Abstract
BackgroundMany patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs.ObjectiveThis study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals.MethodsIn a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models.ResultsOf the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good.ConclusionsThis study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan.Trial RegistrationClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.
Highlights
Exacerbations in chronic obstructive pulmonary disease (COPD) are acute events of transient worsening of the respiratory condition
This study did not show beneficial effects of a smart mobile health (mHealth) tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan
Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan
Summary
Exacerbations in chronic obstructive pulmonary disease (COPD) are acute events of transient worsening of the respiratory condition. Telemonitoring, in which patients record and send information on symptoms or physiological measurements to a supervising clinician, may be an alternative approach to self-management strategies to reduce the impact of COPD exacerbations. We have developed [17] and validated [18] an innovative mobile health (mHealth) tool, called the Adaptive Computerized COPD Exacerbation Self-management Support system. This tool aims to tailor self-management support more efficiently and continuously than with a written action plan but without heavily increasing the involvement of health care professionals to monitor input, as is the case with telemonitoring. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs
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