A Smartphone App Self-Management Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial of Clinical Outcomes

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Abstract
Background: Chronic obstructive pulmonary disease (COPD) negatively impacts clinical health outcomes, resulting in frequent exacerbations, increased hospitalizations, reduced physical activity, deteriorated quality of life, and diminished self-efficacy. Previous studies demonstrated that a self-management program tailored for adults with COPD improves self-management decisions, resulting in a positive effect on clinical health outcomes. Limitations of these studies include issues regarding heterogeneity among interventions used, patient population characteristics, outcome measures, and longitudinal studies. Limited studies focused on the use of a comprehensive self-management program using a smartphone app for adults with COPD over 12 months. Objective: This study aimed to explore the effectiveness of a smartphone app self-management program and monthly phone calls compared with standard respiratory outpatient care on clinical health outcomes in adults with COPD. Methods: This was a 3-arm parallel pilot randomized controlled trial (RCT) that included 92 participants. Participants were randomized into intervention arm 1, which included a self-management smartphone app and monthly phone calls (n=31); intervention arm 2, which included a self-management smartphone app (n=31); and arm 3, which was standard respiratory outpatient care (n=30). All arms received standard respiratory outpatient care. The primary outcome was a binary indicator equal to 1 if participants reported attendance to a general practitioner (GP) and or a hospital setting as a result of an exacerbation and 0 otherwise. This indicator was recorded at 6 months and 12 months from the baseline. Secondary outcomes included engagement, breathlessness, physical activity, health-related quality of life, and self-efficacy. Results: There was a statistically significant difference (P=.03), indicating fewer exacerbations in the intervention arm 2 compared with the control arm at 6 months in the hospital setting. The intervention arms had a statistically significant difference indicating a lower risk of developing an exacerbation at 6 months in both the GP (P=.01) and hospital setting (P=.006) compared to the control arm. Furthermore, intervention arm 1 demonstrated a statistically significant difference in exercise capacity at 6 and 12 months (P=.02 and P=.03). The intervention arm 2 illustrated a statistically significant difference in step count (P=.009) compared to the control arm. The majority of participants (60%, 33/55) used the app over the 12-month period. Conclusions: This study demonstrated that a smartphone app self-management program had a positive effect on clinical health outcomes for participants with COPD in comparison to standard respiratory outpatient care. This study illustrated benefits such as reduced exacerbations resulting in fewer hospitalizations, improved exercise capacity, and physical activity among the intervention arms. This was a single-center study, which was limited in power to demonstrate significant effects on all measured outcomes but paves the way for a larger, fully powered multicenter trial exploring the effect of a smartphone app self-management program on clinical health outcomes in adults with COPD. Trial Registration: ClinicalTrials.gov NCT05061810; https://clinicaltrials.gov/study/NCT05061810

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