention group) or a paper action plan (control group) when they experienced respiratory symptom worsening during 12-months follow-up. Primary outcome was ‘exacerbation-free weeks’. Secondary outcomes were health status, self-efficacy, self-management behaviour, healthcare utilization, and usability. We used negative binomial, multilevel logistic, and generalised estimating equation regression models. Results: We randomised 87 COPD patients (43 intervention group). We found no statistically significant differences between intervention and control group in exacerbation-free weeks (mean 30.6±13.3 vs. 28.0±14.8 weeks respectively; rate ratio 1.21, 95%CI 0.77-1.91), nor differences in health status, self-efficacy, self-management behaviour, and healthcare utilization. Patients valued the mHealth tool as more supportive than the paper action plan and considered its usability as good to excellent. Discussion: This study did not show beneficial effects of mHealth compared to paper action plans for COPD exacerbations, although participants were positive about its supportive function and usability. mHealth may be an alternative for COPD patients who prefer a digital tool instead of a paper action plan.