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

Abstract

Background Chronic Obstructive Pulmonary Disease (COPD) negatively impacts clinical health outcomes, resulting in frequent exacerbations, increased hospitalisations, worsening respiratory symptoms, reduced physical activity, deteriorated quality of life, and diminished self-efficacy. Previous studies demonstrated that self-management programmes tailored for COPD participants enhance self-management decisions leading to a significant improvement in their clinical health outcomes. However, there are limited studies pertaining to the use of a comprehensive self-management programme using a smartphone application (app) for people with COPD over 12 months.

The aim of this study is to investigate the effectiveness of a smartphone application self-management programme on clinical health outcomes in patients with COPD.

Methods A feasibility three-arm parallel randomised control trial (RCT) was conducted that included 92 participants. Participants were randomised 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. The primary outcome was the number of COPD exacerbations reviewed in the general practitioner (GP) and the hospital setting. Secondary outcomes included, engagement, breathlessness, physical activity, health related quality of life and self-efficacy.

Results There was a statistically significant difference, p-value 0.033 indicating less exacerbations in the intervention arm compared to the control arm at six months in the hospital setting. The intervention arms had a statistically significant difference indicating 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. Furthermore, the intervention arm demonstrated a statistically significance difference in exercise capacity (p-value 0.039) and step count (p-value 0.009 compared to the control arm. The majority of participants engaged with the app over the 12 months.

Conclusion This feasibility study illustrates benefits such as reduced exacerbations, improved exercise capacity and physical activity resulting in reduced hospitalisations. It is feasible to conduct a larger multi-centre trial exploring the effect of a smartphone app self-management programme on clinical health outcomes in patients with COPD.

The ClinicalTrial.gov ID number assigned to this study was NCT05061810.