The effect of a smartphone application self-management programme on clinical health outcomes in patients with Chronic Obstructive Pulmonary Disease: A feasibility randomised controlled trial

Abstract

Background: Chronic Obstructive Pulmonary Disease (COPD) is an incurable disease that results in frequent exacerbations leading to regular hospitalisations among this cohort. Frequent exacerbations and hospitalisations can negatively impact clinical health outcomes resulting in increased morbidity and mortality. There are limited studies exploring the use of a comprehensive self-management programme using a smartphone application (app) for patients with COPD over 12 months. Aim: To investigate the effect patterns of a smartphone application self-management programme on clinical health outcomes in patients with COPD. To assess the feasibility and provide valuable data for expanding to a multi-centre study. Trial design: This was a feasibility three-arm parallel randomised control trial (RCT) that included 92 participants. The self-management app used in this study was commercially available but was modified to suit the needs of the COPD population. Participants were randomly allocated into intervention arm 1 which included the self-management smartphone app and monthly phone calls (n=31), intervention arm 2 included the self-management smartphone app (n=31) and arm 3 was standard respiratory outpatient care (n=30). All arms received standard respiratory outpatient care. Primary objective was to explore the effect patterns of a smartphone application self-management programme compared with standard respiratory outpatient care on the rate of COPD exacerbations managed by the GP or in the hospital setting. Secondary objectives included, engagement, breathlessness, physical activity, health related quality of life and self-efficacy. Results: There were fewer exacerbations in the intervention arm compared to the control arm at six months in the hospital setting (p-value 0.033). The intervention arms had a lower risk of developing an exacerbation at six months in both the GP (p-value 0.0165) and hospital setting (p-value 0.006) compared to the control arm. The intervention arm demonstrated a statistically significant increase in exercise capacity at six and twelve months respectively (p-value 0.023, p=0.039) and also in step count at 12 months (p-value 0.009) compared to the control arm. Arm 1 reported better engagement than arm 2 at six (p-value= 0.021) and twelve months (p-value= 0.039). The monthly phone calls in arm 1 did not have a statistically significant effect on engagement at three, six, and twelve months of follow up. The impact of the monthly phone calls on the primary outcome was not explored in this study. Conclusion: This was the first Irish study to demonstrate that it is feasible to use a smartphone app to support a comprehensive self-management programme for COPD patients. Furthermore, this feasibility RCT demonstrated a statistical significance in the intervention arms whereby there were fewer exacerbations presenting in the hospital setting, improved exercise capacity and physical activity in comparison to the standard respiratory outpatient care.