An Integrated Electronic Patient-Reported Outcome-Guided COPD Management Strategy Incorporating Adjunctive...

Background/Objectives: Chronic obstructive pulmonary disease (COPD) is characterized by persistent symptoms and fluctuating disease status. Effective COPD management requires not only alleviating symptom burden but also maintaining disease stability. An integrated management strategy added to usual care, combining adjunctive acupuncture for symptom control with electronic patient-reported outcome (ePRO)-guided symptom monitoring and timely clinical responses, may provide a novel approach to optimize COPD care. This trial will evaluate whether this management strategy can improve long-term COPD outcomes compared with usual care alone. Methods: This is an open-label, randomized controlled trial with blinded outcome assessments. A total of 172 patients with stable COPD will be randomized 1:1 to usual care or intervention group. The intervention consists of an initial symptom-control phase followed by an ePRO-guided monitoring and response phase with predefined clinical management adjustments. We will follow up participants for 12 months and collect data every 2 months to assess hospitalization, exacerbations, mortality, health status and safety. All analyses will adhere to the intention-to-treat principle. The primary outcome (i.e., time to first COPD-related hospitalization) will be analyzed using a cause-specific Cox proportional hazards model, with death before hospitalization treated as a competing event. The cumulative incidence of COPD-related hospitalization will be estimated using the Aalen-Johansen estimator. Conclusions: This study will evaluate, compared with usual care alone, whether an integrated ePRO-guided COPD management strategy incorporating adjunctive acupuncture could provide additional benefits. As this is the first trial of this integrated intervention, the findings should be considered preliminary and cannot determine the separate effects of the individual components. This study may provide a patient-centered management model for COPD and inform future exploration of integrative care.